FDA Adverse Event
Injury
Summary report: N
MULTI-LINK RX VISION CORONARY STENT SYSTEM
MDR report key: 681326
·
Received March 1, 2006
Report
- Report Number
- 2024168-2006-00170
- Event Type
- Injury
- Date Received
- March 1, 2006
- Date of Event
- January 27, 2006
- Report Date
- February 7, 2006
- Manufacturer
- GUIDANT VASCULAR INTERVENTION
- Product Code
- MAF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT SAT OF THE STENTS (VISION 3.0X18MM AND VISIION 3.0X8MM) OCCURRED FIVE DAYS AFTER IMPLANTATION. THE SAT WAS TREATED WITH A THROMBUS SUCTION CATHETER AND AN ADDITIONAL STENT WAS IMPLANTED.
Description of Event or Problem · 1
SAT OF THE STENT OCCURRED FIVE DAYS AFTER THE DATE OF IMPLANT. THE SAT WAS TREATED WITH A THROMBUS SUCTION CATHETER AND AN ADDITIONAL STENT WAS IMPLANTED. NO OTHER INFO WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK RX VISION CORONARY STENT SYSTEM | CORONARY STENT SYSTEM | MAF | GUIDANT VASCULAR INTERVENTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |