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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device remains implanted inside the patient's vasculature.
Event or Problem Description
It was reported that during the endovascular procedure the subject flow diverting stent had to be loaded and unloaded to get the perfect vessel was apposition.Physician used a j - wire to help massage the subject flow diverting stent so that it can pop off the pad.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the endovascular procedure the subject flow diverting stent had to be loaded and unloaded to get the perfect vessel was apposition.Physician used a j - wire to help massage the subject flow diverting stent so that it can pop off the pad.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D10 product available to stryker ¿ updated.D10 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual/microscopic inspection, only the sdw (stent delivery wire) was returned.The sdw was kinked/bent from the distal end.There was no other anomaly noted with the sdw and the resheath pad was intact.The stent and introducer sheath were not returned.Functional inspection was not applicable as only the sdw was 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.The reported complaint was not 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 indicates there were no anomalies noted to the flow diverter prior to use, the device was prepared as per dfu and continuous flush was maintained.The anatomy was very tortuous.Significant manipulations were required as the device had to be loaded and unloaded to overcome ribboning.The correct size of the device was used and a microcatheter was used to deploy the stent.There was a 10 min surgical delay trying to get the device to pop off and a medical intervention was performed to release the stent from the re-sheath marker by using a j-wire to help massage device and pop off pad.The physician was able to deliver the flow diverter device to the target lesion and the stent was deployed properly in the anatomy.In the physician¿s opinion, the cause of the reported issue is unknown.Analysis of the returned device found only the sdw was returned and it was found to be kinked/bent from the distal end.It is probable the sdw became damaged during manipulation of the device.As the stent was not returned having been deployed in the patient¿s anatomy, the as reported ¿stent failed/unable to deploy¿ could not be confirmed.An assignable cause of procedural factors will be assigned to the as analyzed ¿sdw kinked/bent¿ 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.An assignable cause of anticipated procedural complication will be assigned to the as reported ¿patient medical or surgical intervention required¿ as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.

• 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: 17371245
• Report Number: 3008881809-2023-00366
• Device Sequence Number: 7036683
• Product Code: OUT
• UDI-Device Identifier: 07613327375329
• UDI-Public: 07613327375329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/22/2024
• Device Model Number: FDS50040
• Device Catalogue Number: FDS50040
• Device Lot Number: 22748452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/21/2023
• 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); UNKNOWN GUIDEWIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown