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

Model Number	W5-7-5
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances 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 is in transit to be returned to the manufacturer for evaluation but has not yet been received by the manufacturer.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: device w5-7-5 was too large for the aneurysm and could not be resheathed into the via 90 microcatheter.Used smaller device w5-7-4 instead.Procedure completed without incident.The w5-7-5 was removed by retracting it partially into the via 17 microcatheter.This made it small enough to be removed.It was pulled back into a benchmark guide catheter and removed from patient.A via 17, 45 degree tip microcatheter was used with the smaller device w5-7-4.No patient injury reported.
Additional Manufacturer Narrative
Items returned for evaluation: delivery system (pusher); web implant; via 17 microcatheter.The web device was returned within the microcatheter.The microcatheter was not found to be damaged.During the investigation, the web implant was successfully advanced and resheathed into the returned microcatheter without difficulty.Inspection found the web device to be in good condition with no observable damage and the web implant was measured and found to be within specifications.The investigation of the returned web system found the web implant to be in good shape, and within dimensional specification.Furthermore, the web implant was able to be advanced and resheathed into the returned microcatheter without difficulty during functional testing.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.The microcatheter used with the web system in the procedure was not found damaged and would not have caused or contributed to the reported complaint.
Event or Problem Description
As reported: device w5-7-5 was too large for the aneurysm and could not be resheathed into the via 90 microcatheter.Used smaller device w5-7-4 instead.Procedure completed without incident.The w5-7-5 was removed by retracting it partially into the via 17 microcatheter.This made it small enough to be removed.It was pulled back into a benchmark guide catheter and removed from patient.A via 17, 45 degree tip microcatheter was used with the smaller device w5-7-4.No patient injury reported.
Additional Manufacturer Narrative
Based on further review of the event, the event is deemed not reportable as it is likely to cause or contribute to a death or serious patient injury should the event recur.Therefore, mvi no longer considers this event a reportable malfunction event.
Event or Problem Description
As reported: device w5-7-5 was too large for the aneurysm and could not be resheathed into the via 90 microcatheter.Used smaller device w5-7-4 instead.Procedure completed without incident.The w5-7-5 was removed by retracting it partially into the via 17 microcatheter.This made it small enough to be removed.It was pulled back into a benchmark guide catheter and removed from patient.A via 17, 45 degree tip microcatheter was used with the smaller device w5-7-4.No patient injury reported.

• Brand Name: WEB SL
• Common Device Name: 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: 19774656
• Report Number: 2032493-2024-00553
• Device Sequence Number: 8654696
• Product Code: OPR
• UDI-Device Identifier: 00842429110942
• UDI-Public: (01)00842429110942(11)230620(17)280531(10)0000378998
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: W5-7-5
• Device Lot Number: 0000378998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 08/12/2024; Not provided
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/12/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIA 90 MICROCATHETER.
• Patient Sex: Unknown