FDA Adverse Event
Injury
Summary report: N
ACS MULTI-LINK DUET CORONARY STENT SYSTEM
MDR report key: 1293085
·
Received January 22, 2009
Report
- Report Number
- 2024168-2009-00114
- Event Type
- Injury
- Date Received
- January 22, 2009
- Date of Event
- September 12, 2008
- Report Date
- December 28, 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, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. DURING A POST MARKET CLINICAL TRIAL, IT WAS REPORTED THAT APPROXIMATELY 10 YEARS POST STENTING OF THE MID RCA WITH A DUET STENT, THERE WAS 85% RESTENOSIS NOTED WITHIN THE STENT. THE RESTENOSIS WAS TREATED WITH PLACEMENT OF A XIENCE V STENT WITHIN THE STENOSIS RESULTING IN 0% STENOSIS POST STENT PLACEMENT. NO ADDITIONAL EVENT OR PATIENT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS MULTI-LINK DUET CORONARY STENT SYSTEM | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R |