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 42055200-080 manufactured by Abbott Vascular.
[183535945]
The stent 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. The other supera is being filed under a separate medwatch report #. The additional device is being filed under a separate medwatch report#.
Patient Sequence No: 1, Text Type: N, H10
[183535946]
It was reported that the procedure was performed to treat a superficial femoral artery (sfa). About 4 months ago, the patient had a non-abbott stent implanted which was massively over dilated to 7mm. The ends had crimped slightly, and the stent became occluded. On (b)(6) 2020, the vessel was prepared using a 6-french non-abbott atherectomy device and a 5. 5x200mm armada 18 balloon. During deployment of the 5. 5x200mm supera stent, the stent became damaged (assumed to be invaginated) as it reached the previously implanted stent. The physician stopped the deployment and pulled back slightly to allow the stent to get back to normal but was unsuccessful as the stent became stuck with the sheath. After some pulling, the stent fully deployed. The stent was noted to be short and therefore a second same size supera stent was deployed overlapping the first supera stent in the proximal sfa. Images of the section of the damaged stent did not look great and was treated with post-plasty however it remained the same. Blood flow was brisk but within 24 hours, both supera stents had occluded. An above knee bypass procedure was done on (b)(6) 2020. Only the damaged supera stent (the first implanted) was explanted and it was then confirmed that the stent was twisted on itself and completely distorted in certain areas and not invaginated as previously thought. There was no adverse patient sequela reported. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02455 |
| MDR Report Key | 9835538 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-16 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2019-08-08 |
| 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 |
| Catalog Number | 42055200-080 |
| Lot Number | 9080861 |
| 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 | 6 | 1. Hospitalization; 2. Required No Informationntervention; 3. Deathisabilit | 2020-03-16 |