FDA Adverse Event Malfunction Summary report: N

PROMUS PREMIER?

MDR report key: 4260126 · Received November 18, 2014

Report

Report Number: 2134265-2014-06957
Event Type: Malfunction
Date Received: November 18, 2014
Date of Event: August 25, 2014
Report Date: October 24, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P110010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT. (B)(4). THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS POSTERIOR DESCENDING ARTERY OF THE RIGHT CORONARY ARTERY (RCA) AND ATRIOVENTRICULAR (AV) OF THE RCA. AFTER PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED WITH A NON-BSC BALLOON CATHETER FOR TEN TIMES, A 16 X 2.25 PROMUS PREMIER¿ STENT FAILED TO CROSS THE LESION. PARALLEL WIRE TECHNIQUE WAS USED BUT THE ISSUE WAS NOT RESOLVED. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND UPON INSPECTION, IT WAS NOTED THAT THE DISTAL STENT STRUT WAS FOUND TO BE TURNED UP. THE PROCEDURE WAS COMPLETED WITH A NON-BSC BALLOON CATHETER WITHOUT STENTING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
746661	PROMUS PREMIER?	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493925116220	17084235

Patients

Seq	Age	Sex	Outcome	Treatment
1