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

Model Number	FDS32512
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Stroke/CVA (1770); Speech Disorder (4415); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the procedure, the patient experienced a left temporal stroke with speech issues.The physician changed the p2y12 inhibitor from brilenta to efficient.No other information was provided.
Additional Manufacturer Narrative
The subject device remained inside patient.
Event or Problem Description
It was reported that after the procedure, the patient experienced a left temporal stroke with speech issues.The physician changed the p2y12 inhibitor from brilenta to efficient.No other information was provided.Update information: additional information received on 19-jul-2022 confirmed that the reported event as the patient was non responder to the plavix and the physician does not think the stroke is related to the placement of the subject stent device.In the physician¿s opinion, there was no alleged malfunction of the subject stent device during the procedure and the subject stent device functioned properly.Therefore, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with a new awareness date of 19-jul-2022.
Additional Manufacturer Narrative
B1 product problem: correction: ¿no adverse event ¿ b2 outcomes attributed to ae: correction: ¿no outcomes attributed to ae¿ h1 type of reportable event: correction: ¿no serious injury¿ device code grid: correction: ¿no apparent adverse event¿ f10 / h6 health effect - clinical code: correction: ¿no clinical signs, symptoms or conditions¿ f10 / h6 health effect - impact code: correction: ¿no health consequences or impact b5 executive summary: updated.Additional information received on 19-jul-2022 confirmed that the reported event as the patient was non responder to the plavix and the physician does not think the stroke is related to the placement of the subject stent device.In the physician¿s opinion, there was no alleged malfunction of the subject stent device during the procedure and the subject stent device functioned properly.Therefore, this event does not meet reporting criteria anymore and the reportability will be changed from reportable to non-reportable with a new awareness date of 19-jul-2022 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: 15059284
• Report Number: 3008881809-2022-00360
• Device Sequence Number: 4784383
• Product Code: OUT
• UDI-Device Identifier: 07613327385625
• UDI-Public: 07613327385625
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 07/26/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: FDS32512
• Device Catalogue Number: FDS32512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2022
• Supplement Date Received by Manufacturer: 07/19/2022
• Initial Report FDA Received Date: 07/19/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 44 YR
• Patient Sex: Female