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

Model Number	NV-2-4-HELIX
Medical Device Problem Codes	Stretched (1601); Separation Failure (2547); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the concerto coil would not detach.The patient was undergoing surgery for treatment of a hemorrhage.It was noted the patient's blood flow was high and vessel tortuosity was severe.It was reported that the physician has successfully delivered the nv-2-4-helix via the merit maestro 2.4f microcatheter.However, when the physician tried to deploy the coil with instant detacher, the coil is failed to deploy.Then the coil was found stretched and elongated.The physician has successfully retrieved the coil.The physician has completed the procedure by using cook nester pushable coils.The reported device and any accessory devices were not prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.Ancillary devices include a merit maestro 2.4 f microcatheter.
Additional Manufacturer Narrative
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported that there were no issues that resulted in the damage that was found.A few attempts were made to detach the coil using the instant detacher (lot# b649297).No attempts were made to detach the coil using the manual method.Prior to coil non-detachment resistance was found when pushing the coil out of the microcatheter.No pushwire damage observed after removal from the patient.
Additional Manufacturer Narrative
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
The resistance was in the middle section of the catheter.The coil did come out of the introducer sheath smoothly.
Additional Manufacturer Narrative
H3: product analysis of nv-2-4-helix, item:10,lotno:228091511 as found condition: the concerto implant coil was returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within a piece of surgical wrap.The pusher was not returned for analysis.The merit maestro 2.4f micro catheter used during the event was not returned for analysis.Visual inspection/damage location details: the implant coil was found severely damaged and stretched with the polypropylene filament broken.The detach element was separated from the implant and not returned for analysis.The pusher was not returned for analysis.Testing/analysis: the device could not be testing for resistance or detachment due to the damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed as the damage found is consistent with resistance.Possible causes for coil resistance in catheter are, but not limited to, lack of hydration before procedure, user does not maintain continuous flush, damage to the micro catheter or tortuous anatomy.Customer reported patient vessel tortuosity as severe, and devices were prepared per ifu.It is possible the severe vessel tortuosity contributed towards the resistance.The customer report of ¿coil stretch¿ was confirmed, which could have also been caused by the severe tortuosity.The customer report of ¿non-detachment¿ could not be determined as the implant was returned severely damaged and already separated from the pusher.As the pusher, instant detacher, and detach element were not returned, any contribution of the pusher, instant detacher and detach element towards the non-detachment could not be determined.As the merit maestro 2.4f micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the reported failures could not be assessed.The merit maestro has a minimum id of 0.018¿ (per merit website) and is therefore compatible for use with the concerto coil 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19250408
• Report Number: 9612164-2024-02140
• Device Sequence Number: 6437975
• Product Code: KRD
• UDI-Device Identifier: 00847536044869
• UDI-Public: 00847536044869
• 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,Followup,Followup,Followup
• Report Date (Section B): 07/26/2024

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: NV-2-4-HELIX
• Device Catalogue Number: NV-2-4-HELIX
• Device Lot Number: 228091511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2024
• Supplement Date Received by Manufacturer: 05/07/2024; 06/06/2024; 07/03/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 05/22/2024; 07/02/2024; 07/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• 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: 85 YR
• Patient Sex: Female