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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 Stroke/CVA (1770)
Event Date 03/21/2020
Event Type  Injury  
Manufacturer Narrative
Subject device remains implanted.
 
Event Description
It was reported that a patient was successfully treated with a flow diverter (subject device) for an aneurysm located at the posterior inferior cerebellar artery (pica).At approximately 7 month-post-procedure during a follow-up visit, there had been no change in her aneurysm and the medication (plavix) was stopped at that time.Approximately 1 week before the occurrence.The patient suffered a cerebellar stroke.The computed tomography angiography (cta) showed artifact from the subject device with the aneurysm occluded but the pica had stopped filling.No additional information is available at this time.
 
Event Description
It was reported that a patient was successfully treated with a flow diverter (subject device) for an aneurysm located at the posterior inferior cerebellar artery (pica).At approximately 7 month-post-procedure during a follow-up visit, there had been no change in her aneurysm and the medication (plavix) was stopped at that time.Approximately 1 week before the occurrence.The patient suffered a cerebellar stroke.The computed tomography angiography (cta) showed artifact from the subject device with the aneurysm occluded but the pica had stopped filling.No additional information is available at this time.
 
Manufacturer Narrative
Due to the automated mes system (manufacturing execution system),there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device dfu.As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of anticipated procedural complication will be assigned to the reported complaint, as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labelling and/or risk documentation files.
 
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Brand Name
UNKNOWN_NEUROVASCULAR_PRODUCT
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
IE  NA
MDR Report Key9950905
MDR Text Key187302243
Report Number3008881809-2020-00100
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
PMA/PMN Number
P170024
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 06/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK_NEU
Was Device Available for Evaluation? No
Date Manufacturer Received05/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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