MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HYPERSOFT HELICALVTA; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100306HS-V-A2
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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.
Event or Problem Description
It was reported that during an embolization treatment, the pusher of an embolization coil implant stretched during positioning.A stent was used to affix the pusher to the vessel wall but the stretched portion extended into the carotid artery.A stent was used to remove the remaining portion of the coil.
Additional Manufacturer Narrative
The pusher was the only component received for evaluation.The investigation of the returned pusher found the distal end broken, damaged and the body coil stretched at transition.Due to the missing implant coil device, the investigation is unable to confirm the stretching of the device as stated in the reported complaint.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.It was reported that the patient woke up a week after the case.Currently, the patient is inarticulate but able to have a meal by himself.It was stated that the patient's condition is unrelated to the reported complaint.

• Brand Name: MICROPLEX HYPERSOFT HELICALVTA
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terry callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13232794
• Report Number: 2032493-2022-00013
• Device Sequence Number: 20010912
• Product Code: HCG
• UDI-Device Identifier: 00816777024114
• UDI-Public: (01)00816777024114(11)200601(17)250531(10)2006015PH
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050954
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 100306HS-V-A2
• Device Lot Number: 2006015PH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2021
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2020
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 65 KG