MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number APB-4-12-HX-SS

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/22/2022

Event Type  malfunction  

Event Description

Medtronic received information regarding an axium coil that detached prematurely.The patient was undergoing a coil embolization procedure to treat an unruptured saccular internal carotid artery (ica)  c6-c7 segment aneurysm.The aneurysm max diameter was 7mm and the neck diameter was 5mm.Blood flow and vessel tortuosity were normal.It was reported that the axium coil and all accessory devices were prepared as indicated in the instructions for use (ifu).The coil was accidentally detached in the microcatheter during the delivery process, resulting in the tail of the coil floating in the parent vessel.It was noted that there was no friction or other difficulty during delivery of the coil.The physician had not attempted to reposition or detach the coil.The physician did not rotate the delivery pusher and the pusher was not bent or broken.Continuous catheter flush was administered during the procedure.A stent was deployed to secure the coil.There were no patient symptoms related to the event.Ancillary device: headway 17 microcatheter.

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.

Event Description

Additional information received reported that the coil was implanted in the body.The stent deployed was to secure the coil.

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: ¿ as found condition: the pushwire was returned inside of a biohazard bag and a shipping box.The implant coil was not returned as it was remained in the patient.¿ visual inspection/damage location details: the implant coil was found 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 pusher was found broken at the break indicator (manual detachment location); with the release wire pulling back.The ai and coupler tubing were present and intact.¿ testing/analysis: under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.075mm @ 0.063mm; measured 0.086mm @ 0.127mm; measured 0.099mm @ 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 0.00269¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00460¿and found to be within specification.All other subassemblies appeared to be normal, and no other anomalies were observed.¿ conclusion: based on the analysis performed, the customer complaint was confirmed as the pushwire was returned with the implant coil already detached from the pushwire.The pushwire was found broken at the manual detachment location with the coin pulled back from the lumen stop.The cause could not be determined.Pulling back of the coin from the lumen stop may have contributed to the detachment of the implant coil from the pushwire.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): 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 15743861
• MDR Text Key: 307630503
• Report Number: 2029214-2022-01893
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536008137
• UDI-Public: 00847536008137
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K081465
• 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
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: APB-4-12-HX-SS
• Device Catalogue Number: APB-4-12-HX-SS
• Device Lot Number: A922547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/15/2022; 03/09/2023
• Supplement Dates FDA Received: 12/09/2022; 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2019
• 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: 55 YR
• Patient Sex: Female