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

Model Number	NV-3-8-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	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3.Product analysis:equipment used: vis m-81805, 203cm ruler- 83361 pin gauges m-84080 m-84083 as found condition (condition of returned device): the concerto device was returned for analysis within a shipping box, a sealed plastic biohazard pouch, within a resalable plastic pouch, and within an introducer sheath.No microcatheter was returned.Damage location details: the introducer sheath was found to be applied correctly; however, the introducer sheath was found to be damaged (crushed) near the distal segment.The actuator was found to be bent at ~3.3cm, broken at ~6.2cm, broken at ~8.8cm, bent at ~24.7cm and bent at ~69.3cm from the proximal end.The release wire was found to be retracted, and the implant coil was detached within the introducer sheath.The concerto implant coil was found to be damaged within the introducer sheath.The shield coil was found to be in good condition.The coin was found to be retracted from the lumen stop, but in good condition.No other anomalies were observed.Testing/analysis (including sem reports): during testing, the concerto implant coil was unable to advance outside of the introducer sheath.The concerto implant coil tip outer diameter (od) was measured to be 0.0114¿, which was found to be within specification (specification.0112¿ +.0010¿/-.002¿).The introducer sheath id (inner diameter) was measured to be.0185¿ (0.47mm), which was found to be within specification (specification 0.47mm +0.03mm/-0.00mm).Conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was able to be confirmed.Resistance was able to be reproduced with the introducer sheath.A possible cause of ¿coil resistance/stuck in sheath¿ could have been caused during preparation.Via the ifu, notes that ¿gently immerse the concerto detachable coil and its detachment zone in heparinized saline.Take care not to stretch the coil during this procedure, in order to preserve the coil memory.While still immersed in the heparinized saline, point introducer sheath vertically into saline and gently retract the distal tip of the coil into the introducer sheath.¿ the report notes that ¿the staff did not believe that the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.¿; however, the root cause of ¿coil resistance/ stuck in sheath¿ was unable to be determined.A few other possible causes of ¿coil resistance/stuck in sheath¿¿ are but not limited to overtightening of rhv, improper hubbing technique, and lack of continuous flush.Preparation per the ifu was mentioned in the report; however, it wasn¿t verified.Damaged was found to the introducer sheath near the distal segment.A possible cause for the damage to the introducer sheath could of be caused by excessive tightening of rhv.The root cause could not be confirmed.The customer¿s report of ¿coil kink/damage¿ was able to be confirmed.The concerto device was returned damaged (broken and kinked).A possible cause of ¿coil kink/damage could have been cause by advancing device against the reported resistance; however, the root cause was unable to be determined.**this event is reported at this time 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.
Event or Problem Description
It was reported that during a procedure involving the coil concerto helix 3mm x 8cm and coil concerto helix 5mm x 20cm, the coils would not pass through the coil delivery sheath.This issue occurred with both products, identified as nv-3-8-helix and nv-5-20-helix.The staff noted coil resistance/stuck and instances of coil kink or damage.Despite these issues, other concerto coils were used successfully in the case.The defective products were not implanted and were replaced by medtronic products. no patient complications have been reported as a result of this event.Ancillary devices: sheath, microcatheter, guidewire additional information received reported continuous saline flush was not administered and maintained as indicated in the instructions for use (ifu).Ifu prep and use for coils was discussed, and an in-service is scheduled to go over in further detail.Staff did not believe that the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.Additional information received reported continuous saline flush was not administered and maintained as indicated in the ifu.Ifu prep and use for coils was discussed.The staff did not believe that the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.

• 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: 22998688
• Report Number: 9617601-2025-01370
• Device Sequence Number: 15655068
• Product Code: KRD
• UDI-Device Identifier: 00847536044906
• UDI-Public: (01)00847536044906(17)271028(10)229980572
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2025

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-3-8-HELIX
• Device Catalogue Number: NV-3-8-HELIX
• Device Lot Number: 229980572
• 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: 09/04/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2024
• 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