MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COSMOS 18 VTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 181652CS-V-A2

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

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

Event Date 08/23/2021

Event Type  malfunction  

Manufacturer Narrative

A search for non-conformance's 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 investigation of the returned coil system found the implant to be intact and still attached to the pusher.The pusher was received stretched and broken at the proximal side.The other half of the pusher was not returned back for evaluation.Due to the condition of the returned device, replication testing could not be performed to determine the cause of the reported complaint.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.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 advancement within a microcatheter, an embolization coil implant encountered resisteance.Upon removal, the implant detached from the delivery pusher.There was no reported patient injury or intervention.The patient's condition is reported to be "good.".

• Brand Name: MICROPLEX COSMOS 18 VTA
• Type of Device: NEUROVASCULAR 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: 12522793
• MDR Text Key: 273433805
• Report Number: 2032493-2021-00389
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777024138
• UDI-Public: (01)00816777024138(11)191021(17)240930(10)1910211W1
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K090891
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 181652CS-V-A2
• Device Lot Number: 1910211W1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2019
• 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