MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 5.0MM X 30MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003121FPP0

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

Patient Problems Stroke/CVA (1770); Stenosis (2263); Speech Disorder (4415); Embolism/Embolus (4438)

Event Date 12/01/2021

Event Type  Injury  

Event Description

It was reported that left ica (internal carotid artery) c2 segment flow diverter implantation was performed in the patient with other relevant history of hyperlipidemia, osteoporosis.On the same day of procedure stenosis in subject flow diverter stent (stenosis rate: 1-25%) was noted.On the next day mri imaging was performed which revealed multiple micro embolism.The patient was reported to have stroke.According to the physician the stroke was non-serious but likely related to the procedure.Edaravone 30mg was administered twice a day for treatment of the stroke.On seventh of the procedure patient recovery was noted.Preoperative and postoperative antiplatelet therapy was performed according to the dosage schedule.Aspirin 100mg/day was giving to the patient from (b)(6) 2021, to now (ongoing).Patient was on clopidogrel 75mg/day for the time period of (b)(6) 2021 to (b)(6) 2021.Now patient is taking clopidogrel 5omg/day from (b)(6) 2022 (ongoing).The procedure was completed successfully.No other information is available.

Manufacturer Narrative

D.Suspect medical device: catalog no search - updated.D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes system 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.It was reported that 2 adverse events were noted.Adverse event 1: stenosis in flow diverter stent found on (b)(6), 2021 (stenosis rate: (b)(4)) adverse event 2: stroke found on (b)(6), 2021 (dysarthria was confirmed a day after the procedure.Mri showed multiple microembolus.The doctor judged that the stroke was non-serious but likely related to the procedure.) edaravone 30mg was administered twice a day for treatment of the stroke and it was reported that the patient recovered on (b)(6), 2022.The reported 'patient parent vessel stenosis', patient stroke and patient embolus are known and anticipated complication to these types of procedures and patient condition and are listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.

Event Description

It was reported that left ica (internal carotid artery) c2 segment flow diverter implantation was performed in the patient with other relevant history of hyperlipidemia, osteoporosis.On the same day of procedure stenosis in subject flow diverter stent (stenosis rate: (b)(4)) was noted.On the next day mri imaging was performed which revealed multiple micro embolism.The patient was reported to have stroke.According to the physician the stroke was non-serious but likely related to the procedure.Edaravone 30mg was administered twice a day for treatment of the stroke.On seventh of the procedure patient recovery was noted.Preoperative and postoperative antiplatelet therapy was performed according to the dosage schedule.Aspirin 100mg/day was giving to the patient from (b)(6) 2021, to now (ongoing).Patient was on clopidogrel 75mg/day for the time period of (b)(6) 2021 to (b)(6) 2021.Now patient is taking clopidogrel 5omg/day from (b)(6) 2022 (ongoing).The procedure was completed successfully.No other information is available.

• Brand Name: SURPASS STREAMLINE 5.0MM X 30MM - CE
• 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: 14060374
• MDR Text Key: 290164692
• Report Number: 3008881809-2022-00164
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170024
• 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
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Catalogue Number: M003121FPP0
• Device Lot Number: 22359217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2020
• 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): Required Intervention; Other
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 55 KG