MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL SOFT VTA; ARTIFICIAL EMBOLIZATION DEVICE

Model Number	180308HC-S-V-A2
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2021
Type of Reportable Event	Malfunction
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 pusher and introducer were the only components returned for analysis.The investigation of the returned pusher found the implant to be separated from the pusher at the attachment bond section.The attachment monofilament profiles a tensile break at the attachment bond 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 or when this occurred, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
It was reported that an embolization coil implant was missing from the delivery pusher.There was no patient injury or intervention.The patient's condition is reported to be "good.".

• Brand Name: MICROPLEX HELICAL SOFT VTA
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12595168
• Report Number: 2032493-2021-00400
• Device Sequence Number: 4306188
• Product Code: HCG
• UDI-Device Identifier: 00816777022097
• UDI-Public: (01)00816777022097(11)210329(17)260228(10)2103295PE
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/07/2021

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 Expiration Date: 02/28/2026
• Device Model Number: 180308HC-S-V-A2
• Device Lot Number: 2103295PE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1