FDA Adverse Event
Other
Summary report: N
PROTEGE STENT
MDR report key: 5679513
·
Received September 21, 2004
Report
- Report Number
- 2134479-2004-00026
- Event Type
- Other
- Date Received
- September 21, 2004
- Date of Event
- July 29, 2004
- Report Date
- September 20, 2004
- Manufacturer
- EV3 INC.
- Product Code
- FGE
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
METHOD CODE: THE STENT WILL NOT RETURN FOR ANALYSIS. ATTEMPTS WERE MADE TO OBTAIN THE LOT NUMBER OF THE STENT SYSTEM, HOWEVER, THE LOT NUMBER WAS NOT DOCUMENTED ON THE PATIENT'S MEDICAL RECORDS. X-RAY COPIES WERE SENT TO THE MANUFACTURER FOR EVALUATION. ANALYSIS OF THE X-RAYS DID NOT CONFIRM THAT THE STENT(S) WERE SHORTENED. THE ACTUAL LENGTH OF THE STENT COULD NOT BE DETERMINED. PHYSICIAN DECIDED TO INTERVENE BY USING AN ADDITIONAL SYSTEM.
Description of Event or Problem · 1
THE STENT SHORTENED. THE PHYSICIAN USED A SECOND 9X40 PROTEGE AND WAS SUCCESSFUL BY OVERLAPPING THE FIRST STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROTEGE STENT | STENT SYSTEM | FGE | EV3 INC. | SERB65-09-40-80 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |