TAXUS¿ ELEMENT¿

Report

Report Number: 2134265-2012-07005
Event Type: Injury
Date Received: November 15, 2012
Report Date: October 22, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P100023
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). EVENT DATE: (B)(6) 2012. DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

Description of Event or Problem · 1

(B)(4). IT WAS REPORTED POST A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT IMPLANTATION STENT RESTENOSIS OCCURRED. THE SUBJECT PRESENTED DUE TO UNSTABLE ANGINA (BRAUNWALD CLASS-IIB) AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE TARGET LESION WAS A DENOVO LESION LOCATED IN THE PROXIMAL RCA (RIGHT CORONARY ARTERY). IT WAS DESCRIBED AS 4MM LONG, WITH A VESSEL DIAMETER OF 10 MM AND 95% STENOSIS. THE LESION WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF A 4.00X12MM TAXUS ELEMENT STENT WITH 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL. POST INDEX PROCEDURE, IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 100% RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT WAS TREATED WITH PCI BUT WAS UNSUCCESSFUL. THE EVENT WAS CONSIDERED NOT RECOVERED /NOT RESOLVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS¿ ELEMENT¿	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493902512400	13656849

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention