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

Model Number VFC010303-V

Device Problems Stretched (1601); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2019

Event Type  Injury  

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 implant and delivery pusher were returned for analysis.The implant was still attached to the delivery pusher.The delivery pusher was received broken without the hypotube attached to the body coil.The pusher body coil was returned stretched, and the attachment glue bond was stretched as well.The implant had no form or shape, and was stretched at the proximal tie knot section.The investigation is unable to determine the cause of the damage on the device but is consistent with a device that was experiencing forces over specification during removal from the catheter.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that an embolization coil became stuck in the microcatheter.When an attempt was made to retract the device, the coil stretched and then broke.A snare was used to retrieve the broken coil.No patient injury was reported.The patient is reported to be "fine.".

• Brand Name: MICROPLEX VFC ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 9330359
• MDR Text Key: 166959072
• Report Number: 2032493-2019-00267
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022639
• UDI-Public: (01)00816777022639(11)190612(17)240531(10)1906125WV
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K132317
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VFC010303-V
• Device Lot Number: 1906125WV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2019
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Weight: 75