FDA Adverse Event
Injury
Summary report: N
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
MDR report key: 644518
·
Received November 1, 2005
Report
- Report Number
- 2024168-2005-00464
- Event Type
- Injury
- Date Received
- November 1, 2005
- Date of Event
- June 20, 2005
- Report Date
- October 31, 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 THE PT UNDERWENT ANGIOPLASTY BECAUSE OF RESTENOSIS ON THE TARGET LESION FOUR MONTHS AFTER THE ORIGINAL STENT IMPLANT DATE OF 02/07/2005. THE PROCEDURE WAS SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM | CORONARY STENT SYSTEM | MAF | GUIDANT VASCULAR INTERVENTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |