FDA Adverse Event Malfunction Summary report: N

PROMUS ELEMENT ¿

MDR report key: 2875195 · Received December 17, 2012

Report

Report Number: 2134265-2012-07770
Event Type: Malfunction
Date Received: December 17, 2012
Date of Event: November 26, 2012
Report Date: November 27, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS A COMBINATION PRODUCTS. (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 DAMAGE OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN MID LEFT ANTERIOR DESCENDING (LAD). PROXIMAL TO THE IMPLANTED 2.25MM PROMUS STENT WITH OVERLAPPING TO IT, THE PHYSICIAN ATTEMPTED ADVANCING A 3.5X20MM PROMUS ELEMENT PLUS STENT TO THE LESION. THE DEVICE BUMPED INTO CALCIFICATION AND WAS UNABLE TO CROSS THE LESION. PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED. THE DEVICE WAS STILL UNABLE TO CROSS THE LESION. THE PHYSICIAN REMOVED THE DEVICE OUTSIDE THE PATIENT'S BODY AND STENT DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT ¿	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911320350	15258803

Patients

Seq	Age	Sex	Outcome	Treatment
1