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U.S. Department of Health and Human Services

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

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STRYKER NEUROVASCULAR-CALIF UNKNOWN_NEUROVASCULAR_PRODUCT; STENT, INTRACRANIAL NEUROVASCULAR Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109)
Event Date 11/21/2016
Event Type  Injury  
Manufacturer Narrative
This is the 5th 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 were recurrent transient ischemic attack (tia) or stroke that occured in the territory of the stented artery in two of three patients.
 
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.Information from the complaint indicated that, out of the 50 patients who underwent wingspan stenting as part of this clinical study, recurrent transient ischemic attack (tia) or stroke occurred in the territory of the stented artery in two of three patients.The reported patient tia and stroke 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 were recurrent transient ischemic attack (tia) or stroke that occured in the territory of the stented artery in two of three patients.
 
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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 Key6372778
MDR Text Key68823992
Report Number3008881809-2017-00063
Device Sequence Number1
Product Code NJE
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
H050001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/19/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK_NEU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2017
Initial Date FDA Received03/02/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/19/2017
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 Number1
Patient Outcome(s) Other;
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