FDA Adverse Event Injury Summary report: N

PROMUS ELEMENT¿ PLUS

MDR report key: 2981555 · Received February 27, 2013

Report

Report Number: 2134265-2013-00954
Event Type: Injury
Date Received: February 27, 2013
Date of Event: January 29, 2013
Report Date: January 29, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P110010
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. 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

SAME CASE AS MFR ID # 2134265-2013-00955. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, IN-STENT RESTENOSIS AND DEFORMATION OCCURRED. THE 80% STENOSED TARGET LESIONS WERE LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED LEFT MAIN AND PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERIES. THE 2.75X28MM PROMUS ELEMENT AND 2.75X24MM PROMUS ELEMENT WERE SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED. IN (B)(6) 2013, A FOLLOW-UP DIAGNOSTIC PROCEDURE REVEALED IN-STENT RESTENOSIS AND DEFORMATION OF THE IMPLANTED PROMUS ELEMENT STENTS. THE LESION WAS TREATED WITH ADDITIONAL STENT PLACEMENT. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
84377	PROMUS ELEMENT¿ PLUS	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493918428270	15219205

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Required Intervention