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 2020-03-17 for SUPERA PERIPHERAL STENT SYSTEM S-45-120-120-P6 manufactured by Abbott Vascular.
[183823448]
The device was not returned for evaluation. The lot history record (lhr) 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. Based on the information provided, a conclusive cause for the reported difficulty could not be determined. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. Na
Patient Sequence No: 1, Text Type: N, H10
[183823449]
It was reported that the procedure was to treat a lesion in the right popliteal artery. A 4. 5x120mm supera self expanding stent system (sess) was advanced to the lesion. After deploying the stent, the physician pulled back the delivery system and the stent pulled back into the 6 french sheath. Both were removed from the anatomy and another supera was successfully implanted to complete the procedure. There was no adverse patient effect or clinically significant delay in procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02537 |
| MDR Report Key | 9842803 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-24 |
| Date Mfgr Received | 2020-02-24 |
| Date Added to Maude | 2020-03-17 |
| 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 | 2020-03-17 |
| Model Number | S-45-120-120-P6 |
| Catalog Number | S-45-120-120-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 | 6 | 2020-03-17 |