FDA Adverse Event Injury Summary report: N

CAROTID WALLSTENT MONORAIL

MDR report key: 1822422 · Received September 1, 2010

Report

Report Number: 2134265-2010-03771
Event Type: Injury
Date Received: September 1, 2010
Date of Event: September 17, 2009
Report Date: August 6, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: NIM
PMA / PMN Number: P050019
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). 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

(B)(4). IT WAS REPORTED THAT FOLLOWING A CAROTID ARTERY STENTING TREATMENT PROCEDURE, THE PATIENT DEVELOPED HYPOTENSION. THE INDEX PROCEDURE TREATED AN 82% STENOSED, 8X40MM LESION IN THE RIGHT INTERNAL CAROTID ARTERY. TREATMENT CONSISTED OF ATTEMPTED PLACEMENT OF A FILTERWIRE EZ; HOWEVER, THE DEVICE WAS UNABLE TO BE PLACED DUE TO VESSEL TORTUOSITY. AN 8X36MM CAROTID WALLSTENT WAS SUCCESSFULLY IMPLANTED WITH POST DILATION RESULTING IN 3% RESIDUAL STENOSIS. THE PATIENT EXPERIENCED HYPOTENSION IN THE RECOVERY ROOM AND WAS TREATED WITH A SALINE FLUID BOLUS TO SUPPORT BLOOD PRESSURE. THE PATIENT WAS ASYMPTOMATIC AT THE TIME OF THE EVENT. THE PATIENT WAS DISCHARGED ONE DAY POST PROCEDURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CAROTID WALLSTENT MONORAIL	STENT, CAROTID	NIM	BOSTON SCIENTIFIC - GALWAY	M001719030	0012510364

Patients

Seq	Age	Sex	Outcome	Treatment
1	77 YR		Required Intervention