MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 4.0MM X 50MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003114FPP0

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

Patient Problem Stenosis (2263)

Event Date 02/16/2022

Event Type  Injury  

Event Description

It was reported that right ica (internal carotid artery) c4 segment flow diverter implantation was performed.Post operative follow-up revealed stenosis in subject flow diverter stent (stenosis rate: 1-25%) and parent artery stenosis (stenosis rate: 26-50%).Preoperative and postoperative antiplatelet therapy was performed according to the dosage schedule.Aspirin 100mg/day was giving to the patient from (b)(6) 2022, to now (ongoing).Patient was on clopidogrel 75mg/day for the time period of (b)(6) 2022 to (b)(6) 2022.Now patient is taking prasugrel 3.75mg/day from (b)(6) 2022 to now (ongoing).Patient condition and any other medical intervention performed due to this event is unknown.No other information is available.

Manufacturer Narrative

The device is not available to the manufacturer, as device was implanted in the patient.

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, 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 post procedure.1: stenosis in flow diverter stent (stenosis rate: (b)(4)) and 2: parent artery stenosis (stenosis rate: (b)(4)).The reported event of 'patient parent vessel stenosis' is a 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 of patient parent vessel stenosis.

Event Description

It was reported that right ica (internal carotid artery) c4 segment flow diverter implantation was performed.Post operative follow-up revealed stenosis in subject flow diverter stent (stenosis rate: (b)(4)) and parent artery stenosis (stenosis rate: (b)(4)).Preoperative and postoperative antiplatelet therapy was performed according to the dosage schedule.Aspirin 100mg/day was giving to the patient from (b)(6) 2022, to now (ongoing).Patient was on clopidogrel 75mg/day for the time period of (b)(6) 2022 to (b)(6) 2022.Now patient is taking prasugrel 3.75mg/day from (b)(6) 2022 to now (ongoing).Patient condition and any other medical intervention performed due to this event is unknown.No other information is available.

• Brand Name: SURPASS STREAMLINE 4.0MM X 50MM - 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: 13972523
• MDR Text Key: 288373030
• Report Number: 3008881809-2022-00148
• 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: 05/26/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2023
• Device Catalogue Number: M003114FPP0
• Device Lot Number: 22572811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/29/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 44 KG