MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40012
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the internal carotid artery aneurysm procedure, the subject stent came off its re-sheath pad and deployed prematurely inside the microcatheter.Physician re-captured the subject stent using the distal access catheter and removed it from patient' anatomy.The physician replaced the microcatheter and stent with new devices to complete the procedure.There were no clinical consequences to the patient.
Event or Problem Description
It was reported that during the internal carotid artery aneurysm procedure, the subject stent came off its re-sheath pad and deployed prematurely inside the microcatheter.Physician re-captured the subject stent using the distal access catheter and removed it from patient' anatomy.The physician replaced the microcatheter and stent with new devices to complete the procedure.There were no 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.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned for the as reported ¿stent deployed prematurely during use¿.

• Brand Name: SURPASS EVOLVE 4.0MM 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: 14600178
• Report Number: 3008881809-2022-00270
• Device Sequence Number: 6146657
• Product Code: OUT
• UDI-Device Identifier: 07613327386516
• UDI-Public: 07613327386516
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 08/24/2022

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: 11/09/2023
• Device Model Number: FDS40012
• Device Catalogue Number: FDS40012
• Device Lot Number: 22576180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2022
• Supplement Date Received by Manufacturer: 07/31/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 08/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2020
• 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 CATALYST 5 DISTAL ACCESS CATHETER (STRYKER); AXS INFINITY LONG SHEATH (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); PHENOM 27 CATHETER (MEDTRONIC)
• Patient Age: 52 YR
• Patient Sex: Female