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

Model Number 100206HS-V-N

Device Problems Stretched (1601); Separation Failure (2547); Detachment of Device or Device Component (2907)

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

Event Date 02/14/2022

Event Type  Injury  

Event Description

It was reported that an embolization coil implant would not detach completely from the delivery pusher.After the detachment attempt, the delivery pusher appeared attached to the implant.During removal, the implant detached.Intervention was taken to remove the coil in the form of a "loop maneuver." there was no reported injury to the patient.This device was used during the same procedure as mfr report # 2032493-2022-00095.

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 implant was the only component received for evaluation.The investigation of the returned coil system found the implant severely stretched, damaged, and tangled with the related implant (2032493 -2022-00095).The coil pusher was not returned.No residue from the pusher was found on the returned implant.Without the return and evaluation of the pusher, 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, the reported event is considered non-verifiable.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as a potential complication associated with use of the device.

• Brand Name: MICROPLEX HYPERSOFT HELICAL
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13810966
• MDR Text Key: 287426439
• Report Number: 2032493-2022-00096
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00810170019463
• UDI-Public: (01)00810170019463(11)201111(17)251031(10)2011115NH
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/17/2022

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: Health Professional
• Device Model Number: 100206HS-V-N
• Device Catalogue Number: 100204HFIL-V
• Device Lot Number: 2011115NH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention