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

Model Number	100254HFRM-V
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 has been returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Event or Problem Description
As reported: fourth coil was deployed into ruptured aneurysm, could not get entire length of the coil into the aneurysm, approximately 1cm of coil remained protruding on each of 3 attempts.Increased friction felt manipulating coil in advanced straight microcatheter, so attempted to remove coil.However, the pusher wire of the coil snapped proximally.Distal fragment of coil and pusher wire were removed with a snare and the remaining tail of coil was stented in place to successfully complete the procedure.Surgical intervention in form of stent being deployed, however no adverse effects to patient noted as a result of this procedure.No change to mrs pre / post procedure.Procedure performed: acom aneurysm embolisation.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher.-introducer.Items not returned for evaluation: -implant.-shrink lock.-dispenser hoop.-microcatheter.The visual analysis of the returned device found the pusher returned broken at the transition area, the pusher hypotube kinked at the proximal section, and the proximal connector broken at the distal and proximal end.The distal portion of the pusher and the implant were not returned for evaluation.The investigation found the pusher returned broken at the transition area, the pusher hypotube kinked at the proximal section, and the proximal connector broken at the distal and proximal end, which is consistent with the alleged product issue.The distal portion of the pusher and the implant were not returned for evaluation.The broken condition of the pusher is consistent with the device experiencing force that exceeded the device's tensile strength, resulting in the pusher breaking.The physical evaluation of the device could not identify the conditions or circumstances that led to the hypotube kink, but the kink is consistent with the device experiencing forces exceeding the hypotube's yield strength.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
As reported: fourth coil was deployed into ruptured aneurysm, could not get entire length of the coil into the aneurysm, approximately 1cm of coil remained protruding on each of 3 attempts.Increased friction felt manipulating coil in advanced straight microcatheter, so attempted to remove coil.However, the pusher wire of the coil snapped proximally.Distal fragment of coil and pusher wire were removed with a snare and the remaining tail of coil was stented in place to successfully complete the procedure.Surgical intervention in form of stent being deployed, however no adverse effects to patient noted as a result of this procedure.No change to mrs pre / post procedure.Procedure performed: acom aneurysm embolisation.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• 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: 20313861
• Report Number: 2032493-2024-00717
• Device Sequence Number: 12763673
• Product Code: HCG
• UDI-Device Identifier: 00816777026538
• UDI-Public: (01)00816777026538(11)231002(17)280930(10)0000435730
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K103758
• 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
• Report Date (Section B): 10/07/2024

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
• Operator of Device: Health Professional
• Device Model Number: 100254HFRM-V
• Device Lot Number: 0000435730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2024
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2023
• 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: HEADWAY 17 ADVANCED STRAIGHT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown