FDA Adverse Event
Death
Summary report: N
COMPLETE SE SFA
MDR report key: 5207023
·
Received November 6, 2015
Report
- Report Number
- 9612164-2015-01726
- Event Type
- Death
- Date Received
- November 6, 2015
- Date of Event
- October 19, 2015
- Report Date
- October 21, 2015
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIP
- PMA / PMN Number
- P110040
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE A COMPLETE SE STENT WAS IMPLANTED IN THE LEFT LEG FOR PERSISTENT RESIDUAL STENOSIS. IT IS REPORTED THAT THE PATIENT WAS DISCHARGED THE NEXT DAY. A WEEK LATER THE PHYSICIAN IMPLANTED A COMPLETE SE STENT TO TREAT A DISSECTION LOCATED IN THE SFA AND POPLITEAL OF THE RIGHT LEG. APPROXIMATELY 33 MONTHS POST INDEX PROCEDURE PATIENT DEATH OCCURRED. CAUSE OF DEATH WAS STROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 737918 | COMPLETE SE SFA | STENT, SUPERFICIAL FEMORAL ARTERY | NIP | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | Death |