• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROVENTION, INC. MICROPLEX VFC FILL COIL EMBOLIZATION COIL Back to Search Results
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 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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMICROPLEX VFC FILL COIL
Type of DeviceEMBOLIZATION COIL
Manufacturer (Section D)
MICROVENTION, INC.
1311 valencia avenue
tustin CA 92780
Manufacturer Contact
debby callahan
1311 valencia avenue
tustin, CA 92780
MDR Report Key6571489
MDR Text Key201839696
Report Number2032493-2017-00117
Device Sequence Number1
Product Code HGC
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K111451
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/17/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/16/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/02/2020
Device Model NumberVFC030610-V-A
Device Lot Number151202VC2
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/02/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-