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

Model Number 100308HS3D-V-A2

Device Problem Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  malfunction  

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 investigation of the returned coil system found the implant broken and to be attached to the pusher.Burn marks were found on the pusher's heater coil indicating the device was activated using a detachment controller.Replication testing was performed using a compatible lab provided introducer sheath and microcatheter resulting in heavy resistance/friction, which is consistent with the damage found on the device.The unit passed continuity and resistance testing, and the implant was successfully detached during testing.The stretching and fracture of the implant is consistent with the device experiencing tensile (i.E.Retraction) forces that exceeded the strength of the coil's wire.The microcatheter used in the procedure was not evaluated as a part of this evaluation; therefore, the investigation could not determine if it had caused or contributed to the reported complaint.The instructions for use (ifu) identifies difficult coil detachment and premature coil detachment as potentials complications associated with use of the device.

Event Description

It was reported that the embolization coil unexpectedly detached in the microcatheter during withdrawal after non-detachment.The coil believed may have had stretched.The coil was pushed to position using a guidewire.There was no report of injury to the patient, whose condition reported to be "normal.".

• Brand Name: MICROPLEX HYPERSOFT 3D VTA
• Type of Device: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12097096
• MDR Text Key: 259397896
• Report Number: 2032493-2021-00261
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00816777026750
• UDI-Public: (01)00816777026750(11)171219(17)221130(10)1712195Y6
• Combination Product (y/n): N
• PMA/PMN Number: K131948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: 100308HS3D-V-A2
• Device Lot Number: 1712195Y6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2021
• Date Manufacturer Received: 06/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 56