MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT 3D VTA; VASCULAR EMBOLIZATION DEVICE

Model Number	100310HFRM-V-3D-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance's 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 investigation of the returned coil system found the pusher broken at transition and the implant severely stretched at proximal with deformed distal loops.Replication testing was not performed to determine the cause of the reported complaint due to the damages found on the returned device.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 retraction forces over specification.The instructions for use (ifu) identifies coil stretching and premature coil detachment as potentials complications associated with use of the device.
Event or Problem Description
It was reported that the embolization coil was used for treatment of unspecified aneurysm.When roughly 7cm of the coil was deployed in the aneurysm, resistance felt and the coil stretched.The pusher detached in the microcatheter during attempt to remove the coil.The coil was removed along with the microcatheter.Other coils were used to successfully complete the case.Patient is fine.

• Brand Name: MICROPLEX HYPERSOFT 3D VTA
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12315500
• Report Number: 2032493-2021-00325
• Device Sequence Number: 17265782
• Product Code: KRD
• UDI-Device Identifier: 00816777026590
• UDI-Public: (01)00816777026590(11)210420(17)260331(10)2104205P6
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K131948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 03/31/2026
• Device Model Number: 100310HFRM-V-3D-A2
• Device Catalogue Number: 100310HFRM-V
• Device Lot Number: 2104205P6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 08/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1