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

Model Number UNKNOWN

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

Patient Problem Aneurysm (1708)

Event Type  Injury  

Event Description

As reported through the article titled, "retreatment strategies in aneurysm woven endobridge recurrences: a case series" a patient with an extensive medical history had an incidental finding of a right-sided mca aneurysm on ct angiography.The last imaging report was in 2007, and the aneurysm had since doubled in size.Cerebral angiography confirmed an 8.4 x 6.7mm right mca aneurysm, and it was embolized with a web sl device 9 x 4.A 7-month follow-up angiogram showed a 50% occlusion of the aneurysm because of web compaction; therefore, it was stent-coiled, and the final angiographic run showed adequate occlusion.On the 5-month follow-up angiogram, the patient was found to have a 3.5 x 3.9mm mca aneurysm recurrence, and the patient was recoiled.Another 6-month follow-up angiogram showed a stable 95% occlusion of the aneurysm.The period of time reported for the cases and follow-up were 2015 through january 2021.

Manufacturer Narrative

The device lot number was not provided; therefore, a device history record and non-conformances search could not be performed.The device remains implanted in the patient.The event as described cannot be confirmed.

• Brand Name: WEB
• 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: 14049213
• MDR Text Key: 288876094
• Report Number: 2032493-2022-00132
• Device Sequence Number: 1
• Product Code: OPR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2022

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 Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• 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
• Patient Age: 76 YR
• Patient Sex: Male