GRAFTMASTER 1012820-19

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-09 for GRAFTMASTER 1012820-19 manufactured by Abbott Vascular.

Event Text Entries

[182743449] (b)(4). The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the lot number was not provided. It was reported that the procedure was performed to treat a right cavernous carotid fistula. It should be noted that the graftmaster rapid exchange (rx), coronary stent graft system, instructions for use, states: the graftmaster rx is indicated for use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts greater than or equal to 2. 75 mm in diameter. In this case, it is unknown if the ifu deviation directly caused or contributed to the event. The investigation was unable to determine a conclusive cause for the reported difficulties. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The other 4. 5x19 graftmaster device referenced and the 4. 5x26 graftmaster referenced are being filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10


[182743450] It was reported that the procedure was performed to treat a right cavernous carotid fistula. A 4. 5x19mm graftmaster covered stent was implanted, but the stent could only be expanded to 3. 5mm diameter instead of 4. 5mm despite dilatation up to rated burst pressure. The fistula was still permeable, so another 4. 5x19mm graftmaster covered stent was implanted to continue to treat the fistula. However, this stent had the same dilatation issue. The fistula was, again, still permeable, so a 4. 5x26mm graftmaster covered stent was implanted to continue to treat the fistula. This stent also had the same dilatation issue, so a coil was used to finish treating the fistula. There was no intervention performed to treat the stents. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2024168-2020-02175
MDR Report Key9808502
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-09
Date of Report2020-03-09
Date of Event2020-02-14
Date Mfgr Received2020-02-14
Date Added to Maude2020-03-09
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LINDSEY BELL
Manufacturer Street26531 YNEZ RD.
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal925914628
Manufacturer Phone9519143996
Manufacturer G1ABBOTT VASCULAR, REG # 3005718570 (P099)
Manufacturer StreetCASHEL ROAD
Manufacturer CityCLONMEL TIPPERARY
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGRAFTMASTER
Generic NameCORONARY STENT DELIVERY SYSTEM
Product CodeMAF
Date Received2020-03-09
Catalog Number1012820-19
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-03-09

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