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

Model Number	PV-20-50-HELIX
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that two concerto coils got stuck in the catheter in the proximal and distal section.The patient was undergoing surgery for a hypo takedown staged for aaa procedure.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that multiple concerto coils tracked successfully (pv 16x4- 3d(2), pv 20x50(3), pv-14x30-helix(2)).The last 2 pv-20-5-helix did not track and decided to switch from progreat 2.8 to boston scientific renegade and they still did not track.Representative offered up terumo coil and successfully tracked.Case was finished with amplaster plug.Trouble shooting included re-flushing the  microcatheter many times, and re-flushing coils in water per ifu.The microcatheter was also straightened out to ensure direct path for the coil.Resistance occurred in the proximal and distal sections.The implant coils pushed smoothly out from the introducer sheath.The catheter and coils were not damaged.The reported devices and any accessory devices were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a terumo progreat 2.8 microcatheter and a boston scientific 2.8 renegade microcatheter.
Additional Manufacturer Narrative
Product analysis #(b)(4): equipment used: vis m-85519; ruler 203cm m-83361 as found condition: the concerto coil returned within shipping box; within a sealed biohazard pouch; within another a sealed biohazard pouch; within an opened concerto coil inner pouch and within a resealable biohazard pouch.Damage location details: the concerto coil was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pusher with the wave-lock at the proximal end.The pusher was found to be broken at ~ 7.9cm from the proximal end with the release wire intact.No damages were found with the introducer sheath.What appeared to be blood was found within the introducer sheath.No damages were found with the implant coil.No other anomalies were observed.Testing analysis: the concerto coil could not be used for resistance testing with an in-house catheter due to its damaged condition.Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed.The pusher was returned broken.The concerto coil can become damaged if advanced against resistance.It is possible that these damages occurred when the customer attempted to advance the coil through the catheter against the resistance.Possible causes of resistance include the use of a damaged catheter, incompatible catheter, lack of hydration before the procedure, patient tortuous anatomy and lack of continuous flush with heparinized saline during delivery.The device was prepared according to the instructions for use (ifu).A continuous flush was administered.The patient¿s vessel tortuosity was normal.The progreat 2.8 and boston scientific 2.8 renegade microcatheters used for the event were not returned.Therefore, the condition of the progreat 2.8 and boston scientific 2.8 renegade microcatheters could not be assessed.Per an online source, the progreat 2.8 and boston scientific 2.8 renegade microcatheters have an id (inner diameter) of 0.027¿.As per the ifu, the concerto coil is compatible for use with microcatheters with a minimum id (inner diameter) of 0.0165¿.Therefore, the progreat 2.8 and boston scientific 2.8 renegade microcatheters were found to be compatible with the concerto coil.The root cause could not be determined.(gamboj3 2023-03-03).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.

• Brand Name: CONCERTO PGLA HLX
• Common Device Name: 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 Key: 16497103
• Report Number: 2029214-2023-00420
• Device Sequence Number: 6316012
• Product Code: KRD
• UDI-Device Identifier: 00847536045064
• UDI-Public: 00847536045064
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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: 09/04/2025
• Device Model Number: PV-20-50-HELIX
• Device Catalogue Number: PV-20-50-HELIX
• Device Lot Number: B469630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Male