FDA Adverse Event Death Summary report: N

PROMUS ELEMENT ?

MDR report key: 4090326 · Received September 15, 2014

Report

Report Number: 2134265-2014-05435
Event Type: Death
Date Received: September 15, 2014
Date of Event: January 1, 2014
Report Date: August 20, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT DEATH OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH ASYMPTOMATIC ISCHEMIA AND PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED. THE TARGET LESION WAS A NEW, TYPE B2, ECCENTRIC LESION LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS OSTIAL OF THE RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSIS CONTAINED IN OVER 45 AND BELOW 90 DEGREE BEND AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. IT WAS TREATED WITH PREDILATATION AND PLACEMENT OF A 3.50X20MM PROMUS ELEMENT ¿ DRUG ELUTING STENT AT 18 ATMOSPHERES. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW III. THE PATIENT WAS DISCHARGED TWO DAYS POST PROCEDURE. IN (B)(6) 2014, THE PATIENT PRESENTED DUE TO CEREBROVASCULAR DAMAGE AND EXPIRED ON THE SAME DAY. THE CAUSE OF DEATH WAS NOT KNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
568454	PROMUS ELEMENT ?	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911320350

Patients

Seq	Age	Sex	Outcome	Treatment
1	74 YR		Death