FDA Adverse Event
Injury
Summary report: N
MULTI-LINK RX ZETA CORONARY STENT SYSTEM
MDR report key: 1020616
·
Received March 28, 2008
Report
- Report Number
- 2024168-2008-00230
- Event Type
- Injury
- Date Received
- March 28, 2008
- Date of Event
- February 26, 2008
- Report Date
- February 27, 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
- TU
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY- PERMANENT IMPAIRMENT. REPORTING RATIONALE: A PORTION OF THE STENT IS IN AN UNINTENDED SITE. DEVICE ISSUE: INCORRECT SIZE STENT. IT WAS REPORTED THAT AFTER INFLATION OF THE BALLOON OF THE 3.0 X 8 MM ZETA, THE STENT WAS SEEN TO BE OVERSIZED (3.0 X 20MM). THE STENT REMAINS IN THE PT. NO ADDITIONAL EVENT OR PT INFO 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 | 7112831 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Disability |