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 2020-03-30 for SUPERA PERIPHERAL STENT SYSTEM 42055150-120 manufactured by Abbott Vascular.
[185729798]
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
[185729799]
It was reported that the procedure was performed to treat a lesion in the superficial femoral artery (sfa). During advancement of the supera stent delivery system, resistance was noted. The device was pulled back to inspect and it was realized that about 0. 5 cm of the stent was deployed. No issues were noted during device preparation. There was no reported adverse patient effect or a clinically significant delay in procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03126 |
| MDR Report Key | 9901554 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-08-20 |
| Date Added to Maude | 2020-03-30 |
| 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 | 2020-03-30 |
| Catalog Number | 42055150-120 |
| Lot Number | 9082062 |
| 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 | 2020-03-30 |