TAXUS® LIBERTÉ®

Report

Report Number: 2134265-2012-07458
Event Type: Injury
Date Received: December 10, 2012
Date of Event: November 9, 2012
Report Date: November 9, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P060008
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT 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

IT WAS REPORTED THAT FOLLOWING A STENTING TREATMENT PROCEDURE, IN-STENT RESTENOSIS OCCURRED. THE PROCEDURE TREATED THE 75% STENOSED TARGET LESION LOCATED IN THE MILDLY CALCIFIED AND MILDLY TORTUOUS LEFT ANTERIOR DESCENDING ARTERY. USING A DIRECT STENTING TECHNIQUE, A 3.0X16MM TAXUS LIBERTE STENT WAS ADVANCED AND DEPLOYED AT 14 ATMS FOR 90 SECONDS RESULTING IN 0% RESIDUAL STENOSIS. NO POST DILATION WAS PERFORMED. IN 11/2012, THE PATIENT PRESENTED WITH SUBSTERNAL CHEST PAIN AND IN-STENT RESTENOSIS WAS REVEALED WITH TIMI FLOW 0. TREATMENT CONSISTED OF PRE-DILATION WITH AN UNSPECIFIED BALLOON INFLATED TO 15 ATMS FOR 10 SECONDS AND THE PLACEMENT OF A 3.0X16MM PROMUS ELEMENT PLUS STENT DEPLOYED AT 22 ATMS FOR 45 SECONDS WITH EXCELLENT RESULT AND 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TAXUS® LIBERTÉ®	CORONARY DRUG-ELUTING STENT	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493893616300	7234686

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention