FDA Adverse Event
Injury
Summary report: N
MULTI-LINK RX VISION CORONARY STENT SYSTEM
MDR report key: 1626184
·
Received March 8, 2010
Report
- Report Number
- 2024168-2010-00444
- Event Type
- Injury
- Date Received
- March 8, 2010
- Date of Event
- February 12, 2010
- Report Date
- February 12, 2010
- Manufacturer
- ABBOTT VASCULAR CLONMEL
- Product Code
- MAF
- PMA / PMN Number
- P020047
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4). THE 2.0 X 12 MM VOYAGER (PART 1011392-12, LOT 9121563), HAS BEEN FILED UNDER MFR# 2024168-2010-00443. THE 3.5 23 MM VISION (PART 1007843-23, LOT 9011441), INDICATED IS BEING FILED UNDER THE SAME MFR#.
Description of Event or Problem · 1
DEVICE ISSUE: NONE. ADVERSE EVENT: RESTENOSIS. ONSET OF ADVERSE EVENT: AFTER THE PROCEDURE. THE PROCEDURE WAS TO TREAT IN-STENT RESTENOSIS OF TWO VISIONS (3.5X15 AND 3.5X23) IMPLANTED ON (B) (6) 2009, IN THE OSTIAL AND PROXIMAL RCA. THE BALLOON DILATATION CATHETER WAS TAKEN TO THE OSTIAL LESION, INFLATED TO 18 ATMOSPHERES AND IT BURST. A 2.5 X 12 VOYAGER WAS THEN USED AND COMPLETED THE PROCEDURE SUCCESSFULLY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MULTI-LINK RX VISION CORONARY STENT SYSTEM | MAF | ABBOTT VASCULAR CLONMEL | NA | 9042242 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization| R | DILATATION CATHETER: 2.0 X 12 MM VOYAGER,| LOT 9011441).| STENT: 3.5 23 MM VISION (PART 1007843-23,| (PART 1011392-12, LOT 9121563) |