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

Model Number APB-2-3-3D-ES

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problems Stroke/CVA (1770); Obstruction/Occlusion (2422)

Event Date 04/22/2023

Event Type  Death  

Event Description

Medtronic received a report that the axium prime coil was unable to be detached and then detached inside the catheter.The patient was undergoing treatment for a ruptured, saccular aneurysm located in the anterior communicating artery.The max diameter and neck diameter were 2mm.The patient's blood flow and vessel tortuosity were normal.It was reported that  the doctor inserted the microcatheter with the microguide and positioned it in the aneurysm, removed the microguide and inserted the coil previously hydrated by the microcatheter they began to detach it inside the aneurysm until the 3d basket was assembled.They tried releasing the coil with the instant detacher.A second instant detacher was also used, but the coil could not be detached.No detachment attempts were made with the manual method.It was stated that there were no problems with the instant detacher.They then began to withdraw the pusher from the coil, and when it has withdrawn a little more than 3cm, it began to disarm and retract through the microcatheter.The doctor tried to push it to insert it inside the aneurysm, but they had no control of the coils because it was only holding onto the filament.After this, the coil came out of the aneurysm and immediately traveled to the callosomarginal artery, completely occluding it.The doctor immediately a solitaire stent retriever and managed to capture and extract the coil.They performed a control image and complete occlusion of the callosomarginal artery was observed.They proceeded to occlude the aneurysm with another coil, and later tried to uncover the callosomarginal artery with chemical thrombolysis without successfully making it permeable.The patient experienced a stroke. all systems are removed and the patient was transferred to the icu.The patient status was noted to be alive with injury. the devices were prepared according to the instructions for use (ifu).

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

Additional information received reported that the patient died on (b)(6) 2023, with a diagnosis of sudden death.There was no problem before the coils came off.No damage was observed, the coil appeared to be fine.

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

Product analysis #291249414:¿ equipment used: video inspection system (m-85519) with microscope, ruler (m-83361), camera (panasonic lumix dmc-zs5) ¿ drawing(s) referenced: dwgs50566 rev.A; dwgs50520 rev.U; dwgs31195 rev.B; dwgs50523 rev.E ¿ as found condition: the pushwire wad returned within the inner pouch; inside of a biohazard bag and a shipping box.There was no implant coil returned with the pushwire.¿ visual inspection/damage location details: the implant coil appeared to be detached from the pushwire.The shield coil found intact with no damage.The coin was not present against the lumen stop as it was pulling back.The break indicator (manual detachment location) was found intact; indicative of manual detachment was not attempted at this location.The ai and coupler tubing were present but not intact; indicative of mechanical detachment was attempted at this location.¿ testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.074mm @ 0.063mm; measured 0.085mm @ 0.127mm; measured 0.097mm @ 0.275mm) and found to be within specifications.The inner diameter of the lumen stop, and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured to be 0.00271¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00459¿ and found to be within specification.No other anomalies were observed.¿ conclusion: based on the analysis performed, the customer complaint was confirmed.However, the cause could not be determined as the pushwire was returned without the implant coil.The ai and coupler tubing was broken at the mechanical detachment location with the coin pulled back from the lumen stop.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.Since the implant coil was not returned; any contribution of the implant coil to the reported issue could not be determined.Ls 2023-07-17 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

Additional information received report the patient died in the intensive care unit (ica).It was noted that the patient's death was "due to another pathology" and was not related to the axium coil detachment issues.

Manufacturer Narrative

Associated with mdr#: 2029214-2023-00684.B5.Updated with additional information received.H6.Device eval code added based on additional information received.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.

• Brand Name: AXIUM PRIME BRPL 3D
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc CA 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 16803544
• MDR Text Key: 313904271
• Report Number: 2029214-2023-00683
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536021181
• UDI-Public: 00847536021181
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APB-2-3-3D-ES
• Device Catalogue Number: APB-2-3-3D-ES
• Device Lot Number: 223740453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2022
• 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 Outcome(s): Required Intervention; Hospitalization; Death; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 65 KG