MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR FLOW DISRUPTION DEVICE

Device Problems Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Aneurysm (1708)

Event Type  Injury  

Event Description

As reported through the article titled, "how to web: a practical review of methodology for the use of the woven endobridge", a patient with a prior history of subarachnoid hemorrhage caused by rupture of a posterior communicating artery aneurysm presented for web treatment of an enlarging unruptured basilar apex aneurysm.The post-deployment native digital subtraction angiogram (dsa) demonstrated adequate positioning of the web sl within the aneurysm.The post-detachment native dsa, however, demonstrated a change in orientation of the deployed web device causing mild impingement of the left posterior cerebral artery.A decision was made to deploy a lvis stent to protect the left posterior cerebral artery.The post deployment flat panel cone- beam ct with reconstruction of the lvis stent showed the web device within the aneurysm and patent lvis stent spanning from the left posterior cerebral artery into the basilar artery.

Manufacturer Narrative

The device lot number was not provided; therefore, a device history record and non-conformances could not be performed.The device remains implanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies device migration as a potential complication associated with use of the device.Bibliography: goyal, nitin, et al."how to web: a practical review of methodology for the use of the woven endobridge." journal of neurointerventional surgery 12.5 (2020): 512-520.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR FLOW DISRUPTION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14108160
• MDR Text Key: 289739470
• Report Number: 2032493-2022-00149
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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