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

Model Number	PC-2-6-3D
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is reported at this time based on analysis results which indicate a reportable event.Product analysis:¿ equipment used: video inspection system (m-78210) with microscope, ruler (m-83361), camera (panasonic lumix dmc-zs5) ¿ as found condition: the axium coil was returned for evaluation within the introducer sheath and inner pouch; inside of a biohazard bag and a shipping box.¿ visual inspection/damage location details: the implant coil appeared to be detached from the pushwire.The implant coil was found to be damaged and stretched with the polypropylene filament intact.The shield coil was 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 distal break indicator (manual detachment location); 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.Bends were found along the length of the pushwire.All other subassemblies appeared to be normal, and no other anomalies were observed.¿ testing/analysis: the axium coil was removed from the sheath with difficulty.The ¿wave lock¿ portion of the introducer sheath was present near the proximal end.The implant coil tip od (outer diameter) was measured to be 0.0114¿ which is within specifications.The introducer sheath id (inner diameter) was measured to be 0.0190" (0.44mm) found to be within specifications.The detach element was in good shape and the detachment ball was measured to be 0.0038" and found to be within specifications.Under the microscope, the outer jacket was then removed to gain access the coin.The coin was measured in 3 locations (0.072mm @ 0.063mm; measured 0.083mm @ 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 0.00265¿ and found to be within specification.The retainer ring inner diameter (id) was measured to be 0.00459¿ and found to be within specifi cation.¿ conclusion: based on the analysis performed, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed as the implant coil was found stuck inside the introducer sheath.The returned axium coil was found to be damaged and stretched.The pushwire was damaged at several locations.However, the cause root cause and the cause for damages could not be determined.The customer did not report any issues pushing the implant coil out from the introducer sheath during the hydration process.Therefore, it is possible that damages occurred during preparation or due to an improper hubbing technique (over tightening of the rhv).In addition, the implant coil also found detached from the pushwire.Additionally, 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 led to the reported issue.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 or Problem Description
Medtronic received information regarding an axium coil that had resistance in the sheath.The patient was undergoing a coil embolization procedure to treat a dural arteriovenous fistula.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 could not be advanced out of the sheath into the rhv/microcatheter and was stuck.The coil was removed and tried in vitro on the table but still could not be pushed out of the introducer sheath.There was no harm or injury to the patient.Ancillary devices: 6f sheath, 6f neuron max 088 sheath, 5f sophia guide catheter, headway duo microcatheter additional information received reported that the coil was prepared like described above (as per ifu).When the coil was inserted into the microcatheter¿s rhv it would not advance in the introducer sheath and was getting stuck to where only the coil could be pushed out but it wouldn¿t advance any further.Coil was removed and they tried advancing it on the table to see what the issue was and same thing happened.Looked as if it was getting stuck at the proximal end of the introducer sheath and pusher wire.Coil didn¿t enter patient and was removed from table.

• Brand Name: AXIUM PGLA 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: 15201271
• Report Number: 2029214-2022-01331
• Device Sequence Number: 15056128
• Product Code: KRD
• UDI-Device Identifier: 00847536033184
• UDI-Public: 00847536033184
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081465
• 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): 08/09/2022

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: 06/16/2024
• Device Model Number: PC-2-6-3D
• Device Catalogue Number: PC-2-6-3D
• Device Lot Number: B222529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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: 38 YR
• Patient Sex: Female