MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICAL HYPERSOFT; EMBOLIZATION COIL

Model Number 100204HS-V-N

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem Thrombus (2101)

Event Date 11/13/2018

Event Type  Injury  

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 has been returned to the manufacturer.The investigation is 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 coil embolization of an aneurysm, the implant coil did not detach.During withdrawal of the device, the coil unexpectedly detached.The detached implant coil was pushed into the aneurysm; however, a small part of the coil extended into the parent artery, which resulted in formation of thrombus.Integrilin was administered to lyse the thrombus.There was no reported adverse clinical sequela to the patient.

Manufacturer Narrative

Additional information: (if follow-up, what type) the product return did not include the actual device.Only ancillary devices were returned.Corrected data: (concomitant medical products) the product return did not include the actual device.Only ancillary devices were returned.The microcatheter and guidewire were received for analysis.The pusher, implant, introducer, and v-grip were not received.The microcatheter was found to be in good condition with no kinks or damage observed along its length.The guidewire was returned inside the microcatheter and found to be in good condition.Advancement with the guidewire in the microcathter was attempted and no resistance was encountered.The guidewire was successfully advanced through the distal end of the microcatheter.Based upon the investigation analysis and available information, the reported complaint is non-verifiable.The pusher and implant were not returned and therefore analysis of the reported complaint could not be completed.The evaluation of the microcatheter and guidewire did not find anything that caused or contributed to the reported complaint.

• Brand Name: MICROPLEX HYPERSOFT HELICAL HYPERSOFT
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8741130
• MDR Text Key: 149407217
• Report Number: 2032493-2019-00161
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425020036
• UDI-Public: (01)00811425020036(11)180713(17)230630(10)1807135YJ
• Combination Product (y/n): N
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 100204HS-V-N
• Device Lot Number: 1807135YJ
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Manufacturer Received: 05/28/2019
• Initial Date FDA Received: 06/27/2019
• Supplement Dates Manufacturer Received: 05/28/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention