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

Model Number 100256HS3D-V-A2

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 coil detachment as a potential complication associated with use of the device.

Event Description

It was reported that during a coil embolization of an aneurysm, the coil encountered some resistance within the microcatheter.The coil stretched and detached within the microcatheter during positioning.The coil system and microcatheter were removed together without incident.The patient was reported in good condition.There was no reported patient injury or sequela.

Manufacturer Narrative

The results of the investigation are ongoing and dependent on the investigation of a concomitant device.

Manufacturer Narrative

The investigation of the returned coil system found the pusher and implant to be severely stretched and broken.The returned headway 17 microcatheter was investigated under x-ray and found the broken distal end of the pusher stuck inside with a part of the stretched implant coil.During the investigation of the returned microcatheter, the distal end of the pusher was carefully removed and found the marker band to be attached to the pusher's heater coil with dry blood contamination.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: MICROPLEX HYPERSOFT 3D VTA
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11682605
• MDR Text Key: 246498152
• Report Number: 2032493-2021-00136
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777021069
• UDI-Public: (01)00816777021069(11)190926(17)240831(10)1909265WT
• Combination Product (y/n): N
• PMA/PMN Number: K131948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100256HS3D-V-A2
• Device Lot Number: 1909265WT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2021
• Date Manufacturer Received: 05/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Weight: 75