MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, that during the procedure, the subject stent deployed prematurely within the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
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, the stent was found to be deployed.The stent delivery wire (sdw) was found to be kinked/bent, the stent was found to be deformed.The stent introducer sheath was not returned.Functional inspection was not applicable.Defect confirmed during visual inspection.The reported event was confirmed during the analysis.The device failed to meet specifications when received for complaint investigation, based on the analyzed anomalies noted to the device.The device was analyzed.The stent was found to be deployed and deformed, the sdw was found to be kinked/bent.It is probable, that these damages caused the friction during use and the reported issue.An assignable cause of procedural factors will be assigned to the as reported/ as analyzed; ¿stent deployed prematurely during use¿, and as analyzed codes, ¿ sdw kinked/bent¿, ¿ stent deformed¿.As the issues are 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.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 16834138
• Report Number: 3008881809-2023-00214
• Device Sequence Number: 3276385
• Product Code: OUT
• UDI-Device Identifier: 07613327375282
• UDI-Public: 07613327375282
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 04/28/2023

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: 08/30/2023
• Device Model Number: FDS45040
• Device Catalogue Number: FDS45040
• Device Lot Number: 22422914
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Initial Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2020
• 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: CATHETER (UNKNOWN)
• Patient Sex: Unknown