MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-25 for GRAFTMASTER 1012582-26 manufactured by Abbott Vascular.
[184912922]
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[184912923]
It was reported that the procedure was performed to treat a pre-existing perforation in the heavily calcified anterior descending artery. The 4. 0x26mm graftmaster was placed on an unspecified guidewire but would not load past the midpoint of the balloon. Per the physician, the use of the 4. 0x26 graftmaster contributed to complications. A shorter length (4. 0x19mm) graftmaster stent was used as it was the only covered stent available and it did not cover the full length of the pre-existing perforation. The graftmaster stent was successfully deployed at 16 atmospheres without any reported device issues. The patient went into cardiac shock and tamponade. Cpr and pericardiocentesis were done but were unsuccessful. Per the physician, the patient? S health had already been declining prior to the use of the graftmaster device and was not a candidate for surgery and there was no alternative option. The patient died within 3 minutes of the perforation. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02879 |
| MDR Report Key | 9879526 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2019-07-16 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GRAFTMASTER |
| Generic Name | CORONARY STENT DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 2020-03-25 |
| Model Number | 1012582-26 |
| Catalog Number | 1012582-26 |
| Lot Number | 9071641 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-25 |