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

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

  • 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
 

MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO PGLA HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION Back to Search Results
Model Number PV-18-40-HELIX
Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/05/2021
Event Type  malfunction  
Event Description
Medtronic received a report that there was resistance felt during delivery and the coil was broken.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the subcarinal vascular location with an unknown max diameter and a 3mm neck diameter.It was noted the patient's blood flow was high and vessel tortuosity was severe.It was reported that the doctors found a piece of broken coil wire when they removed the introducer sheath from the femoral artery after completing the procedure.So they arranged the patient to do another ct scan and they found that the coil wire/filament was broken and retained in the patient.It was decided to cut down the groin and attempt to use a snare and remove the coil filament.After a few attempts, part of the coil filament was removed and broken into three pieces.There was a short segment of the coil filament that could not be removed and remained in the patient's body.The patient's condition was fine and there was no further treatment needed at the moment.It was thought that the coil filament was maybe due to a premature detachment of the coil during delivery.There was strong resistance felt during delivery and the coil prematurely deployed when the doctors attempted to remove the coil wire form the catheter.The coil was implanted in its intended location.The pushwire was bent/broken and not on purpose.The physician repositioned the coil 2-3 times.The physician did not attempt to detach the coil and the physician did not rotate the delivery pusher during the procedure.A continuous flush was administered during the procedure.The devices were prepared as indicated in the ifu.There were no patient symptoms or complications associated with this event.Ancillary devices include: merit model#7521-13 guide catheter and merit models28mc24130sn microcatheter.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
H3: the concerto coil was found stretched and broken with the polypropylene filament also broken.The implant coil tip and detach el ement were not returned for analysis.The concerto pusher was also not returned for analysis.Based on the event description and analysis performed, the customer report of ¿premature detachment", ¿pusher kink/damage¿ and ¿coil resistance/stuck in catheter¿ could not be confirmed as the pusher was not returned.The customer report of ¿coil separation/break¿ was confirmed.Possible causes are tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, and user advances the coil against resistance.Customer reported the vessel tortuosity as severe devices were repositioned 2-3 times, no detachments were attempted, and devices were prepared per ifu.As the pusher and the merit 28mc24130sn micro catheter used in the event was not returned for analysis, any contribution of the pusher and the micro catheter towards the failure could not be determined.The 28mc24130sn micro catheter has a rated inner diameter of 0.020¿ (per merit website) is compatible for use with the concerto coil.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CONCERTO PGLA HLX
Type of Device
DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key12915882
MDR Text Key289102781
Report Number2029214-2021-01552
Device Sequence Number1
Product Code KRD
UDI-Device Identifier00847536033672
UDI-Public00847536033672
Combination Product (y/n)N
Reporter Country CodeHK
PMA/PMN Number
K090046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPV-18-40-HELIX
Device Catalogue NumberPV-18-40-HELIX
Device Lot NumberB231657
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age65 YR
Patient SexMale
-
-