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

Model Number APB-4-8-3D-SS

Device Problems Use of Device Problem (1670); Separation Failure (2547)

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

Event Date 05/10/2023

Event Type  malfunction  

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

Event Description

Medtronic received information that an axium coil could not be detached.When the hypotube was broken as the healthcare provider (hcp) always does, there was no inner wire to pull and detach the coil.So the coil can not be detached and was able to be pulled out of the aneurysm.The devices were prepared according to the instructions for use (ifu).The patient's blood flow and vessel tortuosity were normal.No patient symptoms or complications were reported.

Manufacturer Narrative

Product analysis #: (b)(4): as found condition (condition of returned device): an axium prime coil was returned for analysis within a shipping box; within a sealed tyvek biohazard pouch; within a secondary sealed biohazard bag; within an opened axium prime coil inner pouch and within a dispenser track.The axium prime coil was returned within the introducer sheath.Visual inspection/damage location details: upon inspection the axium implant coil pushwire was found to be broken at ~14.2cm from distal tip.This is indicative a manual detachment attempt was made at this location.The coin was found still against the lumen stop.The shield coil was found intact with the implant coil still attached.The implant was found to be stretched and damaged.No other anomalies were observed.Testing/analysis: the distal outer jacket was removed, and a manual detachment was then attempted by retracting the release wire and the release wire successfully detached implant coil.Conclusion: based on the analysis performed, the customers report of ¿non-detachment¿ was confirmed as the pusher was returned with the implant coil still attached.However, the implant coil was successfully detached manually during testing.However, the root cause for ¿non-detachment¿ could not be determined.The implant coil was found damaged.Possible causes for damage are device was not hydrated, continuous flush was not administered during procedure, advancing device against resistance or damaged during shipment.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: 16907324
• MDR Text Key: 315002951
• Report Number: 2029214-2023-00776
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00847536008168
• UDI-Public: 00847536008168
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• Report Date: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: APB-4-8-3D-SS
• Device Catalogue Number: APB-4-8-3D-SS
• Device Lot Number: 224649685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2023
• Initial Date FDA Received: 05/10/2023
• Supplement Dates Manufacturer Received: 07/11/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2022
• 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 Sex: Male