FDA Adverse Event
Injury
Summary report: N
AVE GFX OTW CORONARY STENT SYSTEM
MDR report key: 220611
·
Received April 27, 1999
Report
- Report Number
- 2953200-1999-00041
- Event Type
- Injury
- Date Received
- April 27, 1999
- Date of Event
- March 18, 1999
- Report Date
- April 5, 1999
- Manufacturer
- ARTERIAL VASCULAR ENGINEERING, INC.
- Product Code
- MAF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Description of Event or Problem · 1
A 3.0MM DIAMTER X 8MM LENGTH AVE GFX STENT WAS INSERTED INTO THE LEFT CIRCUMFLEX CORONARY ARTERY AFTER PLACEMENT OF ANOTHER MFR'S STENT AND PREDILATION WITH A PTCA BALLOON. DURING ATTEMPTS TO INSERT THE AVE GFX STENT, THE STENT WAS DISLODGED FROM THE STENT DELIVERY SYSTEM BALLOON. IT IS NOT KNOWN IF THE AVE STENT WAS PLACED THROUGH THE PREVIOUSLY DEPLOYED STENT OR IF INSTRUCTIONS FOR REMOVAL OF AN UNDEPLOYED STENT WERE FOLLOWED. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT WITH A PTCA BALLOON, BUT THE STENT DISLODGED, AGAIN, AT THE ILIO-FEMORAL ARTERY AND REMAINS WITHIN THE PT. THERE WAS NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT AND NO FURTHER INFO IS AVAILABLE FROM THE USER FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AVE GFX OTW CORONARY STENT SYSTEM Implant | OVER-THE WIRE CORONARY STENT SYSTEM | MAF | ARTERIAL VASCULAR ENGINEERING, INC. | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |