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

Model Number	NV-2-8-HELIX
Medical Device Problem Codes	Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that it was initially reported that the concerto coil could not be released; however it was clarified that this was incorrect and the coil was never inserted into a microcatheter, nor was there any attempt to deploy it.Rather, upon opening the packaging, it was discovered that the pushwire was bent at the end, and therefore the coil was immediately discarded.The device and any accessories were prepared as indicated in the ifu.No patient symptoms or further complications were reported as a result of this event.Additional information received reported that no preparation was performed, as the kink was already identified during unpacking.The procedure was completed using additional concert coils.The cause of the pushwire bent could not be determined.There were no signs of tampering with the packaging.The proximal end was secured with the black clip.There were no issues that resulted in the damage that was found.
Additional Manufacturer Narrative
H3.Product analysis: equipment used: vis m-81805, 203cm ruler m-83361 as found condition (condition of returned device): the concerto device was returned for analysis within a shipping box, inside or a resealable plastic pouch, and alongside an introducer sheath.Visual inspection/damage location details: the introducer sheath was returned damage with blood found within the middle segment of the introducer sheath.The pushwire was found to be bent at ~6.5cm, broken (3 tack welds) at ~8.1cm, bent at ~17.6cm, bent at ~34.6cm, bent at ~122.8cm and bent at ~143.2cm from the proximal end.The concerto implant coil was found to be stretched, damaged (knotted) and broken off of the detach element; in addition, the polypropylene filament was found to be broken off of the detach element.The shield coil was found to be in good condition.The lumen stop and the coin were both noticed to be coated in dried blood.No other anomalies were observed.Testing/analysis (including sem reports): due to the damage condition of the concerto device no further testing was performed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿prod damage/deformed out of pkg¿ was unable to be confirmed.The concerto device was returned damaged (broken) and stretched (knotted).The damage found with the concerto device implies that the device may have been used.Dried blood was found within the introducer sheath and around the pushwire subassemblies is consistent with a lack of a continuous flush during the procedure.No possible root cause was able to be determined.The report notes ¿that it was initially reported that the concerto coil could not be released; however, it was clarified that this was incorrect, and the coil was never inserted into a microcatheter, nor was there any attempt to deploy it¿.This was unable to verify as the returned device looks like it was used within a microcatheter.No microcatheter was returned.The device and any accessories were prepared as indicated in the ifu.Based on the device analysis and reported information, the customer¿s report of ¿pusher kink /damage¿ was able to be confirmed, the concerto pushwire was returned damaged (bends/kinks) in multiple location.A possible cause of ¿pushwire kink/damage¿ is but not limited to user advances coil against resistance; however, the root cause of the ¿pusher kink/damage¿ could not be determined.The report notes that ¿additional information received reported that no preparation was performed, as the kink was already identified during unpacking.¿.This was unable to be confirmed.This event is reported at this time based on analysis findings which indicated a reportable event.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: 23092611
• Report Number: 9617601-2025-01507
• Device Sequence Number: 21284322
• Product Code: KRD
• UDI-Device Identifier: 00847536044883
• UDI-Public: (01)00847536044883(17)270806(10)229439764
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 09/18/2025

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-2-8-HELIX
• Device Catalogue Number: NV-2-8-HELIX
• Device Lot Number: 229439764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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 Sex: Unknown