FDA Adverse Event
Death
Summary report: N
ACS MULTI-LINK DUET CORONARY STENT SYSTEM
MDR report key: 220949
·
Received April 27, 1999
Report
- Report Number
- 2024168-1999-00144
- Event Type
- Death
- Date Received
- April 27, 1999
- Report Date
- March 29, 1999
- Manufacturer
- GUIDANT VASCULAR INTERVENTION
- Product Code
- MAF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PTCA/STENT, THE STENT WAS PLACED IN A MID LEFT ANTERIOR DESCENDING LESION WITHOUT INCIDENT. THE PT RETURNED TO THE CATH LAB ABOUT 1 HR LATER COMPLAINING OF CHEST PAIN. FURTHER ANGIOGRAM REVEALED THROMBUS AT THE STENT'S LOCATION. THE PT BECAME UNSTABLE AND EXPIRED AFTER UNSUCCESSFUL LIFE SAVING MEASURES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS MULTI-LINK DUET CORONARY STENT SYSTEM Implant | CORONARY STENT SYSTEM | MAF | GUIDANT VASCULAR INTERVENTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death |