MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX VFC ADVANCED; NEUROVASCULAR EMBOLIZATION COIL

Model Number	VFC030606-V-A1-CN
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional 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 currently ongoing.A supplemental report will be submitted with the findings and conclusions.The instructions for use identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of an aneurysm, an embolization coil implant could not be advanced or retracted.The implant was noticed to have been detached from the pusher and was removed along with the microcatheter.The procedure was successfully completed with a different coil.There was no intervention or injury.The patient was reported to be "fine.".
Additional Manufacturer Narrative
Items returned for evaluation: -pusher -implant -introducer -dispenser hoop.Items not returned for evaluation: -shrink lock -microcatheter -v-grip.The visual analysis of the returned items found that the implant was severely stretched and broken, but still attached to the pusher.The distal portion of the implant and the microcatheter were not returned for evaluation.The investigation of the returned coil system found the implant coils severely stretched and broken.The portion of the implant distal to the site of the break was not returned for evaluation; however, the investigation found the most proximal end of the implant to still be attached to the pusher.The complaint is considered confirmed due to the proximal side of the implant separating from its distal portion.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 retraction forces over specification.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.
Event or Problem Description
It was reported that during treatment of an aneurysm, an embolization coil implant could not be advanced or retracted.The implant was noticed to have been detached from the pusher and was removed along with the microcatheter.The procedure was successfully completed with a different coil.There was no intervention or injury.The patient was reported to be "fine.".

• Brand Name: MICROPLEX VFC ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION COIL
• 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: 17183220
• Report Number: 2032493-2023-00809
• Device Sequence Number: 20469758
• Product Code: HCG
• UDI-Device Identifier: 00812636026237
• UDI-Public: (01)00812636026237(11)211119(17)261031(10)0000126501
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132317
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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
• Operator of Device: Health Professional
• Device Model Number: VFC030606-V-A1-CN
• Device Catalogue Number: VFC061030-V
• Device Lot Number: 0000126501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2023
• Supplement Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 55 KG