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 2020-03-20 for SUPERA PERIPHERAL STENT SYSTEM S-50-120-120-P6 manufactured by Abbott Vascular.
[187412324]
(b)(4). The customer reported the device is not returning. 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
[187412325]
It was reported that the procedure was performed to treat a lesion in the severely calcified right superficial femoral artery (sfa). Pre-dilatation was performed. The 5. 0 x 120 mm supera stent was implanted. The stent was fully deployed; however, after deployment, the proximal stent recoiled and seemed to twist. The stent delivery system could not be removed. The physician chose to remove the stent delivery system with resistance, rather than send the patient to surgery. The nose cone of the supera stent delivery system separated from the device; however, the stent delivery system was able to be removed. A stenotic area was created, where the stent recoil and twisting occurred. Additional balloon dilatation was performed and the stent was opened. A second 5. 0 x 80 mm supera stent was implanted at the proximal stent. A snare device was able to remove the separated nose cone. The procedure ended with all vessels and stents widely patent, and the nose cone removed from the patient. Post procedure, the patient was in stable condition. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02738 |
| MDR Report Key | 9861761 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-11-14 |
| Date Added to Maude | 2020-03-20 |
| 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 | 2020-03-20 |
| Model Number | S-50-120-120-P6 |
| Catalog Number | S-50-120-120-P6 |
| Lot Number | 9111461 |
| 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 | 1. Required No Informationntervention | 2020-03-20 |