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 2020-03-16 for SUPERA PERIPHERAL STENT SYSTEM S-55-150-120-P6 manufactured by Abbott Vascular.
[183667403]
The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
Patient Sequence No: 1, Text Type: N, H10
[183667404]
It was reported that the procedure was to treat the heavily calcified left superficial femoral artery. The vessel diameter was 6. 0 mm and the lesion was pre-dilated with a 5. 0 mm and 6. 0 mm balloon dilatation catheter (bdc). Atherectomy was not performed and a 6fr 10 cm sheath was used. The supera self expanding stent (ses) was advanced and as the ses was being deployed, the ratchet stopped catching when the stent was about a third deployed. The ratchet was unable to be re-engaged so the entire delivery system with the stent was removed and a new, non-abbott stent was used to complete the procedure. There were no adverse patient effects and there was no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02495 |
| MDR Report Key | 9837643 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-11-19 |
| Date Added to Maude | 2020-03-16 |
| 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 | 2020-03-16 |
| Returned To Mfg | 2020-03-09 |
| Model Number | S-55-150-120-P6 |
| Catalog Number | S-55-150-120-P6 |
| Lot Number | 9111961 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2020-03-16 |