MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7310-1030-A2
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that as the coil was being placed in a patient, it was determined to not be in the correct position for deployment.The physician attempted to retrieve the device; however, while removing the device, the coil become detached, or stretched to the point that the coil was not successfully removed from the body and remained in the coil mass with a "tail" in the patient¿s native anatomy.The coil and the delivery catheter were removed.The physician went to cross the aneurysm neck with a traxcess wire; however, it subsequently got stuck somewhere within the prior stent or coil tail.This wire was then twisted until the distal tip broke off and remained in the patient, the remainder of the wire was removed.The coil was reported to be in the parent artery post procedure; thus, intervention with a stent was performed.The patient was reported to be doing good.This report addressed the coil used in the case.
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 device was stated to be available for return to the manufacturer for evaluation, but has not yet been returned.The detached coil and tail in the parent artery 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.The instructions for use (ifu) identifies coil migration or misplacement, and premature or difficult coil detachment as potential complications associated with use of the device.

• Brand Name: HYDROFILL-10-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• 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: 16474748
• Report Number: 2032493-2023-00592
• Device Sequence Number: 15323906
• Product Code: HCG
• UDI-Device Identifier: 00816777023452
• UDI-Public: (01)00816777023452(11)211216(17)261130(10)0000138350
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K112226
• 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
• Report Date (Section B): 02/13/2023

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: 7310-1030-A2
• Device Lot Number: 0000138350
• 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: 02/13/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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