MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS32515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Stenosis (2263)
Date of Event	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device remained inside patient.
Event or Problem Description
It was reported that the subject flow diverter device was successfully implanted from proximal right mca (middle cerebral artery) to supraclinoid segment of right ica (internal carotid artery).19 days post flow diverter stent placement procedure, the patient experienced stroke like symptoms and was admitted to hospital for evaluation.Computed tomography angiography (cta) and magnetic resonance angiogram (mra) were performed showing narrowing of implanted device.Patient then had followed up angiogram showing severe stenosis of vessel.Oral steroids and additional anticoagulation were administered to the patient.Per physician¿s opinion, stroke, severe stenosis of vessel and deformation of implanted device were caused by potential nickel allergy/allergic reaction to something in the subject flow diverter device.Patient current condition is stable, but carotid has completely shut down (aneurysm is gone, but so is the parent vessel).
Additional Manufacturer Narrative
The device history record (dhr) review cannot be performed because the lot number was not provided.However, there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not returned; therefore, physical as well as a functional evaluation could not 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.Additional information provided by the customer indicated the surpass evolve flow diverter was confirmed to be in good condition after unpacking and during preparation and the surpass evolve flow diverter was prepared as per dfu.The patient¿s current condition is stable, but carotid has completely shut down.In the physician¿s opinion, the cause of the stroke, they believe this is related to a potential nickel allergy.To be determined by future testing.The stroke is related to the subject surpass evolve flow diverter device.In the physician¿s opinion the cause of the severe stenosis of vessel and deformation of implanted device was allergic reaction to something in the device.The percentage stenosis and calcification at the lesion was 99% at time of report.Now completely occluded.The degree of narrowing of the device was 100%.The procedure name and anatomical location of intended treatment was embolization of right pcomm aneurysm.Device implanted from proximal right mca to supraclinoid segment of right ica.The size of the surpass evolve flow diverter was appropriate for the treatment site.There was no difficulty implanting the subject stent.The surpass evolve flow diverter was confirmed to be fully deployed /opened under fluoroscopy during procedure.The patient¿s anatomy was moderately tortuous.The changes observed in size or shape of aneurysm during follow up is less than one month.Aneurysm is gone, but so is the parent vessel.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 ¿nv ¿ stent deformed¿.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient parent vessel stenosis¿, ¿patient abnormal imaging finding¿ and ¿patient stroke¿, 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 device was successfully implanted from proximal right mca (middle cerebral artery) to supraclinoid segment of right ica (internal carotid artery).19 days post flow diverter stent placement procedure, the patient experienced stroke like symptoms and was admitted to hospital for evaluation.Computed tomography angiography (cta) and magnetic resonance angiogram (mra) were performed showing narrowing of implanted device.Patient then had followed up angiogram showing severe stenosis of vessel.Oral steroids and additional anticoagulation were administered to the patient.Per physician¿s opinion, stroke, severe stenosis of vessel and deformation of implanted device were caused by potential nickel allergy/allergic reaction to something in the subject flow diverter device.Patient current condition is stable, but carotid has completely shut down (aneurysm is gone, but so is the parent vessel).

• Brand Name: SURPASS EVOLVE 3.25MM X 15MM - 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: 14960040
• Report Number: 3008881809-2022-00332
• Device Sequence Number: 6953310
• Product Code: OUT
• UDI-Device Identifier: 07613327375152
• UDI-Public: 07613327375152
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 10/05/2022

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: FDS32515
• Device Catalogue Number: FDS32515
• Device Lot Number: 24436447
• 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: 09/15/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 10/05/2022
• 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: Hospitalization; Other
• Patient Age: 61 YR
• Patient Sex: Female