MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for EVERFLEX? EVD35-06-100-120 manufactured by Covidien.
[185225439]
Patient with claudication underwent left leg angiogram via the femoral artery for everflex stent 6x100 insertion. The stent opened up halfway, got stuck and would not deploy all the way. The md was able to trouble-shoot the deployment device by opening it up while talking to the device rep on the phone. Manufacturer response for everflex stent 6x100, (brand not provided) (per site reporter). Device sent back to manufacturer today, 3/11/2020 therefore no response.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9888556 |
| MDR Report Key | 9888556 |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-03-04 |
| Report Date | 2020-03-11 |
| Date Reported to FDA | 2020-03-11 |
| Date Reported to Mfgr | 2020-03-27 |
| Date Added to Maude | 2020-03-27 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EVERFLEX? |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY |
| Product Code | NIP |
| Date Received | 2020-03-27 |
| Model Number | EVD35-06-100-120 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 60 MIDDLETOWN AVE NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |