MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40020
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device remains implanted inside the patient.
Event or Problem Description
It was reported that the subject flow diverter implantation procedure was performed for aneurysm of right ica (internal carotid artery) ophthalmic segment in a patient with tortuous anatomy.Flow diverter was confirmed to be fully deployed under fluoroscopy during the procedure.The subject stent distal migration was reported.One week after procedure subject stent occluded proximally due to clot formation at ica and patient reported to have stroke like symptoms.Physician used a non-stryker catheter for clot aspiration as a medical intervention.Patient is reported to be stable.No further 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 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.Based on the information provided in the complaint, indicated there was no damage noted to the packaging prior to preparation of the device, there were no anomalies noted to the device after removal from the packaging or prior to preparation, the device was confirmed to be in good condition prior to use, the device was prepared as per the dfu, continuous flush was maintained throughout the procedure, the procedure was completed successfully with this device.No excessive force was applied at any point while advancing the flow diverter within the microcatheter.The flow diverter was confirmed to be fully deployed under fluoroscopy during the procedure.A microcatheter was used with the stent.The condition being treated was aneurysm or using from right ica, ophthalmic.The anatomical location where the issue occurred was the right ica.The patient¿s anatomy was tortuous and the tight tortuosity could have contributed to the reported event.A medical intervention was required - aspirated clot out and opened device with aspiration catheter.The initial procedure was femoral.The initial case was tricia's.The flow diverter appeared to be fully opposed to the vessel wall when it was deployed.The stent migrated distally and the action taken - migrated and closed proximally so aspiration catheter was advanced to gain access and aspirate out clot.The patient suffered a stroke 1 week after procedure.The stroke was identified when ica shut down patient came to er with stroke like symptoms.The implant was not deployed in the vessel during vasospasm.The vessel size during the procedure was 3.8 and the vessel size after the procedure was 3.8.The adverse event did not result in inpatient hospitalization or prolongation of existing hospitalization.The patient needs repeat surgery as aneurysm is no longer secured.The antiplatelet (e.G., aspirin and clopidogrel etc.) was administered as prophylaxis post procedure as per recommendation.The patient responded to dapt.That was not an issue.The patient¿s current condition is stable.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 to the reported issue ¿stent dislodged/migrated¿.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient stroke¿ and ¿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 with the directions for use, product labeling and/or risk documentation files.
Event or Problem Description
It was reported that the subject flow diverter implantation procedure was performed for aneurysm of right ica (internal carotid artery) ophthalmic segment in a patient with tortuous anatomy.Flow diverter was confirmed to be fully deployed under fluoroscopy during the procedure.The subject stent distal migration was reported.One week after procedure subject stent occluded proximally due to clot formation at ica and patient reported to have stroke like symptoms.Physician used a non-stryker catheter for clot aspiration as a medical intervention.Patient is reported to be stable.No further information is available.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - 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: 15014384
• Report Number: 3008881809-2022-00343
• Device Sequence Number: 12467356
• Product Code: OUT
• UDI-Device Identifier: 07613327375206
• UDI-Public: 07613327375206
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 10/07/2022

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: 10/25/2024
• Device Model Number: FDS40020
• Device Catalogue Number: FDS40020
• Device Lot Number: 23265859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 09/12/2022
• Initial Report FDA Received Date: 07/14/2022
• Supplement Report FDA Received Date: 10/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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 INTERMEDIATE CATHETER (STRYKER).; EXCELSIOR XT- 27 (STRYKER).; NEURON MAX LONG SHEATH ( PENUMBRA).; SOFIA ASPIRATION CATHETER (MICROVENTION).
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown