MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	QC-10-30-3D
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the axium coil stretched and was detached.The patient was undergoing surgery for treatment of a  arteriovenous fistula grade 2.The abnormality was not in an eloquent region.It was noted the patient's blood flow was normal and vessel tortuosity was normal.It was reported that the when treating the left arteriovenous fistula, the axium spring coil and onyx were used to occlude the left transverse sinus.When filling the spring coil, the qc-10-30-3d was stretched during the adjustment process, so it was detached immediately, and another spring coil was continued to be filled to block the stretched segment into the fistula.It was reported coil s eparation/break/premature detachment occurred.The coil was implanted in the intended location.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 did reposition the coil one time.The physician did attempt to detach the coil by using the manual method at detachment one time.The physician did not attempt to detach the coil with the instant detacher.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).No patient symptoms or further complications were reported as a result of this event.  ancillary devices include a 6f guilding guide catheter and synchro 14 guidewire.
Additional Manufacturer Narrative
H3: product analysis of qc-10-30-3d, lotno: 226008922.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.The actuator interface was found securely attached to the coupler tube.The break indicator was found still intact.There were no evidence of detachment attempts at these locations.No damages or irregularities were found with the pusher.The shield coil was found undamaged.The implant coil was found still attached to the pusher.The implant coil was found damaged and severely stretched with the polypropylene filament broken.Testing/analysis: a manual detachment was then attempted by breaking the pusher at the break indicator, and the release wire was retracted; detaching the implant coil with no issues.No other anomalies could be observed.Conclusion: based on the analysis performed, the customer report of ¿premature detachment" could not be confirmed.The implant coil was returned still attached to the pusher.In addition, no issues were observed when detaching the coil using the manual method.The customer report of ¿coil stretch¿ was confirmed.Potential causes for the severe coil stretching found include, but not limited to lack of hydration before procedure, user does not maintain sufficient continuous flush, tortuous anatomy, coil not retracted in a one-to-one motion with the implant pusher during repositioning, pushwire rotation, user advances/retracts the coil against resistance, or damaged micro catheter.Customer reported vessel tortuosity as normal, no friction/difficulty during delivery, continuous flush was administered, and devices were prepared per ifu.Therefore, the likely cause could not be determined.As the echelon-10 micro catheter used during the event was not returned for analysis, any contribution of the echelon-10 towards the failures could not be assessed.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.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.
Event or Problem Description
Additional information was received stating that the cause of the stretch was not determined.Due to normal process operation, it was suspected that there was a quality control issue with the spring coil.The axium coil detached on it's own.There were not any issues that resulted in the damage that was found.The coil was implanted.A total of 36 coils were implanted before and after this coil malfunctioned.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18816390
• Report Number: 9612164-2024-01039
• Device Sequence Number: 14525384
• Product Code: KRD
• UDI-Device Identifier: 00836462010475
• UDI-Public: 00836462010475
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 05/09/2024

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: 02/18/2026
• Device Model Number: QC-10-30-3D
• Device Catalogue Number: QC-10-30-3D
• Device Lot Number: 226008922
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 03/04/2024; 04/11/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/22/2024; 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2023
• 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 Age: 51 YR
• Patient Sex: Male
• Patient Weight: 72 KG