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

Model Number	100310HFRM-V-3D-A2
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Malfunction
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 returned to the manufacturer for evaluation.The investigation is currently underway.The instructions for use (ifu) identifies premature and difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during coil embolization of an internal carotid artery aneurysm, the coil did not detach.During the removal attempt, the implant coil stretched and detached within the blood vessel due to allegedly forceful removal.No additional intervention was performed and there was no reported patient injury.The current patient's condition is reported to be "normal.".
Additional Manufacturer Narrative
The delivery pusher was received for evaluation.The implant coil was detached from the pusher and was not returned.The pusher's monofilament displayed evidence that the implant coil detached due to forces that exceeded the tensile strength of the monofilament.As the implant was not returned, the alleged coil stretching cannot be verified.

• Brand Name: HYDROSOFT 3D
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10844687
• Report Number: 2032493-2020-00331
• Device Sequence Number: 3732732
• Product Code: KRD
• UDI-Device Identifier: 00816777026590
• UDI-Public: (01)00816777026590(11)200326(17)250228(10)2003265W6
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Model Number: 100310HFRM-V-3D-A2
• Device Catalogue Number: 100310HFRM-V
• Device Lot Number: 2003265W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2020
• Initial Date Received by Manufacturer: 10/18/2020
• Supplement Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 11/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 70