PROMUS ELEMENT ¿

Report

Report Number: 2134265-2012-06768
Event Type: Injury
Date Received: November 14, 2012
Date of Event: October 16, 2012
Report Date: October 16, 2012
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: SIMILAR
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AU
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PATIENT AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A COMBINATION PRODUCT.(B)(4). DEVICE EVALUATED BY MANUFACTURER - DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION OF THIS EVENT IS THAT ANOTHER DEVICE/DRUG/SUBSEQUENT PROCEDURE CAUSED THE COMPLAINT EVENT.(B)(4).

Description of Event or Problem · 1

STENT SHORT. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, STENT DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.0X12MM PROMUS ELEMENT STENT WAS SUCCESSFULLY DEPLOYED AT 16 ATM. A NC QUANTUM APEX BALLOON WAS USED FOR POST-DILATION ATTEMPT. ADVANCING THE BALLOON WAS DIFFICULT SUE TO ANGULATION AT THE OSTIUM OF THE LAD. THE PHYSICAL APPLIED ADDITIONAL FORCE THAT COMPRESSED THE PROXIMAL END OF THE DEPLOYED STENT. THE IMPLANTED STENT COMPRESSED 1-2MM OFF THE PROXIMAL LESION. THE COMPRESSED STENT DID NOT ADEQUATELY COVER THE TARGET LESION; HOWEVER NO ADDITIONAL INTERVENTION WAS ATTEMPTED DUE TO THE LESION PROXIMITY TO THE LEFT MAIN ARTERY. 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	H7493911312300	15366380

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other