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

Model Number	7110-0310-3D-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician was treating a basilar tip aneurysm with y stent and multiple coils.Initial coils inserted and implanted without issue.The 3x10 hydrosoft 3d coil partially deployed into aneurysm and the physician tried to re-sheath and re-deploy, but the coil prematurely detached inside the catheter.The coil was snared and removed from the patient.The procedure continued and successfully completed using a few more coils of different brand.There was no harm or injury to the patient, who reportedly was stable.
Additional 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 was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies premature or difficult coil detachment and stroke as potential complications associated with use of the device.
Additional Manufacturer Narrative
Summary device evaluation: the investigation of the returned coil system found the implant not returned, and separated from the pusher.No indication using a detachment controller was found on the pusher's 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.Two unsubtracted dsas with contrast of the right vertebral and basilar arteries are supplied, ap and lateral.They show a y-stent construct at the distal basilar bifurcation (probably atlas stents) with a well-packed medium-sized basilar tip aneurysm.The proximal end of a coil is outside the aneurysm and extends from it proximally to the level of the vertebrobasilar junction, where its looped, intact proximal end is visualized.No images are provided to show that the coil has been removed, as described in the report.The cause for the coil's premature detachment is not seen on the two images provided.The physical device was partially returned for evaluation, so the investigation could not determine if a condition existed that would have caused or contributed to the reported event.

• Brand Name: HYDROSOFT 3D-AV
• Common Device Name: 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: 14894324
• Report Number: 2032493-2022-00252
• Device Sequence Number: 20380291
• Product Code: KRD
• UDI-Device Identifier: 00816777025487
• UDI-Public: (01)00816777025487(11)220330(17)270228(10)0000175225
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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: 7110-0310-3D-A2
• Device Catalogue Number: 7110-0310
• Device Lot Number: 0000175225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 07/01/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown