MAUDE Adverse Event Report: MICROVENTION, INC. WEB SL; INTRASACCULAR DEVICES

Model Number W5-4.5-3-MVI

Device Problem Difficult or Delayed Separation (4044)

Patient Problem Intracranial Hemorrhage (1891)

Event Date 10/12/2023

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 was available but has not been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies difficult or delayed detachment as potential complications associated with use of the device.The physician stated that the complications/death was not caused by the difficulties during detachment, but with the sah followed by severe vasospasm and furthermore the severe cardiac events.

Event Description

It was reported, acom aneurysm-treatment with a web device was performed / sah bleeding h&h 2.Previous connectivity check with wdc-2 was successful.The web was introduced and placed inside the aneurysm, but detachment unsuccessful.The physician tried several times and switched to another wdc-2, after some mechanical manipulation, bringing via17 over detachment zone and slightly pulling the pusher wire led to an successful detachment.Patient developed severe vasospasm due to the severe sah on oct 16th.Nimodipin therapy was initiated.Patient died on (b)(6)2023 due to coronary heart disease, cardiogenic shock and unsuccessful cardio-pulmonary reanimation.The physician stated that the complications/death was not caused by the difficulties during detachment, but with the sah followed by severe vasospasm and furthermore the severe cardiac events.

Manufacturer Narrative

The investigation of the returned web system found the implant separated from the delivery system, the proximal connector kinked, and the heater coil windings stretched.The implant was not returned for evaluation.The device failed continuity and resistance testing due to the damaged connector and heater coil windings.However, the heater coil pet was found melted, indicating that the device was activated using a detachment controller during the procedure; therefore, the damage to the heater coil windings likely occurred post-activation.The stretched heater coil windings are an indication that the tether could have been caught in between the coil windings and caused the heater coil to stretch when the delivery system was pulled/retracted during the procedure.The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher damage, but the damage is consistent with the device experiencing forces over specification.The returned detachment controllers were found to function as intended and would not have caused or contributed to the reported event.

Event Description

See h10.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR DEVICES
• 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: 18178589
• MDR Text Key: 328612138
• Report Number: 2032493-2023-01062
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102060
• UDI-Public: (01)00842429102060(11)220929(17)270831(10)0000263657
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-4.5-3-MVI
• Device Lot Number: 0000263657
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 12/16/2023
• Supplement Dates FDA Received: 12/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2022
• 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): Other