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 Ruptured Aneurysm (4436)

Event Type  Injury  

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.

Event Description

As reported through the article titled, "retreatment strategies in aneurysm woven endobridge recurrences: a case series" a patient with no significant medical history presented with waxing and waning headaches for 2 weeks.Ct of the head showed a thick sah in the right sylvian fissure.Cerebral angiography confirmed a ruptured right-sided 5 x 3 mm middle cerebral artery (mca) aneurysm which was treated with a web sl device 4 x 3.A 6-month follow-up mra showed complete occlusion of the aneurysm.The patient was then lost to follow-up and presented 16 months later with severe headache.Ct of the head showed acute intraparenchymal hemorrhage in the right sylvian fissure.The patient was found to have a ruptured, recurrent, superiorly pointing 8 x 5mm right mca aneurysm that was coil embolized; the patient was then taken for a decompressive hemicraniectomy in anticipation of cerebral edema.The patient was discharged to rehabilitation and is scheduled for a later 6- month follow-up angiogram.The period of time reported for the cases and follow-up were 2015 through january 2021.

• 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: 14049190
• MDR Text Key: 288877313
• Report Number: 2032493-2022-00131
• 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: 57 YR
• Patient Sex: Male