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

Model Number	NV-8-30-HELIX
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the coils (lot: 229646653 and 229927355) could not be detached by detacher, and physician refused to use back up deployment.There was non-detachment.The physician attempted to detach the coil with the instant detacher 4 times.The physician tried to detach with another instant detacher.There was no manual attempt at detachment via hypotube.Coil (lot: 228640128) could not be detached by detacher, and physician broke the hypotube, the coil did not separate instantly, while retrieving the coil from patient, the coil suddenly depolyed, and got stuck in microcatheter (lot: b615929).There was coil separation/break/premature detachment.The coil was removed from the patient.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was no friction or difficulty during delivery.The physician repositioned the coil 2 times.The physician attempted to detach the coil with the instant detacher 4 times and 1 time using the manual method.Two instant detachers were used.The physician tried to detach with another instant detacher twice.The physician did not rotate the delivery pusher during procedure.Coil (lot: b643400) while positioning the coil, the distal part of the pushwire bent.There was pusher kink/broken.There was friction or difficulty during testing or delivery.The damaged location was the pushwire distal segment.While positioning the coil (lot: d023257) the distal part of the pushwire bent.The coil (lot: d012378) could not be deployed by instant detacher and customer refused to deploy coil with manual method.There was non-detachment.The physician attempted to detach the coil with the instant detacher 4 times, and 4 times with the second instant detacher.There was no attempt at detachment via hypotube.Coil (lot: 230184317) could not be deployed by instant detacher and customer refused to deploy coil with manual method.There was non-detachment.The physician attempted to detach the coil with the instant detacher 3 times, and 2 times with the second instant detacher.There was no attempt at detachment via hypotube.Coil (lot: 230651057) could not be deployed by instant detacher and customer refused to deploy coil with manual method.The physician attempted to detach the coil with the instant detacher two times, and two times with the second instant detacher.There was no manual attempt at detachment via hypotube.The devices and any accessories were prepared as indicated in the ifu.There was no issue with the instant detacher.The continuous flush administered during the procedure.No patient symptoms or further complications were reported as a result of this event.The patient is alive with no injury.The patient was undergoing surgery for treatment of an unruptured pulmonary aneurysm with a max diameter of 27 mm and a 8 mm neck di ameter.It was noted the patient's blood flow was normal and vessel tortuosity was severe.
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
H3: device received, analysis is in progress.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 clarified that the coil with lot b643400 that experienced resistance during delivery had been used with the rebar catheter that had been used with a previous coil.The coil of lot 228640128 had a distal pusher bend.The resistance had been in the distal segment of the catheter.They felt resistance at the end of the coil coming out of the sheath.There was no kink/damage observed to the coil after removal.The catheter was discovered curly at the proximal part.There were no issues that resulted in the bent pushwires.Prior to coil non-detachment, there were no issues encountered.The pushwire damage was not observed after removal from the patient.It was noted that both instant detachers used were of the same lot #.The cause of the failure to detach, resistance, pusher bends was not determined.
Event or Problem Description
Additional information was received the coil (with lot#228640128) had resistance in the sheath.During preparation, the introducer sheath was held vertically when the implant coil was pulled back inside during hydration.
Additional Manufacturer Narrative
Product analysis (b)(4), item:30,lotno:228640128: as found condition: the concerto and rebar microcatheter devices were returned for analysis within a shipping box, inside of a sealed plastic biohazard pouch, an opened concerto inner pouch, and stuck inside of the rebar-18 microcatheter.Visual inspection/damage location details: the concerto device was returned stuck within the rebar-18 microcatheter.No pushwire was returned.The concerto implant coil was found to be advanced outside of the distal tip of the rebar-18 microcatheter stretched, damaged, and coated in dried blood.No other anomalies were observed.No damage or irregularities were observed with rebar-18 hub.The catheter body was returned bent/kinked at ~45.4cm and bent at ~119.5cm from the hub.The distal tip was found to be in good condition.Testing/analysis: during testing the rebar-18 microcatheter was hydrated and the implant coil was attempted to be extracted from the distal end.The implant coil met resistance and was unable to be extracted.The rebar-18 was then cut open to remove the implant coil.The concerto implant coil and the polypropylene filament were both found to be broken off from the detach element (loop, stick and ball).The rebar-18 microcatheter total length was measured to be 159.8cm, and the usable length was measured to be 153.6cm which was found to be within specification (specification- total length -159.5cm and usable length -153.0cm ±2.5cm).No further testing was able to be assessed with the rebar-18 microcatheter.Conclusion: based on the analysis performed, the customer report of ¿premature detach from non-detach" cannot be ruled out, as the implant coil was found to be broken within the rebar-18 microcatheter.During testing the implant coil was found to be stretched and broken, which may be an indication that there may have been resistance while extracting the implant coil out of microcatheter.A possible cause for the ¿non-detach¿ and the implant coil damage (stretching) could have been caused by the ¿coil shield wrapped around coil shell or proximal end of implant coil¿, while retracing the implant coil against resistance the device eventually broke off within the catheter body; however, the root cause of ¿premature detach from non-detach" could not be determined.No pushwire was returned for assessment; therefore, any contribution the subassemblies had towards the ¿non-detachment¿ or the ¿premature detachment¿ were unable to be assessed.The report states that ¿the physician attempted to detach the coil with the instant detacher 4 times and 1 time using the manual method.Two instant detachers were used¿.No instant detachers were returned for assessment; therefore, any c ontribution the instant detacher had towards the ¿non-detachment¿ was unable to be verified.A few other possible causes of ¿non-detach¿ are but not limited to, damaged pusher, and pushwire rotation.The report notes that ¿the physician repositioned the coil 2 times¿ but also noted that ¿the physician did not rotate the delivery pusher during procedure¿.A few possible causes of ¿premature det achment¿ are but not limited to tortuous anatomy, coil is not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, and user advances the coil against resistance.The root cause could not be determined.The customers report of ¿catheter resistance¿ was able to be confirmed.A possible cause for the catheter resistance¿ may have been caused by the catheter body damage (bends/kinds) found in the middle segment of the catheter body or concerto pusher/implant damage; however, the root cause was unable to be determined.A few other possible causes of ¿catheter resistance¿ are but not limited to patient vessel tortuosity, and flush rate too low.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 CA 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc CA 22210 ; MX 22210
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 22322795
• Report Number: 2029214-2025-01454
• Device Sequence Number: 18341407
• Product Code: KRD
• UDI-Device Identifier: 00847536044975
• UDI-Public: (01)00847536044975(17)270409(10)228640128
• 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
• Report Date (Section B): 08/22/2025

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-8-30-HELIX
• Device Catalogue Number: NV-8-30-HELIX
• Device Lot Number: 228640128
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 06/26/2025; 08/16/2025
• Initial Report FDA Received Date: 06/24/2025
• Supplement Report FDA Received Date: 07/24/2025; 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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: Male