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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDS40017
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Dysphasia (2195); Speech Disorder (4415); Ischemia Stroke (4418)
Event Date 09/16/2021
Event Type  Injury  
Manufacturer Narrative
Device is implanted in patient.
 
Event Description
It was reported that the subject flow diverter was used in a clinical trial to treat a left internal carotid artery (lica) aneurysm successfully.Post procedure, the patient developed aphasia and mild dysarthria and an mri scan was done which showed small punctuate insular stroke due to small emboli.Mra showed patent lica stent and open distal vessels.Patient had a prolonged hospitalization due to event and was treated with medication.Event was reported to have resolved the next day and the patient was discharged.No other information is available.
 
Event Description
It was reported that the subject flow diverter was used in a clinical trial to treat a left internal carotid artery (lica) aneurysm successfully.Post procedure, the patient developed aphasia and mild dysarthria and an mri scan was done which showed small punctuate insular stroke due to small emboli.Mra showed patent lica stent and open distal vessels.Patient had a prolonged hospitalization due to event and was treated with medication.Event was reported to have resolved the next day and the patient was discharged.No other information is available.
 
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.The reported event is covered in the device directions for use (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.Additional information provided by the customer indicated that the subject flow diverter was implanted successfully with no device deficiencies noted.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.
 
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Brand Name
SURPASS EVOLVE 4.0MM X 17MM - PMAS
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI  NA
Manufacturer (Section G)
STRYKER NEUROVASCULAR CORK
ida industrial estate
model farm road
cork NA
EI   NA
Manufacturer Contact
tara lopez
47900 bayside parkway
fremont, CA 94538
5104132500
MDR Report Key12637231
MDR Text Key276582564
Report Number3008881809-2021-00438
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170024/S003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/15/2022
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 Expiration Date09/14/2023
Device Catalogue NumberFDS40017
Device Lot Number22452424
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/22/2021
Initial Date FDA Received10/14/2021
Supplement Dates Manufacturer Received12/28/2021
Supplement Dates FDA Received01/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2020
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) Hospitalization; Required Intervention; Other;
Patient Age79 YR
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceWhite
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