FDA Adverse Event Injury Summary report: N

PROMUS ELEMENT ¿

MDR report key: 3051258 · Received April 10, 2013

Report

Report Number: 2134265-2013-02405
Event Type: Injury
Date Received: April 10, 2013
Date of Event: December 5, 2012
Report Date: March 15, 2013
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT. 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

SAME CASE AS MDR ID: 2134265-2013-02406. (B)(6) CLINICAL TRIAL. IT WAS REPORTED THAT FOLLOWING A CORONARY ARTERY DRUG ELUTING STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED UNSTABLE ANGINA. IN (B)(6) 2012, THE INDEX PROCEDURE TREATED A 90% STENOSED, 65 X 3.0MM LESION OF THE LEFT MAIN CORONARY ARTERY EXTENDING UP TO THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. TREATMENT CONSISTED OF PREDILATION AND PLACEMENT OF A 2.75 X 38 MM AND 3.50 X 28MM PROMUS ELEMENT STUDY STENTS RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL TWO DAYS AFTER. SIX DAYS POST INDEX PROCEDURE, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN AND WAS TREATED WITH MEDICATION. THE EVENT WAS RESOLVED AND THE SUBJECT WAS DISCHARGED SEVEN DAYS AFTER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
153378	PROMUS ELEMENT ¿	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911328350	15276341

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Hospitalization