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

Model Number 180308HC-S-V-A2

Device Problem Component Missing (2306)

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

Event Date 09/01/2021

Event Type  malfunction  

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 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
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12595168
• MDR Text Key: 277753523
• Report Number: 2032493-2021-00400
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022097
• UDI-Public: (01)00816777022097(11)210329(17)260228(10)2103295PE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050954
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2021
• 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