TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2010-04276
- Event Type
- Injury
- Date Received
- September 28, 2010
- Date of Event
- February 26, 2010
- Report Date
- September 6, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4).
DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER - IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
DESCRIBE EVENT AND OTHER RELEVANT HISTORY UPDATED. (B)(4).
(B)(4).
IT WAS FURTHER REPORTED THAT FOLLOW-UP CORONARY ANGIOGRAPHY PERFORMED IN (B)(6) 2010 REVEALED THE LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WAS 90% STENOSED, 3.5MM IN DIAMETER AND 30MM LONG, AND THE LESION LOCATED IN THE RIGHT ATRIOVENTRICULAR BRANCH (R-PAV) WAS 90% STENOSED, 3.0MM IN DIAMETER AND 16MM LONG. NO ISCHEMIC SYMPTOMS WAS NOTED. THE LESIONS WERE DILATED WITH A BALLOON CATHETER. POST PROCEDURE INSPECTION REVEALED 25% RESIDUAL STENOSIS LOCATED IN THE MID RCA AND 25% RESIDUAL STENOSIS LOCATED IN THE R-PAV. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT OUTCOME IMPROVED. THE PATIENT WAS DISCHARGED 3 DAYS LATER. IN (B)(6) 2010, A 1 YEAR FOLLOW-UP WAS PERFORMED WITH NO ANGINAL SYMPTOMS NOTED.
SAME CASE AS MFR.#'S: 2134265-2010-04275 AND 2144265-2010-05861. IT WAS FURTHER REPORTED THAT DURING THE INDEX PROCEDURE IN (B)(6) 2009, THE LESION LOCATED IN THE MID RCA WAS 90% STENOSED, 3.5MM IN DIAMETER AND 30MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF TWO 3.50X32MM TAXUS LIBERTE STENTS WITHOUT GAP. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE LESION LOCATED IN THE R-PAV WAS 90% STENOSED, 3.0MM IN DIAMETER AND 16MM LONG. IT WAS TREATED WITH PREDILATION AND PLACEMENT OF A 3.0X16MM TAXUS LIBERTE STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW NOTED. THE PATIENT WAS DISCHARGED 3 DAYS LATER ON ASPIRIN, CLOPIDOGREL BISULFATE AND BERAPROST SODIUM. POST INDEX PROCEDURE IN (B)(6) 2010, FOLLOW-UP CORONARY ANGIOGRAM CONFIRMED STENOSIS IN THE 1ST DIAGONAL. THE LESION LOCATED IN THE 1ST DIAGONAL WAS TREATED WITH PLACEMENT OF A NON-BSC STENT. THE EVENTS LOCATED IN THE MID RCA AND R-PAV SUBSIDED AND THE 1ST DIAGONAL WAS CONSIDERED RESOLVED. THE PATIENT WAS DISCHARGED 3 DAYS LATER.
(B)(4). SAME CASE AS: 2134265-2010-04275. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED RESTENOSIS. LESION 1 WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). DURING THE INDEX PROCEDURE, THE PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS LIBERTE STENT IN THE MID RCA. LESION 2 WAS LOCATED IN THE RIGHT ATRIOVENTRICULAR BRANCH (R-PAV). THE PHYSICIAN IMPLANTED AN UNKNOWN SIZE TAXUS LIBERTE STENT IN THE RIGHT PAV. IN (B)(6) 2010, THE PATIENT EXPERIENCED RESTENOSIS. IT WAS NOTED THAT RESTENOSIS WAS REVEALED IN THE MID RCA AND R-PAV. THE LESIONS LOCATED IN THE MID RCA AND R-PAV WERE TREATED WITH A TARGET VESSEL REINTERVENTION.
IT WAS FURTHER REPORTED THAT LESION 1 AND LESION 2 WERE DE NOVO LESIONS. THE MID RIGHT CORONARY ARTERY WAS TREATED AND TIMI FLOW GRADE REMAINED 3.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - GALWAY | UNK433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Hospitalization| R |