FDA Adverse Event Injury Summary report: N

NG PROMUS

MDR report key: 2920016 · Received January 17, 2013

Report

Report Number: 2134265-2013-00300
Event Type: Injury
Date Received: January 17, 2013
Date of Event: November 21, 2012
Report Date: December 21, 2012
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P110010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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. 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

(B)(4). CLINICAL STUDY. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, SIDE BRANCH STENOSIS INCREASED. THE PATIENT PRESENTED WITH STABLE ANGINA AND CARDIAC CATHETERIZATION WAS RECOMMENDED. THE 95% STENOSED, 9MM X 2.5MM TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5 X 12 MM NG PROMUS STENT WITH 0% RESIDUAL STENOSIS. ANGIO FILMS NOTED THAT THE 1ST DIAGONAL HAD A PRE-PROCEDURE PERCENT STENOSIS OF 20% AND A POST-PROCEDURE PERCENT STENOSIS OF 70%. NO ADDITIONAL TREATMENTS WERE PERFORMED. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND CLOPIDOGREL WITH NO SYMPTOMS OF ANGINA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26984	NG PROMUS	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - MAPLE GROVE	H7493925012250	15489896

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Other