FDA Adverse Event
Death
Summary report: N
PROTEGE
MDR report key: 400059
·
Received June 17, 2002
Report
- Report Number
- 2134479-2002-00002
- Event Type
- Death
- Date Received
- June 17, 2002
- Date of Event
- May 21, 2002
- Report Date
- June 10, 2002
- Manufacturer
- SULZER INTRATHERAPEUTICS INC.
- Product Code
- FGE
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PHYSICIAN REPORTS THAT WHEN HE ATTEMPTED TO STENT A SUBCLAVICAL STENOSIS FROM THE ARM, THE STENT JUMPED FORWARD PARTIALLY INTO THE THORACIC AORTA. HE SAID THAT HE DEPLOYED A SMART STENT TO TACK THE PROTEGE DOWN BECAUSE HE WAS WORRIED THAT IT MIGHT SLIP FURTHER INTO THE AORTA. IT APPEARED THAT THE PT HAD DONE WELL DURING AND IMMEDIATELY AFTER THE PROCEDURE, BUT EXPIRED WITHIN THE NEXT DAY OR TWO. THE PHYSICIAN HAS NO KNOWLEDGE AT THIS TIME, THAT PT'S DEATH WAS RELATED TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEGE | PERIPHERAL STENT | FGE | SULZER INTRATHERAPEUTICS INC. | SE7-8-40-80 | MF2414 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death | SMART STENT (2002 TO 2002). |