MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 CONCERTO VERSA, DETACHABLE COIL; DEVICE, EMBOLIZATION, VASCULAR

Model Number	CV-20-65
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a concerto versa coil that had resistance during delivery and detached prematurely.The patient was undergoing a procedure for hypogastric internal iliac embolization prior to endovascular aneurysm repair (evar).Vessel tortuosity was minimal.It was reported that the devices were not inspected or prepared as indicated in the instructions for use.The surgeon was very experienced in concerto coiling procedures and opted instead to not inspect and hydrate the coils first and not use a continuous flush.Instead, the catheter was flushed with a syringe prior to the versa coil being inserted and between each coil. the first coil used was a versa cv-20x65 lot b156255.The hypo was aneurysmal distally with acute and subacute thrombus.The physician used a non-tapered 4 fr glide catheter 100cm length.The coil was not hydrated or inspected prior to use but was kept straight during insertion except for one large loop.The physician loaded the versa into the catheter until approximately 9 inches remained from the end of the coil to the hub.At this point the physician went to remove the versa introducer sheath and went to advance the pushwire.The pushwire felt different to the physician.Upon inspection/follow up, the physician was trying to advance by pushing on the distal portion (c losest to detachment zone) of the pusher wire (delivery pusher) that is more delicate and tapered.The physician tried to advance the coil and felt resistance.After pushing and pulling slightly, the physician elected to remove the versa and move forward using standard concerto.018 coils.Upon removal, versa was determined to be prematurely detached inside the catheter.The physician then decided to use a stiff wire to advance the coil though the catheter.There was some resistance and the physician had to use two wires to advance the coil, but the coil was ultimately implanted successfully at the intended location.At that point, a non-medtronic microcatheter was placed and 6 more coils were placed without issue.Upon successfully hypogastric embolization, the physician moved forward with the evar and successfully completed that portion of the procedure.There was no harm or injury to the patient.

• Brand Name: CONCERTO VERSA, DETACHABLE COIL
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 11592811
• Report Number: 2029214-2021-00370
• Device Sequence Number: 4497119
• Product Code: KRD
• UDI-Device Identifier: 00763000321925
• UDI-Public: 00763000321925
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K202850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: 02/04/2024
• Device Model Number: CV-20-65
• Device Catalogue Number: CV-20-65
• Device Lot Number: B156255
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 81 YR