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 2020-03-16 for SUPERA PERIPHERAL STENT SYSTEM S-65-040-120-P6 manufactured by Abbott Vascular.
[183668829]
The device was returned. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[183668830]
It was reported that the procedure was performed to treat a 75% stenosed and heavily calcified lesion in the mid superficial femoral artery. A 6f sheath and a ht command 18 guide wire were advanced to the lesion. Following pre-dilatation, a 6. 5x40mm supera self-expanding stent system was advanced and an attempt to deploy the stent was performed. The thumb slide was advanced; however, the last 1cm failed to deploy despite further thumb slide advancements. The deployment lock was released; however, the stent did not fully deploy. The delivery system was pulled slowly out of the anatomy under fluoroscopy and the stent completely deployed from the system. The implanted stent seemed to be elongated by 30% at the 1cm section that deployed with the removal of the delivery system. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02502 |
| MDR Report Key | 9837791 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2019-06-18 |
| 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 | 2020-03-13 |
| Model Number | S-65-040-120-P6 |
| Catalog Number | S-65-040-120-P6 |
| Lot Number | 9061861 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 |