FDA Adverse Event Injury Summary report: N

PROMUS ELEMENT¿ PLUS

MDR report key: 2872093 · Received December 13, 2012

Report

Report Number: 2134265-2012-07529
Event Type: Injury
Date Received: December 13, 2012
Date of Event: November 14, 2012
Report Date: November 16, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P110010
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GB
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: 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 DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENT IMPLANTATION, STENT DAMAGE OCCURRED. A PROMUS ELEMENT PLUS STENT WAS IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). A 3.0X32MM PROMUS ELEMENT PLUS STENT WAS THEN IMPLANTED IN THE MID-RCA (RIGHT CORONARY ARTERY), AN OVERLAPPING 3.5X24MM PROMUS ELEMENT PLUS STENT WAS REQUIRED TO BE IMPLANTED PROXIMALLY. THE DEVICE WAS ADVANCED AND THE TIP OF THE STENT CAME INTO CONTACT WITH THE PREVIOUSLY DEPLOYED 3.0X32MM STENT WHICH BEGUN TO BUCKLE AND DEFORM. THE NEW STENT WAS ADVANCED AS CLOSE AS POSSIBLE AND WAS IMPLANTED SLIGHTLY OVERLAPPING. THE BOTH STENTS WERE THEN POSTDILATED AND THE OVERLAPPED JUNCTION WAS REPORTED AS DECENT. NO PATIENT COMPLICATION HAS BEEN REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PROMUS ELEMENT¿ PLUS	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493918432300

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention