FDA Adverse Event Malfunction Summary report: N

PROMUS ELEMENT¿ PLUS

MDR report key: 2821112 · Received November 6, 2012

Report

Report Number: 2134265-2012-07027
Event Type: Malfunction
Date Received: November 6, 2012
Date of Event: October 26, 2012
Report Date: October 29, 2012
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 THE TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED 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

IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE 2.0-2.3X11MM, ALMOST "CONCENTRIC" LESION BEING TREATED WAS LOCATED IN THE NON-CALCIFIED BIFURCATION OF THE PROXIMAL 1 DIAGONAL (1ST DX) AND LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 1ST DX LESION WAS PREDILATED WITH AN UNKNOWN 2MM SEMI-COMPLIANCE BALLOON. THE PHYSICIAN ATTEMPTED TO PLACE THE 2.25X12MM PROMUS ELEMENT PLUS STENT THROUGH THE STRUT OF THE PREVIOUSLY DEPLOYED UNKNOWN STENT, BUT COULD NOT CROSS THE LESION. UPON REMOVAL THE DISTAL EDGE OF THE STENT WAS FOUND TO BE FLARED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT¿ PLUS	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493918412220	15505136

Patients

Seq	Age	Sex	Outcome	Treatment
1