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

Catalog Number FDS40020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Visual Disturbances (2140); Shaking/Tremors (2515); Convulsion/Seizure (4406); Presyncope (4410)

Event Date 03/13/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported that during a procedure using the subject flow diverter in a clinical trial, the patient experienced abnormal movement of bilateral upper and lower extremities, head shaking & turned to the right side, no loss of consciousness and mild tachycardia.Ct imaging on day of event showed no acute intracranial hemorrhage or mass effect.The procedure was reported to have been completed successfully with the subject flow diverter stent and no device deficiencies were noted.Site reported medical history confirmed the patient had diabetes and a bmi of (b)(6) and the event may have been related to hyperglycemia and dehydration.Site rationale for event is possible effects of anesthesia during procedure.Cec assessed as possible focal seizure.No other information is available.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.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.Per site reporting, the procedure was completed in 6min and the evolve stent was implanted successfully with no device deficiencies noted.The imr (designated cec member) commented on the bilateral limb shaking event, head turning, no loss of consciousness as possible focal seizure.The site report medical history confirms the subject has diabetes and a bmi of 31.8.Per site reporting in edc, ct imaging on day of event shows no acute intracranial hemorrhage or mass effect.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 'nv - 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 within the directions for use, product labelling and/or risk documentation files.

Event Description

It was reported that during a procedure using the subject flow diverter in a clinical trial, the patient experienced abnormal movement of bilateral upper and lower extremities, head shaking & turned to the right side, no loss of consciousness and mild tachycardia.Ct imaging on day of event showed no acute intracranial hemorrhage or mass effect.The procedure was reported to have been completed successfully with the subject flow diverter stent and no device deficiencies were noted.Site reported medical history confirmed the patient had diabetes and a bmi of 31.8 and the event may have been related to hyperglycemia and dehydration.Site rationale for event is possible effects of anesthesia during procedure.Cec assessed as possible focal seizure.No other information is available.

Event Description

It was reported that during a procedure using the subject flow diverter in a clinical trial, the patient experienced abnormal movement of bilateral upper and lower extremities, head shaking & turned to the right side, no loss of consciousness and mild tachycardia.Ct imaging on day of event showed no acute intracranial hemorrhage or mass effect.The procedure was reported to have been completed successfully with the subject flow diverter stent and no device deficiencies were noted.Site reported medical history confirmed the patient had diabetes and a bmi of 31.8 and the event may have been related to hyperglycemia and dehydration.Site rationale for event is possible effects of anesthesia during procedure.Cec assessed as possible focal seizure.No other information is available.It was reported that post procedure with the subject flow diverter on (b)(6) 2021 patient experienced abnormal movement of bilateral upper and lower extremities, head shaking & turned to the right side, no loss of consciousness and mild tachycardia related to hyperglycemia and dehydration.The event was reported as recovered/resolved on (b)(6) 2021.It was reported that in a clinical trial procedure, the subject flow diverter was used in the left internal carotid artery-ophthalmic (c6 segment) to treat a saccular aneurysm measuring 8.72mm on (b)(6) 2021.Post procedure on (b)(6) 2021, the patient had visual disturbances (blurred vision and vision loss) in the left eye which were treated by administering clopidogrel.The event was reported as recovered/resolved on (b)(6) 2021.The event was reported as possibly related to the subject device by the site.

Manufacturer Narrative

B5 executive summary: updated.D1 catalog #, product long description: corrected.D6a date of implant : corrected.H2 if follow-up, type : updated.The adverse event "visual disturbances (blurred vision and vision loss) in the left eye" was previously reported in mfr report # 3008881809-2022-00007.Upon further review it was confirmed that the subject device was used on the same event date, in the same case, and on the same patient.The second event of "visual disturbances (blurred vision and vision loss) in the left eye" reported for the same patient is investigated under report mfr report # 3008881809-2021-00254.Due to the automated mes system 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.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 event description states "blurred vision left eye.Stent was placed over the left ophthalmic artery and the temporary vision loss was in the left eye".Per site reporting, the procedure was completed in 6min and the subject stent was implanted successfully with no device deficiencies noted.The imr (designated cec member) commented on the bilateral limb shaking event, head shaking ,no loss of consciousness as possible focal seizure.The site report medical history confirms the subject has diabetes and a bmi (body mass index) of 31.8.Per site reporting, ct (computerized tomography) imaging on day of event shows no acute intra cranial hemorrhage or mass effect.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 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 within the directions for use, product labelling and/or risk documentation files.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - PMAS
• Type of Device: 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: 12000998
• MDR Text Key: 256262582
• Report Number: 3008881809-2021-00254
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: FDS40020
• Device Lot Number: 22622681
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other