MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS50040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that resistance was encountered when deploying the subject flow diverter, but the stent was placed in the target site successfully.During re-crossing resistance was encountered when tracking the catheter back over the delivery wire.Upon removal, the resheath pad was found in the distal petal.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the device was returned inside the xt-27 microcatheter.The stent delivery wire (sdw) was found to be deformed and kinked/bent.There was no sdw breakage noted; however, the resheath pad was found dislocated.The stent was not returned.Functional testing was unable to perform as the stent had been implanted successfully inside the patient anatomy.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.As per the additional information the event occurred inside the carotid siphon and there was moderate tortuosity.The device was returned and there was no fracture noted to the sdw, however the re-sheath pad had been dislodged, the sdw was also kinked/bent, confirming that there was friction experienced during the procedure.There was blood noted within the delivery system, which may have caused or contributed to the reported event.It is probable that the anatomical location and tortuosity may have caused the reported friction causing the damage noted to the returned device.An assignable cause of not confirmed was assigned to the reported event sdw broken/fractured during use, as there was no fracture noted to the sdw.An assignable cause of procedural factors were assigned to the reported events stent friction and sdw friction and to the analyzed events sdw - kinked/bent, sdw deformed, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.The product investigation confirmed that the stent delivery wire (sdw) was found intact and not broken/fractured as reported.It is highly unlikely that the kinked/bent and deformation noted on the sdw and the re-sheath pad dislodgment may contributed to and/or cause any patient injury; therefore, this record has been deemed non-reportable with an awareness date of 28-oct-2021.
Event or Problem Description
It was reported that resistance was encountered when deploying the subject flow diverter, but the stent was placed in the target site successfully.During re-crossing resistance was encountered when tracking the catheter back over the delivery wire.Upon removal, the resheath pad was found in the distal petal.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 5.0MM X 40MM - PMAS
• Common Device Name: 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 Key: 12437338
• Report Number: 3008881809-2021-00365
• Device Sequence Number: 3939768
• Product Code: OUT
• UDI-Device Identifier: 07613327375329
• UDI-Public: 07613327375329
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2023
• Device Model Number: FDS50040
• Device Catalogue Number: FDS50040
• Device Lot Number: 22413071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/16/2021
• Supplement Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 09/08/2021
• Supplement Report FDA Received Date: 11/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: EXCELSIOR XT - 27 MICROCATHETER (STRYKER); EXCELSIOR XT - 27 MICROCATHETER (STRYKER)
• Patient Sex: Unknown