MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-17 for SUPERA PERIPHERAL STENT SYSTEM S-60-150-120-P6 manufactured by Abbott Vascular.
[186734612]
Dates of event and implant: estimated dates. The device was not returned for analysis as the stent remains in the patient. The lot history record (lhr) for this product 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. The reported patient effect of restenosis is listed in the supera instructions for use as a known potential patient effect. Based on the reported information, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. The surgical procedure was related to case circumstances. There is no indication of a product quality issue with respect to manufacture, design or labeling. Literature attachment: pathology and multimodality imaging of acute and chronic femoral stenting in humans. The other supera referenced in the article as case six is being filed under a separate medwatch report number.
Patient Sequence No: 1, Text Type: N, H10
[186734613]
It was reported that the 6. 0x150 mm supera stent was implanted in the superficial femoral artery. 385 days after the stent procedure, the patient had in-stent restenosis. This supera stent was obtained after an autopsy. This was a patient referenced as case 10 in the article titled, pathology and multimodality imaging of acute and chronic femoral stenting in humans.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02518 |
| MDR Report Key | 9842444 |
| Report Source | LITERATURE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-17 |
| Date of Event | 2019-07-03 |
| Date Mfgr Received | 2020-02-25 |
| 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-60-150-120-P6 |
| Catalog Number | S-60-150-120-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 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-17 |