MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS32512
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after deployment of the stent (subject device), the physician attempted to track the catheter back over the delivery wire which was through the stent (subject device).After re-crossing the stent (subject device), the catheter seemed to get stuck at the resheath pad.The physician explained he was feeling the excessive force when trying to track the catheter further over the delivery wire.He pulled the catheter back and retracted it over the resheath pad.There was a force and a release of force as the catheter went past the resheath marker.At this point, he pulled out the delivery wire.When we visually inspected the delivery wire, the resheath pad had moved and was located at the distal tip of the stent delivery wire (subject device), just proximal to the distal marker and petals.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to manufacturer.
Event or Problem Description
It was reported that after deployment of the stent (subject device), the physician attempted to track the catheter back over the delivery wire which was through the stent (subject device).After re-crossing the stent (subject device), the catheter seemed to get stuck at the resheath pad.The physician explained he was feeling the excessive force when trying to track the catheter further over the delivery wire.He pulled the catheter back and retracted it over the resheath pad.There was a force and a release of force as the catheter went past the resheath marker.At this point, he pulled out the delivery wire.When we visually inspected the delivery wire, the resheath pad had moved and was located at the distal tip of the stent delivery wire (subject device), just proximal to the distal marker and petals.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system, there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the sdw (stent delivery wire) was found to be kinked/bent, the sdw resheath pad was found to be dislocated, there was no sdw (stent delivery wire) breakage noted, and the stent was not returned.(the stent was used in the procedure).A functional test was not performed, the reported event was not 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 sdw (stent delivery wire) fracture was not confirmed.The device interaction with another device could not be confirmed during analysis as the event is procedure/patient related.The device failed to meet specification when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The sdw was found to be kinked/bent.There was no sdw breakage/fracture noted during the analysis.An assignable cause of not confirmed will be assigned to the reported ¿sdw broken/fractured during use¿, as the defect was not confirmed.An assignable cause of undeterminable will be assigned to the reported ¿device interaction with another device¿, as there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause.An assignable cause of handling damage will be assigned to analyzed ¿sdw kinked/bent¿ as this complaint appears to be associated with handling of the product or portion of the product during the procedure.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: SURPASS EVOLVE 3.25MM X 12MM - 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: 14283291
• Report Number: 3008881809-2022-00204
• Device Sequence Number: 15139306
• Product Code: OUT
• UDI-Device Identifier: 07613327385625
• UDI-Public: 07613327385625
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• 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): 07/21/2022

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: 02/16/2024
• Device Model Number: FDS32512
• Device Catalogue Number: FDS32512
• Device Lot Number: 22748458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2021
• 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: XT - 27 CATHETER (STRYKER)
• Patient Sex: Unknown