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

Model Number APB-1-3-HX-ES

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/09/2023

Event Type  malfunction  

Event Description

Medtronic received a report that two axium coils prematurely detached.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm located in the right internal carotid artery with a max diameter of 5.1 mm and a 3.8 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.It was reported that the patient underwent aneurysm embolization.The microcatheter was in place, and the coil (lot # 224889205) was detached prematurely when the coil was delivered.It was replaced without causing injury to the patient.It was reported coil separation/break/premature detachment occurred.It was noted the coil remains in the patient.The coil was not implanted in its intended location.It was reported the stent attached to the vessel wall in the parent artery.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 not reposition the coil.The physician did not attempt to detach the coil.It is unknown if the physician rotated the delivery pusher during the procedure.The continuous flush was administered during the procedure. it was reported the patient underwent aneurysm embolization.The microcatheter was in place, and the coil (lot # 225113020) was detached prematurely when the coil was delivered.It was replaced without causing injury to the patient.It was reported coil separation/break/premature detachment occurred.It was noted the coil remains in the patient.The coil was not implanted in its intended location.It was reported the procedure was stent assisted.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 rotated 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 cook sheath, johnson and johnson guide catheter, echelon microcatheter, and sy-2 guidewire.

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.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

Additional information received that it was clarified both coils remain in the patient.Where in the internal carotid artery do the coil(s) remain is unknown.It was a problem with the product, as it didn't reach the lesion, and it was detached prematurely.

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.

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 two axium coils prematurely detached.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm located in the right internal carotid artery with a max diameter of 5.1 mm and a 3.8 mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was moderate.  it was reported that the patient underwent aneurysm embolization.The microcatheter was in place, and the coil  (lot # 224889205) was detached prematurely when the coil was delivered.It was replaced without causing injury to the patient.It was reported coil separation/break/premature detachment occurred.It was noted the coil remains in the patient.The coil was not implanted in its intended location.It was reported the stent attached to the vessel wall in the parent artery.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 not reposition the coil.The physician did not attempt to detach the coil.It is unknown if the physician rotated the delivery pusher during the procedure.The continuous flush was administered during the procedure.It was reported the patient underwent aneurysm embolization.The microcatheter was in place, and the coil (lot # 225113020) was detached prematurely when the coil was delivered.It was replaced without causing injury to the patient.It was reported coil separation/break/premature detachment occurred.It was noted the coil remains in the patient.The coil was not implanted in its intended location.It was reported the procedure was stent assisted.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 rotated 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 cook sheath, johnson and johnson guide catheter, echelon microcatheter, and sy-2 guidewire.2023-06-12 e1 (rep, for, hcp): additional information received that to clarify the coils remain in the patient.It is unknown if there are future medicinal/surgical intervention planned to remove the coils.The anatomical location of the coils is the internal carotid artery.There are no procedural / post-procedural imaging (ct, angio, etc.) available.For axium coil (lot # 225113020) the resistance location is unknown.The coil came out of the introducer sheath smoothly.There was no kink/damage to the coil observed after removal.The echelon catheter lot number was b476715.

Manufacturer Narrative

H3: product analysis #(b)(4):equipment used: vis (m-78210), 203cm ruler (m-83361) as found condition (condition of returned device): one axium implant coil and one axium prime coil were returned for analysis within a shipping box; within a sealed plastic biohazard pouch and within dispenser tracks.The axium coils were returned without introducer sheaths.Visual inspection/damage location details: due to the condition in which the axium coils were returned, it could not be determined which pli or product event each axium coil corresponds to.(coil 1) the actuator interface, positive load indicator and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium coil pushwire was found to be kinked at 2.8cm and broken but retained by release wire at break indicator.This is indicative manual detachment was attempted.The coin was found to be pulled back from lumen stop and not returned.The implant coil was already detached and not returned.The shield coil was found to be broken.No other anomalies were observed.(coil 2) the actuator interface and coupler tube were found to be intact.This is indicative mechanical method detachment was not attempted.The axium coil pushwire was found to be broken but retained by release wire at load indicator.This is indicative manual detachment was attempted.The coin was found to be pulled back from lumen stop and not returned.The implant coil was already detached and not returned.The shield coil was found to be broken.No other anomalies were observed.Testing/analysis (including sem reports): (coil 1) under the microscope, the outer jacket was then removed.The lumen stop appeared to be visually acceptable.The retainer ring was found to be visually acceptable; however, unable to be measured accurately.(coil 2) under the microscope, the outer jacket was then removed.The lumen stop appeared to be visually acceptable.The retainer ring was found to be visually acceptable; however, unable to be measured accurately.Conclusion: based on the analysis performed, the customers report of ¿premature detachment¿ was confirmed as the axium coils was returned with the implant already detached and the cause could not be determined.Since the implant coil and included detach element were not returned for analysis, any contributing factors could not be determined.A possible cause for premature detachment is the coil not being retracted in a one-to-one motion with the implant pusher during repositioning.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: 17097772
• MDR Text Key: 316868558
• Report Number: 9612164-2023-02494
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00763000313807
• UDI-Public: 00763000313807
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APB-1-3-HX-ES
• Device Catalogue Number: APB-1-3-HX-ES
• Device Lot Number: 225113020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2022
• 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 Age: 69 YR