MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40017
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Thrombosis/Thrombus (4440)
Date of Event	12/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that the subject flow diverter developed in-stent thrombosis during the procedure, which was treated using another stent and medication.The thrombotic event is related to the study procedure and subject device.The event resolved and patient recovered.No other information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added d4 expiration date - added due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.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.It was reported that the subject flow diverter developed in-stent thrombosis during the procedure, which was treated using another stent (atlas) and medication (aggrastat).The patient outcome was recovered/resolved.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.An assignable cause of anticipated procedural complication will be assigned to the reported patient vessel thrombosis 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 directions for use, product labelling and/or risk documentation files.
Event or Problem Description
It was reported that the subject flow diverter developed in-stent thrombosis during the procedure, which was treated using another stent and medication.The thrombotic event is related to the study procedure and subject device.The event resolved and patient recovered.No other information is available.
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 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.It was reported that the subject flow diverter developed in-stent thrombosis during the procedure, which was treated using another stent (atlas) and medication (aggrastat).Additional information received on 18-may-2021 reported that the patient had a generalized headache post procedure, on the same day of the procedure.The headache was treated with medication (acetaminophen 650mg) and the patient outcome was recovered/resolved.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.An assignable cause of anticipated procedural complication will be assigned to the reported patient vessel thrombosis and patient headache non- serious 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 directions for use, product labelling and/or risk documentation files.
Event or Problem Description
It was reported that the subject flow diverter developed in-stent thrombosis during the procedure, which was treated using another stent and medication.The thrombotic event is related to the study procedure and subject device.The event resolved and patient recovered.No other information is available.Additional information received on 18-may-2021 reported that the patient had a generalized headache post procedure, on the same day of the procedure.Headache was classified as generalized, non serious and was treated with oral medication (acetaminophen 650mg) once daily and it resolved.The headache was possibly related to the subject flow diverter and no diagnostic imaging was performed as a result of the headache.No other information is available.

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11206086
• Report Number: 3008881809-2021-00041
• Device Sequence Number: 14338845
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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,Followup
• Report Date (Section B): 06/14/2021

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: 08/06/2023
• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Device Lot Number: 22387926
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/19/2021; 05/18/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 02/22/2021; 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ATLAS 4X21 STENT (STRYKER); ATLAS 4X21 STENT (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 90