MAUDE Adverse Event Report: MICROVENTION, INC. COSMOS-18-AV; COILS

Model Number 8218-1036-A1-CN

Device Problem Premature Separation (4045)

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

Event Date 01/05/2024

Event Type  malfunction  

Event Description

It was reported during a coil embolization procedure.Resistance was encountered while advancing the coil into the microcatheter and could not be delivered.It was found that the coil unintentionally detached and stretched.The coil and microcatheter were removed from the patient and procedure completed using another coil.There was no patient injury and reported to be in good condition.

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 stated to be available for return to the manufacturer for evaluation but has not yet been returned.The alleged premature separation as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.

Manufacturer Narrative

Investigation conclusion: the investigation of the returned coil system found the implant stretched at the proximal section and separated from the pusher.The pusher was not returned for evaluation.The investigation found the implant'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.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 microcatheter used in the procedure returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

Event Description

No additional information was received, please see h6 and h10.

• Brand Name: COSMOS-18-AV
• Type of Device: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18611345
• MDR Text Key: 334783088
• Report Number: 2032493-2024-00094
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00842429105580
• UDI-Public: (01)00842429105580(11)230914(17)280831(10)0000425370
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8218-1036-A1-CN
• Device Lot Number: 0000425370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/30/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2023
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 54 KG