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 Codes	Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis as found condition: the concerto coil was returned for analysis within a shipping box; within an opened concerto outer carton; within a sealed plastic biohazard pouch and within a piece of lint-free wipe.The unknown non-medtronic micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the concerto implant coil was found damaged.The implant coil was found already detached from the pusher.The pusher was not returned for analysis.The detach element stick was found broken.Testing/analysis: the concerto coil could not be used for resistance testing due to the damaged condition and due to the implant already detached.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed as the damages found is consistent with resistance.Customer reported the cause of the resistance was due to mishandling and the ifu instructions were not followed.The returned concerto implant coil was found damaged and the detach element stick was found broken.It is likely these damages occurred due to advancing against the reported resistance.As the unknown micro catheter used during the event was not returned for analysis, any contributing factors of the micro catheter towards the resistance could not be determined.As the model and lot numbers were not reported, compatibility could not be assessed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that two coils were trapped in the multipurpose delivery catheter possibly due to mishandling.The proce dure was completed with inputs from the company and competing products.The ifu (instruction for use) was not followed during preparation, procedure, post-procedure as no rebar microcatheter was used.No patient symptoms or complications were associated with this event.There was no medical or surgical intervention, the event did not lead to or extend hospitalization, and there was no injury.The lesion/vessel site associated with the event was the left distal gonadal vein.It was noted the patient's vessel tortuosity was moderate.There was no calcification.The vessel was not pre or post-dilated.It was noted that there were abnormalities in relation to anatomy including pelvic varicose veins.Additional information received that the cause of the resistance was the physician did not adequately address the coil with the hypotube.The resistance was located in the distal section.The coils came out of the introducer sheaths smoothly.There was a kink/damage to the coils observed after removal.The catheter was not a medtronic product.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 20687627
• Report Number: 2029214-2024-02121
• Device Sequence Number: 15585635
• Product Code: KRD
• UDI-Device Identifier: 00847536045064
• UDI-Public: 00847536045064
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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 Model Number: PV-20-50-HELIX
• Device Catalogue Number: PV-20-50-HELIX
• Device Lot Number: B712133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG