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

Model Number VFC030610-V-A

Device Problems Detachment Of Device Component (1104); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2017

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not yet been returned for evaluation.The investigation is currently underway.The device was used during the same procedure as was reported in mfr.Report# 2032493-2017-00116.

Event Description

It was reported that while repositioning an embolization coil in a ruptured aneurysm, the coil stretched and then detached in the microcatheter.Both segments of the coil were removed together with the microcatheter from the patient.There was no reported patient injury.The patient's current status is reported to be good.

Manufacturer Narrative

The device was received with the implant detached from the pusher.Pusher remained in the introducer sheath.The implant was stretched from the tie knot section throughout out the length of the implant.The sr member was observed to be broken.Knotted monofilament remained present at the proximal knot section.The pusher heater coil was collapsed within the distal black pet.The pusher body coils were wavy, and the ss wire was broken and protruding from the body coils distal of the transition black pet.Based on the provided information the complaint of stretched implant was confirmed; however, the reported break could not be confirmed.The specific root cause of this complaint is unknown, although the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

• Brand Name: MICROPLEX VFC FILL COIL
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• Manufacturer Contact: debby callahan ; 1311 valencia avenue; tustin, CA 92780
• MDR Report Key: 6571489
• MDR Text Key: 75325447
• Report Number: 2032493-2017-00117
• Device Sequence Number: 1
• Product Code: HGC
• UDI-Device Identifier: 00811425026328
• UDI-Public: (01)00811425026328(11)151202(17)201202(10)151202VC2
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2017

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
• Device Operator: Physician
• Device Expiration Date: 12/02/2020
• Device Model Number: VFC030610-V-A
• Device Lot Number: 151202VC2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/17/2017
• Initial Date FDA Received: 05/16/2017
• Supplement Dates Manufacturer Received: 04/17/2017
• Supplement Dates FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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