TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Report

Report Number: 2134265-2010-04360
Event Type: Injury
Date Received: September 22, 2010
Date of Event: August 27, 2010
Report Date: August 31, 2010
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

DEVICE IS COMBINATION PRODUCT. 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).

Additional Manufacturer Narrative · 1

CORRECTION: DESCRIBE EVENT OR PROBLEM.(B)(4).

Description of Event or Problem · 1

IT WAS PREVIOUSLY REPORTED THAT THE 4.0X12MM TAXUS LIBERTE STUDY STENT LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY DID NOT FULLY EXPAND DURING IMPLANTATION BUT UPDATED INFORMATION NOTED INCOMPLETE APPOSITION OF THE STUDY STENT. IT WAS NOTED THAT THE UNDER EXPANSION OF THE 3.0X12MM TAXUS LIBERTE STUDY STENT LOCATED IN THE MID LAD NECESSITATED THE ADDITIONAL 3.0X12MM TAXUS LIBERTE STUDY STENT ALSO PLACED IN THE MID LAD. THE PATIENT WAS DISCHARGED TWO DAYS POST THE INDEX PROCEDURE ON ASPIRIN AND PRASURGREL.

Description of Event or Problem · 1

(B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-04359. IT WAS REPORTED THAT DURING A CORONARY DRUG ELUTING STENTING TREATMENT PROCEDURE, THE STUDY STENT DID NOT FULLY EXPAND. THE INDEX PROCEDURE TREATED FOUR TARGET LESIONS IN A STAGED INDEX PROCEDURE. THE 1ST LESION WAS A 99% STENOSED, 4.0X20MM TARGET LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). TREATMENT USED A DIRECT STENT TECHNIQUE AND PLACED A 3.5 X 24MM TAXUS LIBERTE STENT AND UTILIZED POST-DILATATION RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND PRASUGREL. A STAGED PROCEDURE 36 DAYS LATER TREATED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE SECOND LESION WAS A 75% STENOSED, 4.0X8MM TARGET LESION LOCATED IN THE MID LAD. TREATMENT USED A DIRECT STENT TECHNIQUE AND PLACED A 3.0 X 12MM TAXUS LIBERTE STENT. POST-STENT DEPLOYMENT IVUS WAS USED WHICH NOTED STENT UNDER-EXPANSION. THIS WAS TREATED WITH POST-DILATATIONS WITH A NON-COMPLIANT BALLOON RESULTING IN 0% RESIDUAL STENOSIS. THE 3RD LESION WAS A 75% STENOSED, 3.3X8.0MM BIFURCATED TARGET LESION LOCATED IN THE MID LAD. TREATMENT USED A DIRECT STENT TECHNIQUE AND PLACED A 3.0 X 12MM TAXUS LIBERTE STENT AND UTILIZED POST-DILATATION RESULTING IN 0% RESIDUAL STENOSIS. THE 4TH LESION WAS A 75% STENOSED, 4.3X8.0MM TARGET LESION LOCATED IN THE PROXIMAL LAD ARTERY. TREATMENT USED A DIRECT STENT TECHNIQUE AND PLACED A 4.0 X 12MM TAXUS LIBERTE STENT. POST-STENT DEPLOYMENT IVUS WAS USED WHICH NOTED STENT UNDER-EXPANSION. THIS WAS TREATED WITH POST-DILATATIONS WITH A NON-COMPLIANT BALLOON RESULTING IN 0% RESIDUAL STENOSIS.

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT DURING THE STAGED PROCEDURE, POST IVUS NOTED A DISSECTION CAUSED BY THE 3.0X12MM TAXUS LIBERTE IMPLANTED IN THE BIFURCATION OF THE MID LAD, NOT INCOMPLETE APPOSITION AS PREVIOUSLY REPORTED. THE 4.0X12MM TAXUS LIBERTE STENT WAS USED TO TREAT THE DISSECTION AND WAS INCOMPLETELY APPOSED REQUIRING POST DILATION. THE PATIENT WAS DISCHARGED 1 DAY POST THE STAGED PROCEDURE ON ASPIRIN AND PRASUGREL.

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 - MAPLE GROVE	H7493893612400	13170933

Patients

Seq	Age	Sex	Outcome	Treatment
1	48 YR		Required Intervention	3.0X12 TAXUS LIBERTE\| 3.0X12 TAXUS LIBERTE