MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-18 for COOK ZILVER PTX 6 MM X 40 MM STENT manufactured by Cook Medical Llc.
[180362830]
Pt had ir thrombolysis during which time a stent was advanced through the sheath and prematurely deployed. Advancement was aborted. Retrieval of the stent was successful, but 3-4 of the distal times of the stent sheared off around the left common femoral artery, likely extravascular. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093071 |
| MDR Report Key | 9728806 |
| Date Received | 2020-02-18 |
| Date of Report | 2020-02-13 |
| Date of Event | 2019-10-09 |
| Date Added to Maude | 2020-02-19 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | COOK ZILVER PTX 6 MM X 40 MM STENT |
| Generic Name | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING |
| Product Code | NIU |
| Date Received | 2020-02-18 |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK MEDICAL LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-18 |