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

Model Number VFC030615-V-A

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  Injury  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The device was returned to the manufacturer for evaluation.The investigation is currently ongoing.

Event Description

It was reported that during placement of a coil in a giant aneurysm on the right internal carotid artery, one loop prolapsed into the parent vessel.Several coils had just been previously placed in the aneurysm.An attempt was made to reposition the coil and during retraction, the coil stretched.The coil was successfully removed in its entirety with a gooseneck snare without further incident.There was no reported patient injury and the patient was reported to be doing well.

• Brand Name: MICROPLEX VFC FILL COIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: eva manus ; 1311 valencia avenue; tustin, CA 92780 ; 7142478000
• MDR Report Key: 6049516
• MDR Text Key: 58128490
• Report Number: 2032493-2016-00259
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00811425026335
• UDI-Public: (01)00811425026335(11)160512(17)210512(10)160512V3
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/12/2021
• Device Model Number: VFC030615-V-A
• Device Lot Number: 160512V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/12/2016
• 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: 65 YR