MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STREAMLINE 3.0MM X 25MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003102FPP0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Stroke/CVA (1770); Headache (1880); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history record confirmed that the device met all material, assembly and performance specifications.The device was not returned, therefore physical as well as function analysis of the device was not performed.The reported patient stroke and patient serious headache are known and anticipated complication to these types of procedures and patient condition, and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complications has been assigned to the reported event.The subject device remains implanted inside patient.

Event Description

It was reported that nineteen-month post procedure, the patient experienced ongoing right-sided headache which was not resolved with pain relief and the headache was along with strange sensation.In addition, the ct (computed tomography) imaging showed infarct.The symptom was resolved without sequelae with the treatment of in-patient hospitalization.No further information is available.

Manufacturer Narrative

Additional information received on 9-feb-2021 reported that based on the cec (clinical events committee) review, the ae6 which included the ongoing headache and infarct image were not related to the procedure, implant or the surpass delivery system.Therefore, there is no complaint against the subject device.The manufacturer has reviewed all information and determined this event no longer meets the requirement of a reportable event for the subject device.

Event Description

It was reported that nineteen-month post procedure, the patient experienced ongoing right-sided headache which was not resolved with pain relief and the headache was along with strange sensation.In addition, the ct (computed tomography) imaging showed infarct.The symptom was resolved without sequelae with the treatment of in-patient hospitalization.No further information is available.Update: additional information received on 9-feb-2021 reported that based on the cec (clinical events committee) review, the ae6 which included the ongoing headache and infarct image were not related to the procedure, implant or the surpass delivery system.

• Brand Name: SURPASS STREAMLINE 3.0MM X 25MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 10059906
• MDR Text Key: 191071466
• Report Number: 3008881809-2020-00149
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2019
• Device Catalogue Number: M003102FPP0
• Device Lot Number: 19045927
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 53 YR