MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 30MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS50030
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
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 stent was returned together with the microcatheter.The microcatheter was found to be intact.The stent was found to be deployed.The stent was found to be deformed with the braid edges frayed.The tip of the stent introducer sheath was found to be damaged.The sdw was found to be intact.During functional inspection, stent difficult/unable to advance or pull back through catheter functional test - unable to perform as the stent was found to be deployed and the tip of the introducer sheath was found to be damaged.Stent deployed prematurely during use functional test ¿ n/a.Confirmed during visual inspection.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 was confirmed based on analysis.The device failed to meet specification when received for complaint investigation based on the analyzed anomaly noted to the device.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and preparation/set-up was performed as per the directions for use.Continuous flush was maintained for the duration of the procedure.The introducer sheath was properly inserted all the way into the microcatheter prior to transfer.While the introducer sheath was seated at the hub, the rhv was opened enough to allow passage of the device through without damage.Microcatheter was used with the stent.A new microcatheter was used to complete the procedure.The stent was stuck far enough into proximal shaft that evolve not seen until pulled back on wire and saw it approaching hub.It is unknown if the fds deployed prematurely.The exact location that the flow diverter was stuck cannot be confirmed but it was in the shaft.It occurred during advancement so the physician pulled back on the delivery wire because it got stuck.There was no surgical delay.The condition being treated was brain aneurysm and the anatomical location of the treatment site was ica.Product analysis found the stent had been deployed and it was deformed with the braid edges frayed.The tip of the stent introducer sheath was also found to be damaged which indicates the device experienced a significant force during the procedure.An assignable cause of procedural factors will be assigned to the reported stent difficult/unable to advance or pull back through catheter and stent deployed prematurely during use and as analysed stent deployed prematurely during use, stent deformed, and stent introducer sheath distal tip damaged 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.
Event or Problem Description
It was reported that during endovascular aneurysmal flow diverter placement procedure in the internal carotid artery(ica) , while advancement of the flow diverter stent, physician felt resistance inside the microcatheter.Exact location where flow diverter was stuck was unknown.The subject flow diverting stent was deployed prematurely inside the microcatheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 5.0MM X 30MM - 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: 14598129
• Report Number: 3008881809-2022-00267
• Device Sequence Number: 5426875
• Product Code: OUT
• UDI-Device Identifier: 07613327375312
• UDI-Public: 07613327375312
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: 02/22/2024
• Device Model Number: FDS50030
• Device Catalogue Number: FDS50030
• Device Lot Number: 22413072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/07/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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)
• Patient Sex: Unknown