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

Model Number VFC030615-V

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 10/27/2019

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.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 has not been returned to the manufacturer.The root cause of the complaint cannot be determined.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 during treatment of an acute basilaris sidewall aneurysm, the coil was positioned in the aneurysm and was observed to not fit desirably as it was going into the artery.It was decided to withdrawal the coil.Approximately 90% was removed and the coil detached.Attempts were made to remove the coil using a solitaire stent unsuccessfully.Two atlas stents were used to fix the coil on the vessel wall successfully.Following the procedure, the patient was reported to have had a stroke.It was reported that it was unclear if the stroke was from the treatment or the previous bleeding.The patient is recovering.

• 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: 9377563
• MDR Text Key: 168058075
• Report Number: 2032493-2019-00273
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777022660
• UDI-Public: (01)00816777022660(11)190722(17)240630(10)1907225WV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K111451
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: VFC030615-V
• Device Lot Number: 1907225WV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2019
• 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; Disability
• Patient Age: 29 YR