MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number APB-4-10-3D-SS

Device Problems Stretched (1601); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received a report that the axium coil has not progressed in the sheath into the microcatheter, which required replacement of the device.The next axium coil was inserted into the microcatheter and resistance was observed.When removing the device, it was observed that the spiral was "unmaking" inside the microcatheter.The device was removed and exchanged for another device.The device and accessory devices were prepared as indicated in the ifu.No patient symptoms or complications were reported as a result of this event.The patient was undergoing surgery for treatment of a fusiform, unruptured aneurysm in a previous communicator with an unknown max d iameter and an unknown neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Ancillary devices include a echelon 10 45 microcatheter.Additional information received reported that the doctor stated that about the spiral having dissolved: when the mircocoil passed inside the microcatheter, resistance was felt.By the time they removed the microspring from the device, the spring was undone, losing its original shape, and almost detached.

Manufacturer Narrative

H3: the axium prime coil and pushwire was returned for evaluation within the outer carton; inside of a biohazard bag and a shipping box.There was no echelon 10 catheter returned with the coil.Visual inspection/damage location details: the implant coil appeared to be detached from the pushwire.The shield coil appeared to be stretched.The implant coil was found severely stretched.The detachment element was found missing from the coil.The coin was not present against the lumen stop as it was pulling back.The pusher was found broken at the distal break indicator (manual detachment location); retained by the release wire; it appeared that the manual detachment was attempted at this location.The ai and coupler tubing were present and intact; it appeared that the mechanical detachment was not 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 (0.075mm @ 0.063mm; measured 0.086mm @ 0.127mm; measured 0.094mm @ 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 0.00462 ¿and found to be within specification.In addition, the echelon appeared to be compatible for use with the axium prime coil as it has a labeled inner diameter (id) of 0.017".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 implant coil and shield coil were found stretched.However, the root cause and cause for damage could not be determined.Based on the returned device, there was evidence of manual detachment as the pushwire was found broken at the manual 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.There was no non-conformance to specification identified that that led to the reported issues.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Since the catheter and detached element were not returned; any contribution of the catheter and detached element to the reported issues could not be determined.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 3D
• 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: 13060450
• MDR Text Key: 290459272
• Report Number: 2029214-2021-01653
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536008090
• UDI-Public: 00847536008090
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K081465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: APB-4-10-3D-SS
• Device Catalogue Number: APB-4-10-3D-SS
• Device Lot Number: A960800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/16/2020
• 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 Sex: Female