FDA Adverse Event
Death
Summary report: N
COMPLETE SE SFA - IDE
MDR report key: 2829530
·
Received November 13, 2012
Report
- Report Number
- 9612164-2012-01645
- Event Type
- Death
- Date Received
- November 13, 2012
- Date of Event
- April 28, 2012
- Report Date
- November 19, 2012
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- FGE
- PMA / PMN Number
- P090006
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULTS: INHERENT RISK OF PROCEDURE (DEATH). (B)(4). EVENT DATE IS YEAR VALID ONLY.
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE THE PATIENT HAD A COMPLETE SE SFA IDE STENT IMPLANTED IN THE SFA. PATIENT DEATH IS REPORTED TO HAVE OCCURRED APPROXIMATELY 36 MONTHS POST INDEX PROCEDURE. THE INVESTIGATOR DID NOT ASSESS THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICE. PLEASE NOTE COMPLETE SE SFA IS NOT APPROVED IN THE UNITED STATES HOWEVER IT IS CONSIDERED SIMILAR TO COMPLETE SE ILIAC
Description of Event or Problem · 1
PATIENT EXPIRED APPROXIMATELY 30 MONTHS POST INDEX PROCEDURE. CAUSE OF DEATH WAS ASSESSED AS DUE TO LUNG CANCER. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COMPLETE SE SFA - IDE | CATHETER, BILIARY, DIAGNOSTIC | FGE | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Death |