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

Model Number	PV-20-50-HELIX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis as it was implanted in the patient.The device system was reported to have been discarded at the site.Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.Based on the received information, it appears that user error may have contributor to the reported event as the device was not used per the instructions for use.Per the instructions for use (ifu): preparations for use 1.In order to achieve optimal performance of the concerto¿ detachable coil and to reduce the risk of thromboembolic complication, it is advised that a continuous saline flush be maintained between a.The femoral sheath and the guiding catheter, b.The micro catheter and guiding catheter and c.The micro catheter and the implant delivery pusher and the concerto¿ detachable coil.2.Place the appropriate guiding catheter following recommended procedures.Connect a rotating haemostatic valve (rhv) to the hub of the guiding catheter.Attach a 3-way stopcock to the side arm of the rhv, then connect a line for the continuous flush.3.Attach a second rhv to the hub of the micro catheter.Attach a 1- way stopcock to the side arm of the rhv, then connect a line for continuous flush.For concerto¿ detachable coils: one drop from the pressure bag every 3-5 seconds is suggested for pgla or nylon fiber concerto¿ detachable coils: one drop from the pressure bag every 1-3 seconds is suggested.4.Check all fittings so that air is not introduced into guiding catheter or micro catheter during continuous flush.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the concerto coil prolapsed within the catheter.Force was applied and the coil unintentionally separated from the pushwire.However, the coil was implanted within the intended location.Resistance was felt during the advancement.A continuous flush was not used.The pushwire was not damaged.The device was repositioned three times.The device was attempted to be detached 2 times with an instant detacher.Manual detacher was not attempted.The pushwire was rotated during the delivery.The devices were prepared the instructions for use (ifu).

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8969100
• Report Number: 2029214-2019-00902
• Device Sequence Number: 14094007
• Product Code: KRD
• UDI-Device Identifier: 00847536017146
• UDI-Public: 00847536017146
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/05/2021
• Device Model Number: PV-20-50-HELIX
• Device Lot Number: A625551
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2019
• Initial Report FDA Received Date: 09/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1