FDA Adverse Event Injury Summary report: N

PROMUS PREMIER?

MDR report key: 3894060 · Received June 25, 2014

Report

Report Number: 2134265-2014-03541
Event Type: Injury
Date Received: June 25, 2014
Date of Event: May 8, 2014
Report Date: May 27, 2014
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIQ
PMA / PMN Number: P110010
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: (B)(6). DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 EMBOLIZATION AND MIGRATION OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TO SEVERELY TORTUOUS AND MODERATELY CALCIFIED MID RIGHT CORONARY ARTERY (RCA). A 2.25X16MM PROMUS PREMIER¿ STENT DELIVERY SYSTEM WAS ADVANCED; HOWEVER, THE CATHETER WAS UNABLE TO CROSS THE LESION AND THE STENT DISLODGED. THE STENT WAS INITIALLY SEEN VIA X-RAY IN THE PROXIMAL RIGHT CORONARY ARTERY; HOWEVER, SHORTLY THEREAFTER, THE STENT WAS NO LONGER VISIBLE BY X-RAY. THE PROCEDURE ENDED WITH PTCA PERFORMED WITH A BALLOON. A FULL BODY CT SCAN REVEALED THE STENT WAS FOUND IN THE LEFT PROFUNDA IN A "MUSCULAR BRANCH." NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
371932	PROMUS PREMIER?	STENT, CORONARY, DRUG-ELUTING	NIQ	BOSTON SCIENTIFIC - GALWAY	H7493952816220	0016390689

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other