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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 12MM - IDE; INTRACRANIAL ANEURYSM FLOW DIVERTER
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STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 12MM - IDE; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Catalog Number FDC45012
Device Problem Premature Activation (1484)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  malfunction  
Manufacturer Narrative
The device is not available to the manufacturer.
 
Event Description
It was reported that during a clinical trial procedure with the subject flow diverter for a internal carotid artery-communicating, it detached prematurely.Physician tried to recover the subject flow diverter but was unable to so as the microcatheter was damaged.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
Manufacturer Narrative
H4 manufacturing date added.D4 expiration date added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The product was not returned for analysis therefore the visual and functional inspection was not performed.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.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.Additional information provided by the customer indicated the microcatheter had been damaged distally, making it impossible to reinsert the stent into the catheter.The damage may be secondary to the handling of the stent and the force of the push when the first stent was deployed.There was no unanticipated medical intervention as the device was replaced by another flow diverter.There was no harm to the patient, the 2 device deficiencies did not lead to an ae (based on edc).The patient¿s current condition is no ae.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned for the reported stent deployed prematurely during use.
 
Event Description
It was reported that during a clinical trial procedure with the subject flow diverter for a internal carotid artery-communicating, it detached prematurely.Physician tried to recover the subject flow diverter but was unable to so as the microcatheter was damaged.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
 
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Brand Name
SURPASS EVOLVE 4.5MM X 12MM - IDE
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 Key14053655
MDR Text Key288904892
Report Number3008881809-2022-00161
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
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 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/17/2022
Device Catalogue NumberFDC45012
Device Lot Number21537024
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
EXCELSIOR XT-27 MICROCATHETER (STRYKER).
Patient Age57 YR
Patient SexFemale
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