FDA Adverse Event
Injury
Summary report: N
MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM
MDR report key: 1033850
·
Received April 25, 2008
Report
- Report Number
- 2024168-2008-00354
- Event Type
- Injury
- Date Received
- April 25, 2008
- Date of Event
- March 21, 2008
- Report Date
- March 26, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- MAF
- PMA / PMN Number
- PO20047
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: STENT DISLODGEMENT REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: STENT DISLODGEMENT. IT WAS REPORTED THAT A 3.0X12 MM VISION WOULD NOT CROSS A LESION IN THE LAD. THE 2.5X28 MINI-VISION WOULD NOT CROSS A HEAVILY CALCIFIED LESION IN THE CIRCUMFLEX. AFTER REPEATED ATTEMPTS TO CROSS THE LESION, WITH FORCE APPLIED AGAINST RESISTANCE, THE STENT DISLODGED IN THE CORONARY. THE DISLODGED STENT WAS SNARED WITH NO DIFFICULTY. NO ADD'L EVENT OR PT INFO IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK MINI VISION RX CORONARY STENT SYSTEM | 74MAF | MAF | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 7102631 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | UK |