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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number UNK_NEU
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 10/16/2018
Event Type  Injury  
Manufacturer Narrative

The device history record review could not be performed since the lot number was not known. The subject device was not returned as it was implanted; therefore, functional testing as well as physical analysis could not be performed. The reported event is anticipated in nature as per the product directions for use. As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of anticipated procedural complication will be assigned to this complaint. Subject device is not available.

 
Event Description

It was published in the journal of interventional neurology, an article stating that two iatrogenic cervical ica dissections occured in a study of the subject flow diverter, one of which was treated with further flow diversion from unknown manufacturer. The other ica dissection was missed at the time of the procedure and resulted in the occlusion of the vessel. No further information is available.

 
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Brand NameUNKNOWN_NEUROVASCULAR_PRODUCT
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key9470539
MDR Text Key170791871
Report Number3008881809-2019-00390
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/13/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK_NEU
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
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 TREATMENT DATA
Date Received: 12/13/2019 Patient Sequence Number: 1
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