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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 25MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 25MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDS32525
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Memory Loss/Impairment (1958); Loss of Vision (2139); Dysphasia (2195); Shaking/Tremors (2515); Taste Disorder (4422); Epistaxis (4458); Partial Hearing Loss (4472); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/02/2022
Event Type  Injury  
Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release. The subject device is not available; therefore, functional testing as well as visual testing cannot be performed. 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. It was reported that the patient 'believes that she has an allergy to the implanted device'. Due to a lack of information on the event, and while there are a number of potential causes for the reported issue, analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to this complaint. The dfu states the following warning: persons allergic to nickel, cobalt chromium or platinum tungsten metal may suffer an allergic response to this system. The device is not available to the manufacturer, as device is implanted in patient.
 
Event Description
It was reported that neuro endovascular flow diverter implantation procedure was performed on female patient. Patient believes that she has an allergy to the implanted device. Patient is consulting the physician for post-operative follow up regarding allergies and side effects. Flow diverter implantation was performed by a different physician at a different facility, details related to the procedure were unknown. Physician ran lab work which indicated 2. 0 chromium levels in urine and also high levels of arsenic was noted. Patient was having them re-tested by a rheumatologist. No other information is available.
 
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Brand NameSURPASS EVOLVE 3.25MM X 25MM - PMAS
Type of DeviceINTRACRANIAL 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 Key13944695
MDR Text Key288693093
Report Number3008881809-2022-00144
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
Type of Report Initial,Followup
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberFDS32525
Device Lot Number22240714
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2020
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: 03/29/2022 Patient Sequence Number: 1
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