MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number APB-3-8-HX-ES

Device Problems Stretched (1601); Detachment of Device or Device Component (2907); Unintended Movement (3026); Migration (4003)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/06/2023

Event Type  Injury  

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 Description

Medtronic received a report that the axium coil was not sitting in the vessel as the physician wanted it to.He went to pull the coil out, but it stretched and prematurely detached and remained in the patient.There was no friction or difficulty during testing or delivery.Continuous flush was administered throughout the procedure.A couple of days later, the axium migrated into the m1 and had to be retrieved with a solitaire.The patient is currently doing well.The axium coil and any accessories were prepared as indicated in the instructions for use (ifu).  the patient was undergoing surgery for embolization of vessels feeding tumor.It was noted the patient's blood flow was normal and vessel tortuosity was normal.  ancillary devices include a cerenovus mpc 5f guide catheter, echelon 14 microcatheter, and a synchro select guidewire.

Manufacturer Narrative

H3: product analysis: equipment used: video inspection system (m-81805), ruler (m-83360), camera (panasonic lumix dmc-zs5) as found condition: the axium implant coil and unknown stent were returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within two resealable plastic biohazard pouches.The echelon-10 micro catheter used in the event was not returned for analysis.Visual inspection/damage location details: the stent pusher was found cut at ~7.3cm from the attachment zone.The axium implant coil was found entangled with the distal stent.The axium implant was found stretched, damaged, and broken.The axium pusher was not returned for analysis.Conclusion: the customer report of ¿coil loop in parent vessel¿ could not typically be confirmed through device analysis.Possible causes for coil loop in vessel are patient vessel tortuosity, catheter tip under stress, catheter kickback, or catheter placement.Customer reported there was no friction or difficulty was experienced during testing/delivery, continuous flush was administered, devices were prepared per ifu, and vessel tortuosity was normal.Therefore, the likely cause could not be determined.The customer report of ¿premature detachment" and ¿coil stretch¿ were confirmed.It is possible the coil became entrapped within the vessel or with other devices, causing the coil to stretch and break when the customer attempted to retract the coil.It is likely the returned stent was used to retrieve the coil once it broken and migrated within the vasculature.As the echelon-10 micro catheter used in the event was not returned for analysis, any contribution of the micro catheter towards the failures could not be determined.The echelon-10 is compatible for use with the axium coil as it has an inner diameter of 0.0165¿.H6.Coding updated based on analysis results.**correction made to annex f/imf coding** 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.

• Brand Name: AXIUM PRIME BRPL HLX
• Type of Device: 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: 17998533
• MDR Text Key: 326423530
• Report Number: 9612164-2023-04839
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536021099
• UDI-Public: 00847536021099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APB-3-8-HX-ES
• Device Catalogue Number: APB-3-8-HX-ES
• Device Lot Number: 225821904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 44 KG