SUPERA PERIPHERAL STENT SYSTEM S-65-040-120-P6

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 2020-03-16 for SUPERA PERIPHERAL STENT SYSTEM S-65-040-120-P6 manufactured by Abbott Vascular.

Event Text Entries

[183668829] The device was returned. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10


[183668830] It was reported that the procedure was performed to treat a 75% stenosed and heavily calcified lesion in the mid superficial femoral artery. A 6f sheath and a ht command 18 guide wire were advanced to the lesion. Following pre-dilatation, a 6. 5x40mm supera self-expanding stent system was advanced and an attempt to deploy the stent was performed. The thumb slide was advanced; however, the last 1cm failed to deploy despite further thumb slide advancements. The deployment lock was released; however, the stent did not fully deploy. The delivery system was pulled slowly out of the anatomy under fluoroscopy and the stent completely deployed from the system. The implanted stent seemed to be elongated by 30% at the 1cm section that deployed with the removal of the delivery system. 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 Number2024168-2020-02502
MDR Report Key9837791
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-16
Date of Report2020-03-16
Date of Event2020-02-28
Date Mfgr Received2020-03-02
Device Manufacturer Date2019-06-18
Date Added to Maude2020-03-16
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 # 2024168
Manufacturer Street26531 YNEZ ROAD
Manufacturer CityTEMECULA CA 925914628
Manufacturer CountryUS
Manufacturer Postal Code925914628
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSUPERA PERIPHERAL STENT SYSTEM
Generic NameSELF EXPANDING PERIPHERAL STENT SYSTEM
Product CodeNIP
Date Received2020-03-16
Returned To Mfg2020-03-13
Model NumberS-65-040-120-P6
Catalog NumberS-65-040-120-P6
Lot Number9061861
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerABBOTT VASCULAR
Manufacturer Address26531 YNEZ RD. TEMECULA CA 925914628 US 925914628


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-16

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