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 2020-03-26 for SUPERA PERIPHERAL STENT SYSTEM S-65-080-080-P6 manufactured by Abbott Vascular.
[188405124]
The reported patient effect of thrombosis is listed in the supera instruction for use as a potential adverse effect of peripheral percutaneous intervention. The device was not returned for evaluation. The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported. The reported patient effect of thrombosis is listed in the supera instruction for use as a potential adverse effect of peripheral percutaneous intervention. Based on the information provided, a conclusive cause for the reported stent material deformation and subsequent patient effects could not be determined. It may be possible that the supera stent was subjected to stress/fatigue or repetitive movement due to anatomical conditions and location of the implant; however, this could not be confirmed. The additional therapy/non-surgical treatment, surgical procedure, treatment with medications and hospitalization were due to case circumstances. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[188405125]
It was reported that the supera self expanding stent (ses) appeared twisted 7 months after it was implanted in a veign graft bypass popliteal segment. The patient was re-hospitalized and treated with overnight thrombolysis for the blocked graft. There was a thrombus about 10 cm above the stent and was confirmed with angiography. Thrombus was discovered because the patient was experiencing rest pain. It was attempted to untwist the stent with balloon angioplasty as well as placing an additional stent. The patient has been referred to vascular surgery to consider options. The physician remarked that they were pleased with the performance of the ses. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02939 |
| MDR Report Key | 9883901 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-26 |
| 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 # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERA PERIPHERAL STENT SYSTEM |
| Generic Name | SELF EXPANDING PERIPHERAL STENT SYSTEM |
| Product Code | NIP |
| Date Received | 2020-03-26 |
| Catalog Number | S-65-080-080-P6 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-26 |