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

Model Number	100310HFRM-V-3D-A2
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the coil prepped as per ifu.The coil deployed in aneurysm through the microcatheter.Coil detached using a coil detacher (t marker alignment) with no apparent issue.The coil pusher was being removed under fluoroscopy, when slight resistance was felt by physician and then noted that pusher was being removed but 3cm marker not moving indicating that it has separated from the coil pusher.The microcatheter was removed under fluoroscopy but small tail of coil (approx.4mm) has come away from coil mass into parent artery.No, additional treatment occurred.The coil tail was observed for 10mins to check for any fresh clot, but none was seen.The patient was commenced on 2 one off doses of enoxaparin and started aspirin the next morning with a view of continuing aspirin for 6 weeks.The patient is stable.
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 ancillary device was 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
See h10.
Additional Manufacturer Narrative
Two radiographic images were provided for review.They are not labeled as to date or time.The review of the images is as follows: qper-1518c: 3d angio of left ica.There is a small acom aneurysm measuring about 2.5 x 3.5 mm, with an approximately 2 mm neck.Qper-1518b: left ica dsa, subtracted, with contrast, ap oblique projection.A coil mass is seen inside the aneurysm.A short coil tail (about 3 mm) extends from the coil mass to the a1 segment.More projections would be needed to determine the relationship of the coil mass to the neck of the aneurysm.No thrombus is seen.These images confirm that a coil tail does extend out of the into the parent artery as described in the reported evet; however, the images do not explain why the problem that is described in the complaint occurred.The investigation of the returned coil system found the pusher stretched and broken at the transition area and the distal portion of the pusher stuck inside the microcatheter upon receipt.The pusher heater coil was found burnt, which indicates thermal detachment did occur.Further investigation found the pusher's monofilament profiled a mushroom shape, which also indicates the implant successfully experienced thermal detachment.The implant was not returned for evaluation as it was detached as described in the reported event.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 microcatheter used with the coil system in the procedure was found to be flattened at 12cm from the distal tip, which may have caused or contributed to the resistance noted by the physician when attempting to remove the pusher.The returned detachment controller was found to function as intended and would not have caused or contributed to the reported event.

• Brand Name: HYDROSOFT-3D-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• 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: 19767837
• Report Number: 2032493-2024-00551
• Device Sequence Number: 8778539
• Product Code: HCG
• UDI-Device Identifier: 00816777026590
• UDI-Public: (01)00816777026590(11)231113(17)281031(10)0000461030
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100310HFRM-V-3D-A2
• Device Lot Number: 0000461030
• Was Device Available for Evaluation?: No
• 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: 06/24/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/13/2023
• 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
• Patient Sex: Unknown