FDA Adverse Event
Injury
Summary report: N
MULTI-LINK VISION RX CORONARY STENT SYSTEM
MDR report key: 635011
·
Received September 14, 2005
Report
- Report Number
- 2024168-2005-00395
- Event Type
- Injury
- Date Received
- September 14, 2005
- Date of Event
- May 13, 2005
- Report Date
- August 18, 2005
- Manufacturer
- GUIDANT VASCULAR INTERVENTION
- Product Code
- MAF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT RECURRENT ISCHEMIA HAD OCCURRED. THE PROCEDURE WAS FOR A TRIPLE CABG BECAUSE OF RESTENOSIS ON THE TARGET LESION AND OTHER CORONARY ARTERIES REALIZED IN 2005, (85 DAYS AFTER INCLUSION 02/2005). SURGICAL INTERVENTION WAS REQUIRED IN ORDER TO PREVENT IMPAIRMENT/DAMAGE. THE PROCEDURE WAS REPORTED TO BE SUCCESSFUL. NO ADD'L INFO WAS AVAIABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK VISION RX CORONARY STENT SYSTEM | CORONARY STENT SYSTEM | MAF | GUIDANT VASCULAR INTERVENTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |