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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 Migration (4003)
Patient Problems Neurological Deficit/Dysfunction (1982); Visual Disturbances (2140); Stenosis (2263)
Event Date 11/28/2019
Event Type  Injury  
Manufacturer Narrative

The subject device remains implanted in the patient.

 
Event Description

It was reported that six months after the procedure in the opthalmic artery, imaging showed 80% neointimal hyperplasia. The neointimal hyperplasia is worse proximally but involves the entire device. The patient had associated visual disturbances and neurological symptoms and has been put on medical management. The physician says the subject flow diverter has changed position since deployment and the patient may require a subsequent recanalization procedure. No difficulties were noted during the initial procedure. 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
NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key10218940
MDR Text Key197157368
Report Number3008881809-2020-00190
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberP170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/02/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/01/2020
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 Received08/13/2020
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: 07/01/2020 Patient Sequence Number: 1
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