FDA Adverse Event Death Summary report: N

PROMUS ELEMENT? PLUS

MDR report key: 3950959 · Received July 22, 2014

Report

Report Number: 2134265-2014-04269
Event Type: Death
Date Received: July 22, 2014
Date of Event: January 20, 2014
Report Date: June 26, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P110010
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

Description of Event or Problem · 1

(B)(4). SAME CASE AS MFR ID # 2134265-2014-04268. IT WAS REPORTED THAT FOLLOWING A PERCUTANEOUS CORONARY INTERVENTION, THE PATIENT EXPIRED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH STABLE ANGINA. THE 2.5X30MM, 90% STENOSED, ECCENTRICALLY SHAPED, DE NOVO, TYPE C TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED PROXIMAL CIRCUMFLEX (LCX) ARTERY. THE LESION WAS PRE-DILATED AND THE 2.25X32MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED AT 12 ATMS. THE DEPLOYED STENT WAS POST-DILATED RESULTING IN TIMI 3 FLOW AND 0% RESIDUAL STENOSIS. IT WAS ALSO NOTED ANOTHER UNKNOWN PROMUS ELEMENT STENT WAS DEPLOYED DURING THE SAME PROCEDURE. THE PATIENT WAS DISCHARGED TWO DAYS LATER ON ASPIRIN AND PLAVIX. IN (B)(6) 2014, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
429133	PROMUS ELEMENT? PLUS	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493918432220

Patients

Seq	Age	Sex	Outcome	Treatment
1	54 YR		Death