MAUDE Adverse Event Report: MEDTRONIC MEXICO CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-3-4-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	08/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of nv-3-4-helix, lot no:226052134 found the concerto implant coil returned without introducer sheath.The actuator interface was intact.The concerto coil pushwire was bent at ~ 16.3cm, kinked at ~25.8cm, and bent at ~45.2cm from proximal end.The implant coil was broken and returned.The shield coil was intact.The implant coil was stretched and damaged.All other subassemblies appeared to be normal, and no other anomalies were observed.The concerto coil could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Based on the device analysis and the reported information, the customers report of ¿catheter resistance¿ could not be confirmed and the root cause could not be determined.Possible causes for coil resistance in catheter are, but not limited to, use of an incompatible device for delivery, and failure to hydrate the concerto coil prior to use.The model or lot number for the unknown catheter were not provided; therefore, compatibility could not be assessed.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.
Event or Problem Description
Medtronic received a report that when repositioning the coil, it cannot be pushed.The coil was kinked/damaged.There was friction during testing or delivery.Continuous flush was administered during the procedure.The damage was located on the pushwire proximal segment.The physician repositioned the coil during the procedure 2 times.No patient symptoms or further complications were reported as a result of this event.The device and any accessories were prepared as indicated in the ifu.The patient was undergoing surgery for endoleak treatment.It was noted the patient's blood flow was high and vessel tortuosity was normal.Ancillary devices include a renegade microcatheter.Additional information was received that catheter resistance occurred in the proximal section.The coil came out of the introducer sheath smoothly.

• Brand Name: CONCERTO NYLON
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18693880
• Report Number: 9612164-2024-00746
• Device Sequence Number: 12530500
• Product Code: KRD
• UDI-Device Identifier: 00847536044890
• UDI-Public: 00847536044890
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

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 Expiration Date: 02/22/2026
• Device Model Number: NV-3-4-HELIX
• Device Catalogue Number: NV-3-4-HELIX
• Device Lot Number: 226052134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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 Sex: Male