FDA Adverse Event
Death
Summary report: N
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
MDR report key: 1050194
·
Received May 22, 2008
Report
- Report Number
- 2024168-2008-00414
- Event Type
- Death
- Date Received
- May 22, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 1, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- P970020
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: DEATH. REPORTING RATIONALE: THE PATIENT EXPIRED DUE TO SLOW FLOW FOLLOWING IMPLANTATION OF THE STENT. DEVICE ISSUE: NONE. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE STENT, THERE WAS SLOW FLOW IN THE ARTERY AND THE PATIENT DIED ON THE TABLE. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK RX ZETA CORONARY STENT SYSTEM | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 8040231 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Death | GUIDE CATHETER: JL 3.5| GUIDE WIRE: ZINGER| DILATATION CATHETER: VOYAGER| SHEATH: 6 FRENCH |