FDA Adverse Event
Injury
Summary report: N
MULTI-LINK RX PENTA CORONARY STENT SYSTEM
MDR report key: 543091
·
Received September 9, 2004
Report
- Report Number
- 2024168-2004-00335
- Event Type
- Injury
- Date Received
- September 9, 2004
- Date of Event
- August 3, 2004
- Report Date
- August 13, 2004
- Manufacturer
- GUIDANT VASCULAR INTERVENTION CARDIOVASCULAR SYSTE
- 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 THE PENTA STENT WAS IMPLANTED AT THE DISTAL LCX IN 2004: THE 75% STENOSIS BECAME 0% AND THE PROCEDURE WAS CLOSED. AFTER APPROXIMATELY FOUR MONTHS, A CKG CHANGE WAS NOTED BUT NO SYMPTOMS WERE OBSERVED. 6 MONTHS LATER, CAG WAS PERFORMED AND A TOTAL OCCLUSION WAS NOTED IN THE STENT. PTCA WAS PERFORMED TO TREAT THE RESTENOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK RX PENTA CORONARY STENT SYSTEM | CORONARY STENT SYSTEM | MAF | GUIDANT VASCULAR INTERVENTION CARDIOVASCULAR SYSTE | NA | 3112532 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |