MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 25MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45025
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Intracranial Hemorrhage (1891); Ruptured Aneurysm (4436)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted in the patient.
Event or Problem Description
It was reported that after completion of treatment of a giant ophthalmic aneurysm on (b)(6) 2022 using stent (subject device), approximately 12 hours post procedure the patient was brought back to angio suite with stroke symptoms.There was no clot to be retrieved.It was confirmed to be hem aneurysm rupture of same treated aneurysm.There was some bleeding and subarachnoid hemorrhage.Patient was and continues to be on aspirin and plavix as dual anti platelet therapy (dapt) before and after the surgery.Stent (subject device) was reported to be performed as intended.An additional diagnostic was done on 18 october.Patient was kept in the hospital for an additional week and had another stent placed on 24 october at same location of subject stent.Indication of using another stent is unknown.Patient¿s current condition is improving with some slight deficits.No other information is available.
Additional Manufacturer Narrative
D4: expiration date: added.H4: manufacturing date: added.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.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.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.Additional information provided by the customer indicated the physician completed treatment of a giant ophthalmic aneurysm using surpass evolve and axium coils.Approximately 12 hours post procedure the patient was brought back to angio suite with stroke symptoms.There was no clot to be retrieved.Patient was kept in the hospital for an additional week and had another flow diverter placed this monday.Slight deficit noted.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.As a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to the reported ¿patient stroke, patient aneurysm rupture and patient intracranial hemorrhage¿.
Event or Problem Description
It was reported that after completion of treatment of a giant ophthalmic aneurysm on (b)(6) 2022 using stent (subject device), approximately 12 hours post procedure the patient was brought back to angio suite with stroke symptoms.There was no clot to be retrieved.It was confirmed to be hem aneurysm rupture of same treated aneurysm.There was some bleeding and subarachnoid hemorrhage.Patient was and continues to be on aspirin and plavix as dual anti platelet therapy (dapt) before and after the surgery.Stent (subject device) was reported to be performed as intended.An additional diagnostic was done on 18 october.Patient was kept in the hospital for an additional week and had another stent placed on (b)(6) at same location of subject stent.Indication of using another stent is unknown.Patient¿s current condition is improving with some slight deficits.No other information is available.

• Brand Name: SURPASS EVOLVE 4.5MM X 25MM - 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: 15756666
• Report Number: 3008881809-2022-00558
• Device Sequence Number: 15103477
• Product Code: OUT
• UDI-Device Identifier: 07613327375268
• UDI-Public: 07613327375268
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/08/2022

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 Expiration Date: 12/14/2023
• Device Model Number: FDS45025
• Device Catalogue Number: FDS45025
• Device Lot Number: 22643754
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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: AXIUM COIL(NON-STRYKER).; BALLAST .081IN SHEATH(NON-STRYKER).; ECHELON 10 MICROCATHETER(NON-STRYKER).; PHENOM 27 MICROCATHETER(NON-STRYKER).; TARGET COIL(STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown