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

Model Number VFC101540-V-A2

Device Problems Device-Device Incompatibility (2919); Premature Separation (4045)

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

Event Date 01/27/2023

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.The instructions for use identifies premature coil separation as a potential complication associated with use of the device.

Event Description

It was reported that an embolization coil implant encountered resistance during advancement in a microcatheter.The distal loops of the coil exited the catheter when the operator decided to remove the device.The pusher was removed but the coil remained behind, partially deployed and partially within the catheter.There was no patient injury or intervention.

Manufacturer Narrative

The investigation of the returned coil system found the implant returned separated from the pusher with deformed loops.The pusher was not returned for evaluation.The implant's monofilament was found to experience 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 returned microcatheter was found to be kinked at multiple locations along the distal section, which would result in resistance when advancing the coil system through the lumen as described in the reported complaint.The physical evaluation of the devices could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the devices experiencing forces over specification.

Event Description

No new information.

• Brand Name: VFC-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: 16383672
• MDR Text Key: 309643501
• Report Number: 2032493-2023-00573
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022707
• UDI-Public: (01)00816777022707(11)181031(17)230930(10)1810311WV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: VFC101540-V-A2
• Device Lot Number: 1810311WV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2018
• 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