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

Model Number	APB-1.5-4-3D-ES
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis #278819428:equipment used: video inspection system (m-81850), ruler (m-83360), camera (panasonic lumix dmc-zs5), drawing(s) referenced: n/a as found condition: the axium prime coil device was returned for analysis within a shipping box; within an unsealed plastic biohazard pouch; within an opened axium prime inner pouch (model: apb-1.5-4-3d-es lot: 222676055) and within an introducer sheath.Visual inspection/damage location details: no damages or irregularities were found with the introducer sheath.No damages or irregularities were found with the axium prime pusher or shield coil.The axium prime implant coil was found broken from the detach element.The implant coil was found severely stretched and damaged with the polypropylene filament also broken.Testing/analysis: due to the severe damages found to the axium prime implant coil, conformation to specifications could not be assessed.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿incorrect part¿ could not be confirmed through device analysis.The implant coil was found stretched/kinked/broken.As customer did not report any damages during preparation and inspection, it is likely the damages occurred during handling or during return shipping.There is an indication that the event is related to a potential manufacturing issue, and a dhr review will be performed.Ngod10 2022-07-31 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 or Problem Description
Medtronic received information that a axium coil was not the size of the outer package.The patient was being treated for an aneurysm in the ophthalmic artery segment.The max diameter was 2mm and the neck diameter was 3mm.Patient blood flow was normal and vessel tortuosity was moderate.The devices were prepared as indicated in the instructions for use (ifu).  the coil was pushed out from the microcatheter with a very short length, it was not the outer package size.No symptoms were reported.

• Brand Name: AXIUM PRIME BARE PL 3D
• Common Device Name: 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: 15234494
• Report Number: 2029214-2022-01381
• Device Sequence Number: 14616359
• Product Code: KRD
• UDI-Device Identifier: 00763000313661
• UDI-Public: 00763000313661
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2024
• Device Model Number: APB-1.5-4-3D-ES
• Device Catalogue Number: APB-1.5-4-3D-ES
• Device Lot Number: 222676055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2022
• Initial Report FDA Received Date: 08/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Sex: Female