MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS50020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Transient Ischemic Attack (2109); Loss of Vision (2139)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the subject device is implanted inside the patient's vasculature.
Event or Problem Description
It was reported that post procedure with the subject flow diverter patient experienced 2 episodes of loss of vision in left eye that lasted less than 15 min each since (b)(6) 2023.Presented to his local emergency room.Ct (computerized tomography) head, cta (computed tomography angiography) head and mri- (magnetic resonance imaging) head, all were noted to be normal.Ophthalmology consult ruled out central retinal artery occlusion.Subject admitted to hospital overnight for observation.Patient is put on medications aspirin increased to 325mg and restarted on plavix 75 mg for 21 days, started from (b)(6) 2023.Investigator plans for dsa (digital subtraction angiography) as soon as possible.It is reported that the subject flow diverter could have resulted in tia (transient ischemic attack) causing loss of vision in left eye.The reported adverse event outcome is indicated as not recovered/not resolved.It is reported that the adverse event is possibly related to the study device and an underlying condition or disease.The rationale for relationship to the study device was stated as "device could have resulted in tia causing loss of vision in left eye".
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 subject device is not available; therefore, visual testing as well as functional 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.Additional information indicates the subject experienced loss of vision in left eye for episodes lasting less than 15 min each.Computer tomography ct head, computer tomography angiography cta head and magnetic resonance imaging mri head, all normal.Ophthalmology consult ruled out central retinal artery occlusion.Subject admitted to hospital overnight for observation.Aspirin increased to 325mg and restarted on plavix 75 mg for 21 days.Investigator plans for digital subtraction angiography dsa as soon as possible.Clopidogrel 75mg/d was started from (b)(6) 2023.Device could have resulted in transient ischemic attack tia causing loss of vision in left eye.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient tia ( transient ischemic attack)¿ and ¿patient neurological deficit¿ 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 post procedure with the subject flow diverter patient experienced 2 episodes of loss of vision in left eye that lasted less than 15 min each since (b)(6) 2023.Presented to his local emergency room.Ct (computerized tomography) head, cta (computed tomography angiography) head and mri- (magnetic resonance imaging) head, all were noted to be normal.Ophthalmology consult ruled out central retinal artery occlusion.Subject admitted to hospital overnight for observation.Patient is put on medications aspirin increased to 325mg and restarted on plavix 75 mg for 21 days, started from 10/3/2023.Investigator plans for dsa (digital subtraction angiography) as soon as possible.It is reported that the subject flow diverter could have resulted in tia (transient ischemic attack) causing loss of vision in left eye.The reported adverse event outcome is indicated as not recovered/not resolved.It is reported that the adverse event is possibly related to the study device and an underlying condition or disease.The rationale for relationship to the study device was stated as "device could have resulted in tia causing loss of vision in left eye".

• Brand Name: SURPASS EVOLVE 5.0MM 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: 18016425
• Report Number: 3008881809-2023-00518
• Device Sequence Number: 20467519
• Product Code: OUT
• UDI-Device Identifier: 07613327375299
• UDI-Public: 07613327375299
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 12/11/2023

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: 12/01/2023
• Device Catalogue Number: FDS50020
• Device Lot Number: 22622270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 27 YR
• Patient Sex: Male