MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL HELICAL 10 VTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100306HFIL-V-A2
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment of a recurrent acom aneurysm via stent assisted coiling, the coil did not detach with multiple attempts.It was decided to try and remove the coil from the aneurysm by withdrawing it into the hw duo.After withdrawing approximately 2cm of coil into the microcatheter the coil became jammed and could not be withdrawn further.The microcatheter was then attempted to be withdrawn from the sac along with the coil.Upon withdrawal of the microcatheter the coil was entangled within the coil mass and was unable to be cleanly removed.Retraction of the coil pusher resulted in partial separation of the pusher and appeared to delaminate the coil and a snare was eventually used to retrieve as much of the coil as possible.A small remaining filament tail remained from the aneurysm to the cavernous section of the left ica and this was stabilized and trapped against the wall with placement of a stent.The patient recovered to be discharged home.
Additional Manufacturer Narrative
A search for non-conformance 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 was returned to the manufacturer for evaluation and the investigation is currently underway.
Additional Manufacturer Narrative
A search for non-conformance 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 was returned to the manufacturer for evaluation and the investigation is currently underway.
Event or Problem Description
It was reported that during treatment of a recurrent acom aneurysm via stent assisted coiling, the coil did not detach with multiple attempts.It was decided to try and remove the coil from the aneurysm by withdrawing it into the hw duo.After withdrawing approximately 2cm of coil into the microcatheter the coil became jammed and could not be withdrawn further.The microcatheter was then attempted to be withdrawn from the sac along with the coil.Upon withdrawal of the microcatheter the coil was entangled within the coil mass and was unable to be cleanly removed.Retraction of the coil pusher resulted in partial separation of the pusher and appeared to delaminate the coil and a snare was eventually used to retrieve as much of the coil as possible.A small remaining filament tail remained from the aneurysm to the cavernous section of the left ica and this was stabilized and trapped against the wall with placement of a stent.The patient recovered to be discharged home.
Additional Manufacturer Narrative
Additional information: h3, h6, h10 (summary device evaluation).Summary of device evaluation: the investigation of the returned coil system found the pusher completed stretched and damaged with no implant attached at distal.The microcatheter used in the procedure was returned damaged with the hub broken at proximal.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.Detachment testing could not be performed due to the severity of the damage to the pusher, which is why the complaint is considered non-verifiable.

• Brand Name: HYDROFILL HELICAL 10 VTA
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terry callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13173709
• Report Number: 2032493-2022-00008
• Device Sequence Number: 4780699
• Product Code: HCG
• UDI-Device Identifier: 00816777023254
• UDI-Public: (01)00816777023254(11)190426(17)240331(10)1904261W5
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112226
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 12/08/2021

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: 03/31/2024
• Device Model Number: 100306HFIL-V-A2
• Device Catalogue Number: 100306HFIL-V
• Device Lot Number: 1904261W5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 01/06/2022
• Supplement Report FDA Received Date: 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male