TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2010-05707
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- May 12, 2009
- Report Date
- November 26, 2010
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P030025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
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).
(B)(4).
(B)(4). SAME CASE AS 2134265-2010-05707. SAME PATIENT AS 2134265-2010-00659. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED ANGINA. THE TARGET LESION LOCATED IN DISTAL RIGHT CORONARY ARTERY (RCA) WITH REFERENCE VESSEL DIAMETER OF 3.00 MM, LENGTH OF 32.0 MM, AND 75% STENOSIS. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION, AND IMPLANTING A 3.00X32 MM TAXUS EXPRESS2 STUDY STENT, AND POST-DILATATION. RESIDUAL STENOSIS BECAME 0% . TIMI FLOW INCREASED FROM 2 TO 3. THE PATIENT WAS DISCHARGED ON TICLOPIDINE AND BAYASPIRIN. IN (B)(6) 2008, THE PATIENT EXPERIENCED IN-STENT RESTENOSIS IN THE PROXIMAL AND MID RIGHT CORONARY ARTERY WHICH WAS TREATED WITH A TAXUS STENT. IN (B)(6) 2009 THE PATIENT EXPERIENCED ANGINA. THIS WAS TREATED WITH BALLOON ANGIOPLASTY. IN (B)(6) 2009 THE PATIENT ONCE AGAIN EXPERIENCED ANGINA. THE LESIONS WERE DILATED WITH A BALLOON CATHETER OF UNKNOWN SIZE AND TYPE. IN (B)(6) 2009 THE PATIENT AGAIN EXPERIENCED ANGINA AND CORONARY ARTERY BYPASS GRAFTING FOR THE DISTAL RIGHT CORONARY ARTERY WAS PERFORMED. THE PATIENT'S ANGINA IMPROVED. THE PATIENT HAD NO ANGINA SYMPTOMS AT THE 2 YEAR FOLLOW-UP.
IT WAS FURTHER REPORTED THAT IN (B)(6) 2008, RESTENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND IN THE MID RCA WERE CONFIRMED, AND PCI WAS PERFORMED. IN (B)(6) 2009, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. THE LESION IN THE MID RCA WAS 99% STENOSED WITH A REFERENCE VESSEL DIAMETER OF 3.0MM AND A LENGTH OF 15.0MM. THE LESION WAS TREATED WITH BALLOON ANGIOPLASTY. RESIDUAL STENOSIS BECAME 0% AND TIMI-3 FLOW WAS MAINTAINED THROUGHOUT THE PROCEDURE. THE LESION LOCATED IN THE DISTAL RCA WAS 99% STENOSED, WITH A REFERENCE VESSEL DIAMETER OF 3.0MM AND A LENGTH OF 15.0MM, AND WAS TREATED WITH BALLOON ANGIOPLASTY. RESIDUAL STENOSIS BECAME 0%. TIMI-3 FLOW KEPT THROUGH THE PROCEDURE. THE PATIENT WAS DISCHARGED. THE INVESTIGATOR REPORTED THAT THE PCI FOR THE MID RCA WAS FOR STENOSIS CAUSED BY A NON BSC STENT PLACED PRIOR TO THE INDEX PROCEDURE. IN (B)(6) 2009, THE PATIENT AGAIN EXPERIENCED UNSTABLE ANGINA AND PCI TARGETING THE PROXIMAL RCA, MID RCA AND DISTAL RCA WAS PERFORMED. THE LESION LOCATED IN THE PROXIMAL RCA WAS 75% STENOSED WITH A REFERENCE VESSEL DIAMETER OF 3.5MM AND A LENGTH OF 14.0MM AND WAS TREATED WITH BALLOON ANGIOPLASTY. RESIDUAL STENOSIS BECAME 25%. THE LESION LOCATED IN THE MID RCA WITH A REFERENCE VESSEL DIAMETER OF 3.5MM, A LENGTH OF 10.0MM AND 90% STENOSIS WAS TREATED WITH POBA. RESIDUAL STENOSIS BECAME 25%.THE LESION LOCATED IN THE DISTAL RCA WITH A REFERENCE VESSEL DIAMETER OF 3.0MM, A LENGTH OF 5.0MM AND 90% STENOSIS WAS TREATED WITH POBA. RESIDUAL STENOSIS BECAME 25%. TIMI-3 FLOW WAS MAINTAINED THROUGHOUT THE PROCEDURE. THE PATIENT WAS DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM | CORONARY DRUG-ELUTING STENT | NIQ | BOSTON SCIENTIFIC - GALWAY | UNK432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | 3.00X32MM TAXUS EXPRESS2 STENT |