FDA Adverse Event
Injury
Summary report: N
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
MDR report key: 588624
·
Received April 5, 2005
Report
- Report Number
- 2024168-2005-00208
- Event Type
- Injury
- Date Received
- April 5, 2005
- Date of Event
- February 19, 2005
- Report Date
- March 11, 2005
- Manufacturer
- GUIDANT VANSCULAR INTERVENTION
- Product Code
- MAF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
INFORMATION RECEIVED RELATED TO A TRAIL CONDUCTED OUTSIDE OF THE UNITED STATES REPORTING THAT THE PT HAD A NON-Q MI(CK AND CK-MB ELEVATION) THREE DAYS POST-PROCEDURE, AFTER HOSPITAL DISCHARGE. THE PT WAS RE-HOSPITALIZED AND UNDERWENT RE-PTCA ON THE TARGET LESION.
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 VANSCULAR INTERVENTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |