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

Model Number W5-4-2-MVI-3

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2021

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains impanted in the patient; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies migration or misplacement as potential complications associated with use of the device.

Event Description

It was reported that the web device was used for treatment of a pre-ruptured acomm aneurysm.The aneurysm re-ruptured after web deployment.An angiogram run showed the aca was shut down and the web was protruding into the left a1.At that point bp was 144/37 from 120/55 when stent first detached.Bp pumped up with 2 boluses of iv integrilin and heparin 10,000 units.The physician attempt to aspirate with a catheter without success and a lvis jr.Stent was placed with good opposition against the wall to completed the procedure.The patient current condition described as "patient is good".

• 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: 13054750
• MDR Text Key: 284209719
• Report Number: 2032493-2021-00512
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429110812
• UDI-Public: (01)00842429110812(11)210917(17)240831(10)0000085474
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: W5-4-2-MVI-3
• Device Catalogue Number: W5-4-2
• Device Lot Number: 0000085474
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2021
• 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: 37 YR
• Patient Sex: Male
• Patient Weight: 98 KG