CAROTID WALLSTENT MONORAIL

Report

Report Number: 2134265-2010-04686
Event Type: Injury
Date Received: October 19, 2010
Date of Event: August 6, 2010
Report Date: September 22, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIM
PMA / PMN Number: P050019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NE, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). DEVICE EVALUATED BY MANUFACTURER. AS THE DEVICE HAS NOT BEEN RETURNED, THE COMPLAINT INVESTIGATION SITE (CIS) COULD NOT PERFORM A TECHNICAL ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THIS BATCH FOUND THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

Description of Event or Problem · 1

(B)(4). IT WAS REPORTED THAT DURING A CAROTID ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED HYPOTENSION AND BRADYCARDIA. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE LEFT INTERNAL CAROTID ARTERY WITH 90% STENOSIS, A LENGTH OF 15 MM, AND A REFERENCE VESSEL DIAMETER OF 6 MM. THE PHYSICIAN TREATED THE LESION WITH A FILTERWIRE EZ AND PLACEMENT OF A CAROTID WALLSTENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 10%. DURING THE PROCEDURE, THE PATIENT EXPERIENCED BRADYCARDIA AND HYPOTENSION. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS THE SAME DAY. THE PATIENT WAS DISCHARGED THE NEXT DAY. IN THE OPINION OF THE PHYSICIAN THE RELATIONSHIP OF THE EVENT TO THE CAROTID WALLSTENT IS PROBABLE AND THE RELATIONSHIP TO THE FILTERWIRE IS UNRELATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAROTID WALLSTENT MONORAIL	STENT, CAROTID	NIM	BOSTON SCIENTIFIC - GALWAY	M001719040	13446104

Patients

Seq	Age	Sex	Outcome	Treatment
1	78 YR		Required Intervention	FILTERWIRE EZ