PROMUS PREMIER?

Report

Report Number: 2134265-2014-03846
Event Type: Injury
Date Received: July 3, 2014
Date of Event: June 9, 2014
Report Date: June 9, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P110010
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS A 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 THAT STENT DAMAGE POST DEPLOYMENT AFTER SECONDARY DEVICE INTERACTION OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS SAPHENOUS VEIN GRAFT (SVG) TO AN OBTUSE MARGINAL ARTERY. DURING PROCEDURE THE PHYSICIAN USED A NON-BSC WIRE BUT HE ENDED UP PLACING A 3.50X38MM PROMUS PREMIER STENT WIRE TO TREAT THE LESION. AS HE WAS RETRIEVING THE NON-BSC WIRE THE END PART OF IT DEFORMED THE PROXIMAL END OF THE PROMUS STENT. THE NON-BSC DEVICE GOT ENTANGLED IN THE STENT BUT WAS ABLE TO REMOVE THE NON-BSC WIRE OUT OF THE STENT, THE NON BSC WIRE WAS PUT DOWN TO BRING A BALLOON BUT IT THEN DEFORMED THE STENT DOWN TO APPROXIMATELY 16MM-20MM IN LENGTH. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
390117	PROMUS PREMIER?	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493952838350	16826184

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention