MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D-AV; VASCULAR EMBOLIZATION DEVICE

Model Number MV-00202HTDA

Device Problems Detachment of Device or Device Component (2907); Separation Problem (4043); Difficult or Delayed Separation (4044)

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

Event Date 11/30/2021

Event Type  malfunction  

Event Description

It was reported that when the embolization coil was delivered into the aneurysm, it would not detach despite multiple attempts.During push and pull manipulation, the coil unintentionally detached and the coil was pushed into the aneurysm and implanted successfully.There was no report of harm or injury to the patient.

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 implanted in the patient; however, the delivery pusher is available but has not been received.At this time, the alleged product issue cannot be confirmed.If the pusher or additional information is received, mvi will submit a supplemental report.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

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 implanted in the patient; however, the delivery pusher is available but has not been received.At this time, the alleged product issue cannot be confirmed.If the pusher or additional information is received, mvi will submit a supplemental report.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that when the embolization coil was delivered into the aneurysm, it would not detach despite multiple attempts.During push and pull manipulation, the coil unintentionally detached and the coil was pushed into the aneurysm and implanted successfully.There was no report of harm or injury to the patient.

Manufacturer Narrative

The reported complaint is non-verifiable.The investigation of the returned coil system found the implant to be detached from the pusher.The pusher's electrical circuit was within specification, and the heater coil and monofilament had evidence of activation using a detachment controller.Coil systems are 100% inspected prior to release from manufacturing, and no energy is distributed to the heater coil during the manufacturing process.Therefore, it is likely that the device was activated during the procedure.The complaint is considered non-verifiable as the physical evaluation of the returned pusher is unable to verify the claim the exact detachment scenario described in the reported event.

• Brand Name: HYDROSOFT 3D-AV
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13056161
• MDR Text Key: 285237148
• Report Number: 2032493-2021-00513
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 04987350984876
• UDI-Public: (01)04987350984876(11)171017(17)220930(10)17101756W
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K080666
• 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: 11/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: MV-00202HTDA
• Device Lot Number: 17101756W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/21/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 02/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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