MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-13 for ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM 7.0X100X135 1012532-100 manufactured by Abbott Vascular.
[183914251]
Stent did not deploy properly, physician was going to remove, he was unable to remove as the stent ruts and platform caught of plaque. Leg had a large amount of plaque. Vascular surgeon came and removed the stent from the illiac bifurcation. Cut down was done in order to retrieve the stent.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093763 |
| MDR Report Key | 9834868 |
| Date Received | 2020-03-13 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-02-06 |
| Date Added to Maude | 2020-03-16 |
| 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 | ABSOLUTE PRO VASCULAR SELF EXPANDING STENT SYSTEM |
| Generic Name | STENT, ILIAC |
| Product Code | NIO |
| Date Received | 2020-03-13 |
| Returned To Mfg | 2020-02-06 |
| Model Number | 7.0X100X135 |
| Catalog Number | 1012532-100 |
| Lot Number | 7060161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-13 |