MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL SOFT; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100520HC-R-V-CN

Device Problems Stretched (1601); Premature Separation (4045)

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

Event Date 06/22/2022

Event Type  Injury  

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 stated to be available for return, but has not yet been returned to the manufacturer for evaluation.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature detachment as a potential complication associated with use of the device.

Event Description

It was reported that an embolization coil implant was positioned multiple times after which the physician decided to remove the coil.The coil detached unexpectedly during withdrawal.A syringe and guidewire were used to retrieve the implant.The coil was also observed to be stretched after removed.There was no reported injury to the patient.

Manufacturer Narrative

The investigation of the returned coil system found the implant damaged, severely stretched, and separated from the pusher.The pusher was not returned with the attachment monofilament for evaluation.Without the return and evaluation of the pusher and monofilament, the investigation is unable to determine the mode of separation (i.E.Unintentional vs normal detachment using a detachment controller).Since the investigation could not verify the mode of implant separation due to the absence of the pusher and monofilament, the reported event is considered non-verifiable.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 HELICAL SOFT
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15188033
• MDR Text Key: 297494534
• Report Number: 2032493-2022-00315
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777027726
• UDI-Public: (01)00816777027726(11)210407(17)260331(10)2104075VL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100520HC-R-V-CN
• Device Lot Number: 2104075VL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 62 KG