MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-2.5-4-3D
Medical Device Problem Codes	Break (1069); Stretched (1601); 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	05/30/2024
Type of Reportable Event	Malfunction
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
Medtronic received a report that the axium spring coil was stretched during the insertion of the y-valve into the microcatheter.It was reported coil separation/break/premature detachment occurred.The implant coil is in the y-valve of the microcatheter.There was no surgical or medicinal intervention required.The pushwire was not bent or broken.There was friction or difficulty during delivery.The physician did not reposition the coil.The physician did not attempt to detach the coil.The physician did not rotate the delivery pusher during the procedure.The continuous flush was administered during the procedure.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).Ancillary devices include an 8f sheath, 6f navien guide catheter, echelon microcatheter, synchro2 guidewire.
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 was received that the cause of the stretch was undetermined.Catheter resistance occurred at the hub.The coil was separated into two or more pieces.The coil prematurely detached.It was noted that after the coil was replaced, the echelon catheter was used normally.
Additional Manufacturer Narrative
Product analysis: as found condition (condition of returned device): the axium implant coil was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within an opened axium implant coil inner pouch and within a dispenser track.The echelon-10 micro catheter used in the event was not returned.Visual inspection/damage location details: no bends or kinks were found with the axium implant coil pushwire.The implant coil was found to be stretched and damaged within the introducer sheath.The axium implant coil could not be pushed out further from the introducer sheath for additional evaluation as it was found to be stuck.No other anomalies were observed.Testing/analysis (including sem reports): the axium implant could not be used for resistance testing with an in-house micro catheter due to its damaged condition.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck at cath.Hub¿ was confirmed.Possible causes for coil resistance at catheter hub are, but not limited to, failure to hydrate the coil prior to use, failure to utilize continuous flush, failure to use a compatible microcatheter for delivery, and use of an improper hubbing technique (over tightening of the rhv/sheath firmly seated into hub).Improper hubbing technique could not be ruled out as a potential root cause for the event.Based on the analysis performed, the customers report of ¿coil separation/break¿ was unable to be confirmed as the pushwire was returned with the implant coil still attached.Based on the analysis performed, the customers report of ¿coil stretch¿ was confirmed.Possible causes for ¿coil stretch¿ are patient vessel tortuosity, coil not retracted in a one-to-one motion with the implant pusher during repositioning, or user advances the coil against resistance.Based on the analysis performed, the customers report of ¿premature detachment¿ was unable to be confirmed as the axium implant coil was still attached.The echelon-10 micro catheter has a labeled id (inner diameter) of 0.017" with two separate marker bands.Per axium detachable coil ifu (instructions for use): ¿axium detachable coils should be delivered through a micro catheter with a minimum inside diameter of 0.0165¿.Therefore, the ec helon-10 micro catheter was found to be compatible for use with the axium implant coils and can be ruled out as a potential cause.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.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: justin ellis ; 9775 toledo way; irvine, CA 92618 ; 7635265677
• MDR Report Key: 19447394
• Report Number: 2029214-2024-01015
• Device Sequence Number: 18269597
• Product Code: KRD
• UDI-Device Identifier: 00847536037656
• UDI-Public: 00847536037656
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• 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): 09/06/2024

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 Expiration Date: 09/17/2026
• Device Model Number: QC-2.5-4-3D
• Device Catalogue Number: QC-2.5-4-3D
• Device Lot Number: 227350103
• 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: 05/31/2024
• Supplement Date Received by Manufacturer: 06/07/2024; 07/23/2024; 09/04/2024
• Initial Report FDA Received Date: 06/03/2024
• Supplement Report FDA Received Date: 07/01/2024; 08/07/2024; 09/06/2024
• Date Device Manufactured: 09/17/2023
• 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