TAXUS® LIBERTÉ®

Report

Report Number: 2134265-2013-00885
Event Type: Injury
Date Received: February 21, 2013
Date of Event: January 12, 2013
Report Date: January 24, 2013
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS COMBINATION PRODUCT. PATIENT IDENTIFIER: (B)(6). DEVICE EVALUATION 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).

Description of Event or Problem · 1

SAME CASE AS MDR ID #2134265-2013-00876. IT WAS REPORTED THAT POST A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION. IN (B)(6) 2010, THE PATIENT PRESENTED WITH RIGHT SIDED CHEST PRESSURE AND TIGHTNESS ASSOCIATED WITH DIAPHORESIS, DYSPNEA AND FATIGUE AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 80% STENOSED AND 12MM LONG FIRST TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE FIRST TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 3.0X16MM TAXUS LIBERTE STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE 90% STENOSED AND 10MM LONG DE-NOVO SECOND TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.9MM. THE SECOND TARGET LESION WAS TREATED WITH DIRECT OVERLAPPING STENT PLACEMENT OF TWO 2.50X8MM TAXUS LIBERTE STENTS, RESULTING IN 0% RESIDUAL STENOSIS POST DILATION. THE PATIENT RETURNED THE FOLLOWING DAY FOR A STAGED STENT PLACEMENT PROCEDURE. THE 80% STENOSED AND 10MM LONG DE-NOVO THIRD TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 2.2MM. THE THIRD TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 2.25X 16MM TAXUS ATOM STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2011, THE PATIENT RECEIVED PLACEMENT OF A 2.50X18MM NON BSC STENT IN THE DISTAL RIGHT CORONARY ARTERY EXTENDING TO THE 1ST RIGHT POSTEROLATERAL BRANCH. IN (B)(6) 2013, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PAIN RADIATING TO SHOULDER AND JAW AND WAS HOSPITALIZED ON THE SAME DAY. ELECTROCARDIOGRAPHY REVEALED POSSIBLE ANTERIOR AND INFERIOR INFARCT WITH T WAVE INVERSION IN INFERIOR LEADS. THE PATIENT WAS DIAGNOSED WITH ACUTE INFERIOR WALL MYOCARDIAL INFARCTION AND CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY REVEALED A 100% TOTAL OCCLUSION OF THE NON BSC STENT IN THE DISTAL RIGHT CORONARY ARTERY EXTENDING TO THE 1ST RIGHT POSTEROLATERAL BRANCH. THE OCCLUSION WAS TREATED WITH PRE-DILATION WITH RESTORATION OF TIMI III FLOW IN THE DISTAL RIGHT CORONARY ARTERY. THE 100% TOTAL OCCLUSION OF STUDY STENTS IN RIGHT POSTERIOR DESCENDING ARTERY WERE TREATED WITH PRE-DILATATION WITH RESTORATION OF FLOW IN RIGHT POSTERIOR DESCENDING ARTERY. FOLLOWING PRE-DILATATION, RESIDUAL STENOSIS WAS 90% WHICH WAS TREATED WITH PLACEMENT OF A 2.50X8 MM NON BSC STENT, RESULTING IN 0% RESIDUAL STENOSIS. IN ADDITION TO THIS EVENT A SECOND WIRE WAS PASSED THROUGH THE PREVIOUSLY PLACED NON BSC STENT IN THE DISTAL PORTION OF 1ST RIGHT POSTEROLATERAL BRANCH AND BALLOON ANGIOPLASTY WAS PERFORMED. TWO DAYS LATER THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
77455	TAXUS® LIBERTÉ®	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - MAPLE GROVE	H749389378250	13170125

Patients

Seq	Age	Sex	Outcome	Treatment
1	61 YR		Required Intervention