MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 100412CSSR-V-A1-CN

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

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

Event Date 07/07/2022

Event Type  malfunction  

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 returned to the manufacturer for evaluation.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.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 the withdrawal of an embolization implant coil, the implant stretched and unintentionally detached in the microcatheter.There was no reported injury to the patient or intervention.

Manufacturer Narrative

Summary device evaluation: the investigation of the returned coil system found the pusher stretched and broken at the transition area.The implant was not attached to the pusher and the heater coil showed no signs of activation using a detachment controller.The implant was found to be stuck in the microcatheter distal end and upon retrieval, the implant coils were found damaged with deformed loops at the proximal section.Further investigation found the monofilament experienced a tensile break based on the profile of 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.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: COSMOS-10-AV
• 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: 15446835
• MDR Text Key: 306267033
• Report Number: 2032493-2022-00371
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00812636025506
• UDI-Public: (01)00812636025506(11)220203(17)270131(10)0000154435
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K082461
• 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: 09/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 100412CSSR-V-A1-CN
• Device Lot Number: 0000154435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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 Age: 50 YR
• Patient Sex: Female
• Patient Weight: 48 KG