FDA Adverse Event Injury Summary report: N

OMEGA¿

MDR report key: 2962258 · Received February 14, 2013

Report

Report Number: 2134265-2013-00916
Event Type: Injury
Date Received: February 14, 2013
Date of Event: January 18, 2013
Report Date: January 18, 2013
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: MAF
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MFR: 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 DURING A CORONARY STENTING TREATMENT PROCEDURE THE STENT DISLODGED FROM THE BALLOON. THE 20MM IN LENGTH, 2.50MM IN DIAMETER, CONCENTRIC, DE NOVO AND 70% STENOSED TARGET LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH AN UNSPECIFIED BALLOON. A 2.50X20MM OMEGA STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE RCA. THE STENT SHIFTED AND DISLODGED FROM THE SDS, HOWEVER, THE STENT WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
64982	OMEGA¿	STENT, CORONARY	MAF	BOSTON SCIENTIFIC - MAPLE GROVE	H7493913820250	15249806

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention