FDA Adverse Event Malfunction Summary report: N

PROMUS ELEMENT¿ PLUS

MDR report key: 2760256 · Received September 26, 2012

Report

Report Number: 2134265-2012-05951
Event Type: Malfunction
Date Received: September 26, 2012
Date of Event: August 27, 2012
Report Date: August 29, 2012
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: NIQ
PMA / PMN Number: P110010
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCT.(B)(4).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

IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, STENT DISLODGEMENT OCCURRED. WHILE TRYING TO PLACE THE 2.50 MM X 8 MM PROMUS ELEMENT PLUS STENT IN THE PATIENT'S CIRCUMFLEX ARTERY (CX), THE DEVICE WOULD NOT CROSS. THE CX HAD A VERY ANGULATED TAKE-OFF FROM THE LEFT MAIN CORONARY ARTERY. AFTER MULTIPLE PRE-DILATATIONS AND ATTEMPTS TO CROSS THE LESION, THE PHYSICIAN PULLED THE STENT SYSTEM BACK AND FOUND THERE WAS NO STENT ON THE DELIVERY BALLOON. THE STENT WAS DISLODGED INSIDE THE GUIDE CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED WITH BALLOON DILATATION ONLY WITH NO STENT PLACEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT¿ PLUS	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - MAPLE GROVE	H7493911408250	14891543

Patients

Seq	Age	Sex	Outcome	Treatment
1