FDA Adverse Event
Death
Summary report: N
MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)
MDR report key: 433804
·
Received December 20, 2002
Report
- Report Number
- 2953200-2002-01020
- Event Type
- Death
- Date Received
- December 20, 2002
- Report Date
- November 25, 2002
- Manufacturer
- MEDTRONIC AVE PERIPHERAL DIVISION
- Product Code
- MIH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AN ANEURX BIFURCATED STENT GRAFT OF UNKNOWN SIZE AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 2002. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. THE PT HAS A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE. NO PROBLEMS WERE NOTED DURING THE IMPLANT PROCEDURE. IT WAS REPORTED THAT THE PT SHOWED SYMPTOMS OF DISSEMINATED INTRAVASCULAR COAGULOPATHY (DIC) APPROX 6 HOURS POST-OPERATIVELY. THE PT RECEIVED BLOOD TRANSFUSIONS; HOWEVER, THE PT'S CONDITION DID NOT IMPROVE. THE PT DIED ON AN UNKNOWN DATE. THE CAUSE OF THE DIC IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) | AAA STENT GRAFT | MIH | MEDTRONIC AVE PERIPHERAL DIVISION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |