FDA Adverse Event Injury Summary report: N

PROMUS ELEMENT¿ PLUS

MDR report key: 2882429 · Received December 20, 2012

Report

Report Number: 2134265-2012-08051
Event Type: Injury
Date Received: December 20, 2012
Date of Event: November 29, 2012
Report Date: December 3, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P110010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). 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

(B)(4) STUDY. IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE, PLAQUE SHIFT OCCURRED. THE TARGET LESION WAS A DE-NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH 80% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 20 MM PROMUS ELEMENT PLUS STUDY STENT. FOLLOWING THE PLACEMENT OF THE STUDY STENT, PLAQUE SHIFT INTO THE DIAGONAL BRANCH WAS NOTED WHICH WAS TREATED WITH BALLOON ANGIOPLASTY REDUCING STENOSIS FROM 90% TO 20%. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT¿ PLUS	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911420250	15460884

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention