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

Model Number	7110-0310-3D-A2
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Serious Injury
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 embolization coil remains implanted in the patient and the delivey system was discarded.Procedure images were provided and their review is underway.At this time, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during an aneurysm embolization procedure, the coil was deployed as the third and final coil.Multiple deployment and re-sheathing attempts were made when the physician noted the coil file stretched and detached.Ultimately it seemed the coil detached with a long tether remaining proximal to the end of the coil.The proximal 1-2cm of coil were left out of the aneurysm with an additional portion left proximal to the lvis jr.Stent, which had already been deployed, jailing the microcatheter being used to coil.As well, this remaining tether (of around 5-10cm) was left proximal to the lvis jr.And ultimately tacked down with an atlas stent, proximal to the original coil/stent construct.Multiple attempts at clearing the microcatheter with a guidewire failed to dislodge the tether, which was still in the microcatheter.A snare was also utilized around the microcatheter in order to snare the tether or coil to remove it, however, the snare would not navigate the anatomy and could not reach the site.Ultimately it was decided to tack down the tail with an atlas stent.The patient is doing well at end and post of procedure.No further treatment performed.
Additional Manufacturer Narrative
Summary image review: no product(s) were returned for evaluation, but six images were provided.Three photographs of a microcatheter (sl-10, from the report) show no indication of the alleged coil tether remaining inside the microcatheter; however, the distal tip appears to be slightly deformed.Three coned-down unsubtracted radiographs of the central portion of the skull show a coil mass in what appears to be a basilar tip aneurysm (from the location, no contrast has been injected in the artery).An atlas stent extends from the right p1-p2 segment, across the coil mass, proximally to the mid-basilar artery.A straight coil extends out from the coil mass proximally to the level of the mid-basilar artery.Another atlas stent is seen in the ap projection, likely in the distal right vertebral artery.These images confirm the complaint and show the stretched coil extending out from the aneurysm proximally to the level of the mid-basilar artery.Without the return and physical evaluation of the device, the investigation is unable to 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: 13662184
• Report Number: 2032493-2022-00074
• Device Sequence Number: 19318719
• Product Code: KRD
• UDI-Device Identifier: 00816777025487
• UDI-Public: (01)00816777025487(11)190321(17)240229(10)1903211W6
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K080666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/01/2022

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 Expiration Date: 02/29/2024
• Device Model Number: 7110-0310-3D-A2
• Device Catalogue Number: 7110-0310
• Device Lot Number: 1903211W6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2019
• 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: LVIS JR. STENT.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 77 KG