FDA Adverse Event Injury Summary report: N

PROMUS ELEMENT ¿

MDR report key: 2761176 · Received September 26, 2012

Report

Report Number: 2134265-2012-05916
Event Type: Injury
Date Received: September 26, 2012
Date of Event: June 19, 2012
Report Date: August 31, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS COMBINATION PRODUCT. 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 STENTING TREATMENT PROCEDURE, STENT DEFORMATION OCCURRED. USING THE RIGHT FEMORAL APPROACH, THE PROCEDURE TREATED THE CONCENTRIC TARGET LESION LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO SIGNIFICANT BEND OR TOTAL OCCLUSION LOCATED WITHIN THE LESION. AFTER PRE-DILATION, A 3.0X16MM PROMUS ELEMENT STENT WAS ADVANCED AND DEPLOYED. THEN THE PROXIMAL END OF THE 3.0X16MM PROMUS ELEMENT STENT BECAME DEFORMED WHEN A NON-BSC STENT WAS "RECROSSED" FOR STENTING OF THE DISTAL LAD. THEN POST DILATATION WITH AN UNSPECIFIED BALLOON WAS USED "TO REGAIN THE LUMEN SIZE AND CORRECT THE DISTORTED STENT". NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT ¿	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493911316300	14564649

Patients

Seq	Age	Sex	Outcome	Treatment
1	39 YR		Required Intervention