MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40015
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the posterior communicating artery aneurysm treatment, the physician encountered difficulty in positioning the subject flow diverter inside the patient anatomy.While deploying the subject flow diverter inside the patient anatomy, it was partially deployed and moved away from the lesion where it was deployed.The physician re-sheathed the subject flow diverter and removed it from the patient's anatomy.The patient's vessel tortuosity was reported to be tortuous.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.No visual or functional inspection was performed due to 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 device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was severely tortuous, the stent delivery system was repositioned twice, no resistance was encountered during navigation of the flow diverter to the target lesion or during deployment, the stent delivery microcatheter was retracted in a continuous movement while maintaining the position of the stent delivery wire, and the size of the stent/flow diverter was appropriate for the treatment site.Other devices used in the procedure in conjunction with the subject flow diverter included an excelsior xt-27 microcatheter, phenom plus intermediate catheter , and infinity long sheath.In the case of this complaint, it is probable that tortuous anatomy contributed to the reported issues.An assignable cause of procedural factors will be assigned to this complaint since the issues are associated with a product that meets stryker design and manufacturing specifications and was used in accordance 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 the posterior communicating artery aneurysm treatment, the physician encountered difficulty in positioning the subject flow diverter inside the patient anatomy.While deploying the subject flow diverter inside the patient anatomy, it was partially deployed and moved away from the lesion where it was deployed.The physician re-sheathed the subject flow diverter and removed it from the patient's anatomy.The patient's vessel tortuosity was reported to be tortuous.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: SURPASS EVOLVE 4.0MM X 15MM - 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: 13358283
• Report Number: 3008881809-2022-00038
• Device Sequence Number: 1663054
• Product Code: OUT
• UDI-Device Identifier: 07613327375190
• UDI-Public: 07613327375190
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 04/22/2022

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: 07/12/2023
• Device Model Number: FDS40015
• Device Catalogue Number: FDS40015
• Device Lot Number: 22336558
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 01/26/2022
• Supplement Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2020
• 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: AXS INFINITY LONG SHEATH (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); PHENOM PLUS INTERMEDIATE CATHETER (MEDTRONIC)
• Patient Age: 68 YR
• Patient Sex: Male