MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-CALIF UNKNOWN_NEUROVASCULAR_PRODUCT; STENT, INTRACRANIAL NEUROVASCULAR

Catalog Number UNK_NEU

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

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109); Stenosis (2263)

Event Date 11/21/2016

Event Type  Injury  

Manufacturer Narrative

This is the 6th of 6 reports.Subject device is not available.

Event Description

This article retrospectively evaluate the safety and efficacy of the wingspan device for the treatment of symptomatic intracranial atherosclerotic stenosis (icas).A total of 50 patients (mean age 64.8 ±11.5 years, 39 women and 11 men) fulfilling the inclusion criteria received wingspan stenting in order to treat arterial stenosis between january 2013 and december 2015 were included in the study group.All patients underwent mri to audit any complications during the early follow-up period.Mean stenosis pre-stenting was 76.5 ±13.1% and post-stenting residual stenosis was 19.8 ±13.8%.The overall 30-day rate of procedure-related complications was 6.0% (3/50).Over a median or mean follow-up period which ranged from 1 to 15 months, there was in-stent restenosis defined as superior to 20% of absolute luninal loss was found in one of these three patients having recurrent tia or stroke.

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, patient stroke, patient tia (transient ischemic attack), and patient restenosis are known risks associated with endovascular procedures and are noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complications has been assigned to this event.

Event Description

This article retrospectively evaluate the safety and efficacy of the wingspan device for the treatment of symptomatic intracranial atherosclerotic stenosis (icas).A total of 50 patients (mean age 64.8 ±11.5 years, 39 women and 11 men) fulfilling the inclusion criteria received wingspan stenting in order to treat arterial stenosis between january 2013 and december 2015 were included in the study group.All patients underwent mri to audit any complications during the early follow-up period.Mean stenosis pre-stenting was 76.5 ±13.1% and post-stenting residual stenosis was 19.8 ±13.8%.The overall 30-day rate of procedure-related complications was 6.0% (3/50).Over a median or mean follow-up period which ranged from 1 to 15 months, there was in-stent restenosis defined as superior to 20% of absolute luminal loss was found in one of these three patients having recurrent tia or stroke.

• Brand Name: UNKNOWN_NEUROVASCULAR_PRODUCT
• Type of Device: STENT, INTRACRANIAL NEUROVASCULAR
• Manufacturer (Section D): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer (Section G): STRYKER NEUROVASCULAR-CALIF; 47900 bayside parkway; fremont CA 94538
• Manufacturer Contact: michael reddick ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 6372779
• MDR Text Key: 68828968
• Report Number: 3008881809-2017-00065
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: H050001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NEU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 03/02/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/26/2017
• 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
• Patient Outcome(s): Other