FDA Adverse Event Injury Summary report: N

CAROTID WALLSTENT MONORAIL

MDR report key: 1801350 · Received August 16, 2010

Report

Report Number: 2134265-2010-03638
Event Type: Injury
Date Received: August 16, 2010
Date of Event: July 15, 2010
Report Date: July 22, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIM
PMA / PMN Number: P050019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6).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

(B)(4). SAME CASE AS MFR REPORT #: 2134265-2010-03639. IT WAS REPORTED THAT THE SAME DAY OF A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS IN THE RIGHT HAND. THE INDEX PROCEDURE TREATED THE 80% STENOSED, 6X15MM TARGET LESION LOCATED IN THE LEFT OSTIUM INTERNAL CAROTID ARTERY. TREATMENT UTILIZED A BSC FILTERWIRE EZ AND PLACED A 10X24MM CAROTID WALLSTENT. FOLLOWING POST DILATION WITH AN UNSPECIFIED DEVICE THE RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY AS THE PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS OF THE RIGHT THUMB AND TWO FINGERS. NO ACTION WAS TAKEN TO TREAT THE EVENT AND THE EVENT RESOLVED THE SAME DAY WITH NO RESIDUAL EFFECT. THE PATIENT WAS DISCHARGED THE NEXT DAY. PER THE PHYSICIAN, THE EVENT WAS LISTED AS "POSSIBLY RELATED" TO THE STUDY DEVICES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAROTID WALLSTENT MONORAIL	STENT, CAROTID	NIM	BOSTON SCIENTIFIC - GALWAY	M001719040	13129177

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Other	FILTERWIREEZ