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

Model Number 181231CC-V-CN

Device Problems Detachment of Device or Device Component (2907); Activation Failure (3270)

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

Event Date 09/06/2021

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 was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.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 an embolization treatment, the coil unintentionally detached.The physician used a snare to remove the coil from the patient.The case was completed successfully.There was no reported patient injury or intervention.

Event Description

Additional clarification received indicating the coil did not detach and was removed, then the physician used and placed a solitaire ab stent to complete the case.

Manufacturer Narrative

Additional clarification received indicating the coil did not detach and was removed, then the physician used and placed a solitaire ab stent to complete the case.Accordingly, this event is no longer assessed reportable by microvention, inc.

• Brand Name: MICROPLEX COMPLEX
• Type of Device: EMBOLIZATION COIL
• 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: 12973272
• MDR Text Key: 282034091
• Report Number: 2032493-2021-00478
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777028198
• UDI-Public: (01)00816777028198(11)200529(17)250430(10)2005295V3
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 181231CC-V-CN
• Device Lot Number: 2005295V3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2020
• 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: 49 YR
• Patient Sex: Male