MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number MV-01503HTDA

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/14/2019

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 microcatheter and the proximal section of the pusher were returned for evaluation.The implant and the distal section of the pusher were not returned for evaluation.The proximal portion of the pusher was severed at the transition between the hypotube and the pusher body coil, and all components distal from the break were not returned.The hypotube was found to be bent, which is indicative of the device experiencing forces over specification.The lumen of the returned microcatheter was inspected and no other coil components were provided.A review of the pusher's break location determined the break was likely caused by a shear or cutting force rather than tensile forces.The cross-section of the break shows the coil wire, and both yellow and green lead wires.These three components were severed in the same location, which occurs due to a cutting or shear force; a profile that is indicative of a tensile failure will most likely have these components fail in different or random locations, as seen in a control sample that was pulled to failure for comparison.The reported complaint is non-verifiable.The complaint stated that the coil became stuck in the microcatheter and detached in the microcatheter when the user attempted to retract the system.Only the proximal section of the pusher was returned for evaluation and was found to be severed at the hypotube/body coil transition.The break at this location appears to be the result of a shear or cutting force rather than the expected tensile failure that would result from retraction forces.The distal section of the pusher (including the implant) were not returned for evaluation, so the investigation could not confirm if the device failed or separated at another location(s).The investigation could only confirm that the pusher was broken, but the analysis of the break does not align with the reported complaint.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that when an embolization coil was being deployed in an aneurysm, the coil became stuck in the microcatheter.The implant coil detached in the microcatheter when it was being withdrawn.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or intervention.

• Brand Name: HYPERSOFT 3D ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: morgan holody ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 8933170
• MDR Text Key: 155649639
• Report Number: 2032493-2019-00201
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987350984838
• UDI-Public: (01)04987350984838(11)181203(17)231130(10)1812035XT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: MV-01503HTDA
• Device Lot Number: 1812035XT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 08/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1