FDA Adverse Event
Death
Summary report: N
ANCURE ENDOGRAFT SYSTEM
MDR report key: 425892
·
Received November 1, 2002
Report
- Report Number
- 2954310-2002-00242
- Event Type
- Death
- Date Received
- November 1, 2002
- Date of Event
- June 23, 2002
- Report Date
- October 2, 2002
- Manufacturer
- GUIDANT ENDOVASCULAR SOLUTIONS
- Product Code
- MIH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
EVENT: PT DEATH. IT WAS REPORTED TO GUIDANT ON 10/02/2002 THAT A PT IMPLANTED IN 2002 EXPIRED 3 DAYS POST IMPLANT FROM BOWEL ISCHEMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANCURE ENDOGRAFT SYSTEM | ENDOVASCULAR GRAFT SYSTEM | MIH | GUIDANT ENDOVASCULAR SOLUTIONS | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |