MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-18-AV; VASCULAR EMBOLIZATION DEVICE

Model Number	181139HFRM-V-A2
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
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 has not yet been returned to the manufacturer for analysis.The alleged product issue cannot be confirmed.The instructions for use (ifu) identifies premature coil detachment and difficult or delayed coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during a coil embolization, the coil did not detach.The coil became stuck in the microcatheter upon withdrawl and the delivery pusher broke.The device was successfully removed with a snare after approximately two and a half hours.There was no reported patient injury.
Additional Manufacturer Narrative
The device was returned for evaluation.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The device was received broken into two parts at the transition.The uv glue bonds on the device were inspected and measured to be within spec.The implant was received with damaged loops and was still attached to the pusher with no signs of activation on the heater coil.Due to the broken pusher, resistance and continuity testing could not be performed to determine if it caused the non-detachment issue as described in the complaint.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.

• Brand Name: HYDROFRAME-18-AV
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11509977
• Report Number: 2032493-2021-00075
• Device Sequence Number: 3844471
• Product Code: HCG
• UDI-Device Identifier: 00816777023827
• UDI-Public: (01)00816777023827(11)200729(17)250630(10)2007295P7
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K100454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 06/30/2025
• Device Model Number: 181139HFRM-V-A2
• Device Catalogue Number: 181139HFRM-V
• Device Lot Number: 2007295P7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 03/17/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention