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

Model Number W5-3.5-2-MVI

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance associated with this 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 implanted and therefore not available for return and investigation by the manufacturer.Procedural or medical imaging were not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.If imaging or additional information is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature web detachment as a potential complication associated with the use of the device.

Event Description

It was reported, acom aneurysm-treatment with a web device was performed / sah bleeding.There was normal vessel tortuosity.Previous connectivity check with wdc-2 was successful.The web was introduced and placed inside the aneurysm, but detachment attempts were unsuccessful with multiple controllers.The physician decided to re-sheath the web and while trying to re-sheath the web device, it unexpectedly detached.No patient harm or injury was reported.

Manufacturer Narrative

Items returned for evaluation: -delivery system (pusher).-via 17 microcatheter.Items not returned for evaluation: -web implant.-introducer.-dispenser hoop.-controller.The visual analysis of the returned items found the implant to be separated from delivery system and the implant was not returned for evaluation (img a).The hypotube was found kinked at the hypotube to connector junction (img b), and the proximal connector was kinked at the brown lead wire joint (img c).Tested the returned device with an in-house controller and gave red lights.The delivery system resistance was measured to be ol [ ] (spec= 66-78[ ]), which is out of specification due to the connector damage.The heater coil section was dissected to investigate any obstruction that could possibly prevent the implant from detaching, and the heater coil was found to be stretched which is 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 (img d).Although, the device failed the continuity and resistance testing due to the kinked connector; the heater coil did show signs of controller activation as indicated by the melted pet (img d).The heater coil winding damage likely also contributed to the failed continuity and resistance testing.No damage was found on the returned microcatheter.Investigation conclusion the reported complaint is confirmed.The investigation of the returned web system found the implant separated from the delivery system, the hypotube kinked, 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 and connector 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 delivery system damage, but the damage is consistent with the device experiencing forces over specification.

Event Description

Additional information received from the representative who originally reported the complaint, that stated the web detachment location is the acom-aneurysm, and the detached occurred in its intended location.No intervention used during this incident and the patient is ok.

• Brand Name: WEB SL
• Type of Device: INTRASACCULAR DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18341284
• MDR Text Key: 330874686
• Report Number: 2032493-2023-01123
• Device Sequence Number: 1
• Product Code: OPR
• UDI-Device Identifier: 00842429102039
• UDI-Public: (01)00842429102039(11)230104(17)271231(10)0000304506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: W5-3.5-2-MVI
• Device Lot Number: 0000304506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: VIA-17 MICROCATHETER; WDC-2 DETACHMENT CONTROLLER