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

Model Number 182263CS-V-A2

Device Problems Difficult or Delayed Positioning (1157); Malposition of Device (2616); Difficult or Delayed Separation (4044)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

It was reported the physician used this coil as a first coil in a picom aneurysm.The physician placed it and attempted to detach the coil but without result.Physician then decided to retrieve the coil.The pusher detached and physician removed the pusher.Most of coil is inside aneurysm but 10 cm of coil remained in vessel.Physician finished procedure with other coils and without issue for treatment of aneurysm.It is reported the patient is well.

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.Although expected, the reported device has not been received into microvention's complaint system for evaluation.A supplemental and final report will be filed following the completion of the complaint investigation.

Manufacturer Narrative

B5: additional information received notes the patient is well and at home.The coil with 10 cm of the implant in the vessel was secured without the use of a stent.H:10: 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 investigation of the returned coil system found the pusher heater coil damaged, and the implant separated from the pusher.The implant was not returned for evaluation.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.Further investigation of the pusher found epoxy on the proximal gold connector.The unit passed resistance testing but failed continuity testing.Epoxy present on the gold connector in non-polyimide areas can block the sensor in the v-grip, resulting in the implant coil to not have a consistent connection with the detachment controller during the procedure, which is consistent with the non-detachment described in the reported event.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system and tracked by quality.

Event Description

It was reported the physician used this coil as a first coil in a picom aneurysm.The physician placed it and attempted to detach the coil but without result.Physician then decided to retrieve the coil.The pusher detached and physician removed the pusher.Most of coil is inside aneurysm but 10 cm of coil remained in vessel.Physician finished procedure with other coïls and without issue for treatment of aneurysm.It is reported the patient is well.Follow up information received notes the patient is very well and at home.The vessel with 10 cm of coïl is secured without stent.

• Brand Name: MICROPLEX COSMOS 18 VTA
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer (Section G): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15325241
• MDR Text Key: 304875454
• Report Number: 2032493-2022-00334
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777024169
• UDI-Public: (01)00816777024169(11)210908(17)260831(10)0000079247
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K090891
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 182263CS-V-A2
• Device Lot Number: 0000079247
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2021
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Treatment: V-GRIP DETACHER CONTROLLER, UNKNOWN DETAILS
• Patient Age: 67 YR
• Patient Sex: Male