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

Model Number	100310HFRM-V-3D-A2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned.The premature detachment of the device 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.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 instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported the physician was treating a 10 mm ica top aneurysm with a stent and assisted coiling.He was using the last coil and when maneuvering it, observed that the coil had detached spontaneously.Since it was the last coil, the physician decided to remove it along with the microcatheter.Procedure was completed and the patient is stable, doing well.
Event or Problem Description
No additional information was received.Please see h6 and h10.
Additional Manufacturer Narrative
Items returned for evaluation: -pusher -implant -introducer -dispenser hoop items not returned for evaluation: -shrink lock -microcatheter -v-grip the coil system was returned with the introducer and loaded inside the dispenser hoop.Upon removing the device from the dispenser hoop, it was observed that the pusher was returned without the implant attached.The implant was returned separated from the pusher, and the coils were severely stretched.During the investigation, it was found that the pusher monofilament was broken, indicating that the device experienced a tensile break.The investigation of the returned coil system found the implant severely stretched and separated from the pusher; however, no indications of activation using a detachment controller was found on the pusher heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip, which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.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 instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16771705
• Report Number: 2032493-2023-00676
• Device Sequence Number: 17741953
• Product Code: HCG
• UDI-Device Identifier: 00816777026590
• UDI-Public: (01)00816777026590(11)220505(17)270430(10)0000189469
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091641
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2023

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: 100310HFRM-V-3D-A2
• Device Catalogue Number: 100310HFRM-V
• Device Lot Number: 0000189469
• 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: 04/08/2023
• Supplement Date Received by Manufacturer: 05/19/2023
• Initial Report FDA Received Date: 04/19/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 54 KG