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 2020-03-27 for SUPERA PERIPHERAL STENT SYSTEM 42065200-120 manufactured by Abbott Vascular.
[185727304]
The device was not returned for evaluation. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot. Based on the information provided, a definitive cause for the difficulties could not be determined. It may be possible that the vessel diameter was narrowed in some locations causing the stents to elongate during deployment; however, this could not be confirmed. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The additional supera device referenced is being filed under a separate medwatch report.
Patient Sequence No: 1, Text Type: N, H10
[185727305]
It was reported that the procedure was performed to treat a lesion in the popliteal artery and femoral artery. Following pre-dilatation, a 6. 5x200mm supera self-expanding stent (ses) was deployed in the popliteal artery and 6. 5x100mm supera ses were deployed in the femoral artery; however, they seemed to be longer than the size on the label. The 6. 5x200mm ses measures around 300mm post-deployment and the 6. 5x100mm ses measures around 180mm post-deployment, both stents elongated more than 10%. Both sess were removed under fluoroscopy. The procedure was successfully completed with no consequence to the patient. There was no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03043 |
| MDR Report Key | 9890911 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-02-13 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2018-10-03 |
| Date Added to Maude | 2020-03-27 |
| 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 | 2020-03-27 |
| Catalog Number | 42065200-120 |
| Lot Number | 8100361 |
| 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 | 2020-03-27 |