MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MINN UNKNOWN_NEUROVASCULAR_PRODUCT; CATHETER, BALLOON TYPE

Catalog Number UNK_NEU

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Death (1802); Transient Ischemic Attack (2109)

Event Date 09/01/2013

Event Type  Death  

Manufacturer Narrative

The exact date of the adverse event is unknown.All patients were treated between (b)(6) 2013 and (b)(6) 2015.This report is 2 of 2 covering balloon treated patients that experienced strokes, transient ischemic attacks and death.The subject device is not available.

Event Description

The stroke journal documented the results of a thirty-day outcome of a multicenter registry study of stenting for symptomatic intracranial artery stenosis.The article informed that 141 patients were treated with the balloon (subject device) pre-dilation plus self-expanding stenting.Of the patients treated, 6 patients had a 30 days primary end points of stroke, transient ischemic attack, and death.In addition, 6 patients had secondary end points of unsuccessful revascularization.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.No additional information is available.

Manufacturer Narrative

A review of the device history record could not be performed because the lot number was not reported.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.However, transient ischemic attack(tia), stroke and death are known risks associated with endovascular procedures and are listed as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications was assigned to this event.

Event Description

The stroke journal documented the results of a thirty-day outcome of a multicenter registry study of stenting for symptomatic intracranial artery stenosis.The article informed that 141 patients were treated with the balloon (subject device) pre-dilation plus self-expanding stenting.Of the patients treated, 6 patients had a 30 days primary end points of stroke, transient ischemic attack, and death.In addition, 6 patients had secondary end points of unsuccessful revascularization.It was not possible to ascertain specific device or patient information from the article, or to match the events reported with previously reported complaints.No additional information is available.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: CATHETER, BALLOON TYPE
• Manufacturer (Section D): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - MINN; one scimed place; maple grove MN 55311
• Manufacturer Contact: sanda dracic ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 5564667
• MDR Text Key: 42235942
• Report Number: 3008853977-2016-00128
• Device Sequence Number: 0
• Product Code: PAV
• Reporter Country Code: CN
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2016
• Initial Date FDA Received: 04/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: WINGSPAN (STRYKER NEUROVASCULAR)
• Patient Outcome(s): Death; Other
• Patient Age: 57 YR