FDA Adverse Event
Injury
Summary report: N
ACS (ADVANCED CARDIOVASCULAR SYSTEMS INC)
MDR report key: 195840
·
Received November 5, 1998
Report
- Report Number
- 195840
- Event Type
- Injury
- Date Received
- November 5, 1998
- Date of Event
- October 26, 1998
- Report Date
- November 3, 1998
- Manufacturer
- ADVANCED CARDIOVASCULAR SYSTEMS INC
- Product Code
- MAF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
DURING ANGIOPLASTY PROCEDURE THE INTERCORONARY STENT BECAME DISLODGED FROM THE DELIVERY BALLOON. THE STENT WAS NEVER LOCATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS (ADVANCED CARDIOVASCULAR SYSTEMS INC) Implant | CORONARY STENT | MAF | ADVANCED CARDIOVASCULAR SYSTEMS INC | ACS RX MULTI-LINK HP3.5X15 | 8022451 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization |