MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45012
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during flow diverter implantation procedure in a patient with posterior communicating artery aneurysm, the proximal end of the subject flow diverter stent did not open completely and it narrowed like a cone.The physician tried to angioplasty the proximal end of the stent open with a balloon but that didn¿t work.Hence, the physician put another stent on top of the subject device to make the proximal end appose the vessel wall.The procedure was completed successfully.No other clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device remains implanted in the patient.
Event or Problem Description
It was reported that during flow diverter implantation procedure in a patient with posterior communicating artery aneurysm, the proximal end of the subject flow diverter stent did not open completely and it narrowed like a cone.The physician tried to angioplasty the proximal end of the stent open with a balloon but that didn¿t work.Hence, the physician put another stent on top of the subject device to make the proximal end appose the vessel wall.The procedure was completed successfully.No other 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.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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 reported event of stent failed/unable to open¿.H3 other text : the device remains implanted in the patient.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 14250862
• Report Number: 3008881809-2022-00201
• Device Sequence Number: 5043629
• Product Code: OUT
• UDI-Device Identifier: 07613327386592
• UDI-Public: 07613327386592
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2023
• Device Model Number: FDS45012
• Device Catalogue Number: FDS45012
• Device Lot Number: 22510831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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: NEUROFORM ATLAS (STRYKER); TRANSFORM (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Female
• Patient Race: White