MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CONCERTO NYLON; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	NV-7-30-HELIX
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information regarding a concerto coil non-detachment.It was reported that the concerto coil and all accessory devices were prepared as indicated in the instructions for use (ifu).An instant detacher was not used.The coil would not detach despite three attempts to detach manually with the hypotube.The coil was withdrawn and replaced to complete the procedure successfully.There was no harm or injury to the patient.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
B5.Updated with additional information received.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 there were no issues encountered prior to the coil non-detachment.The coil was not initially damaged; the only damage present was due to damage inflicted by the physician due to the three attempts to manually detach the coil.
Additional Manufacturer Narrative
H3.Product analysis: equipment used- vis m-81805, 203cm ruler m-83360 as found condition- the concerto device was returned for analysis within a shipping box, within an opened concerto implant coil inner pouch (lot- 230990123), with a dispenser coil, and alongside an introducer sheath.No microcatheter was returned.Visual inspection/damage location details ¿ the introducer sheath was returned and found to be in good condition.During inspection, the actuator interface, positive load indicator, break indicator and a piece of the release wire were all found to be broken off and not returned.This is possible evidence of a manual detachment attempt, which would confirm the customers report of ¿the coil would not detach despite three attempts to detach manually with the hypotube.¿.The pushwire was found to be bent at ~5.2cm, bent at ~18.6cm, and bent at ~31.2cm from the broken proximal end.The concerto implant coil was found to be attached and intact with the pushwire detach element.The coin was found against the lumen stop; however, occluded with solidified blood.No damage was found with the shield coil.The concerto implant coil returned unsheathed and damaged.No other anomalies were observed.Testing/analysis ¿ during testing, a manual detachment attempt failed, as the coin did not retract from the lumen stop.The pushwire was soaked in alcohol to help dissolve the solidified blood found occluding the coin and lumen stop.While trying to retract the coin the from lumen stop.Both the coin and detach element were damaged.The stick and ball (damaged) was measured to be 0.032¿ which was found to be within specification.The lumen stop was found to be damaged and occluded with solidified blood.The damage possibly occurred from the coin jamming up against the lumen stop during the reported failed detachment attempts.No accurate measured of the lumen stop was able to be recorded due to the damage.The retainer ring was also found to be occluded with blood and unable to be accurately measured.No further testing was able to be performed.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" was able to be confirmed, as the concerto implant coil was returned still attached and intact with the pushwire detach element.During testing, a manual detachment attempt failed.The pushwire was broken at the proximal end and the implant coil did not detach.The coin and lumen stop were both found to be occluded with solidified blood, which could be the likely cause for the non-detachment.The detach element and subassemblies possibly malfunction from occlusion (blood under shrink tubing at detachment zone).A few other possible causes of ¿non-detachment¿ are but not limited to, damaged pusher and/or coin jammed at lumen stop; however, the root cause was unable to be determined.No catheter was mentioned in the report; therefore, any contribution the unknown catheter had towards the non-detachment/damage was unable to be assessed.Compatibility was unable to be confirmed.No mention of a continuous flushing being administered during the procedure was reported.No mention of the patients vessel tortuosity was noted.It was reported that the concerto coil and all accessory devices were prepared as indicated in the instructions for use (ifu).H6.Coding updated based on analysis findings.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 S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 24402992
• Report Number: 9617601-2026-01348
• Device Sequence Number: 9905554
• Product Code: KRD
• UDI-Device Identifier: 00847536044968
• UDI-Public: (01)00847536044968(17)280402(10)230990123
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 05/04/2026

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-7-30-HELIX
• Device Catalogue Number: NV-7-30-HELIX
• Device Lot Number: 230990123
• 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: 02/17/2026
• Supplement Date Received by Manufacturer: 02/20/2026; 04/08/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 03/20/2026; 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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: Unknown