MAUDE Adverse Event Report: MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR AXIUM PRIME BRPL 3D; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-2-3D-ES
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the coil got stuck inside the microcatheter, eventually a detachment did occur inside the catheter.The device was prepared as indicated in the package insert.Ancillary devices include: headway 17 microcatheter.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H3:¿ as found condition: the axium prime coil was returned for analysis within a shipping box, within a primary plastic resealable pouch, within an opened axium prime outer carton (221070140), and within a secondary plastic resealable pouch.A (microvention terumo) headway 17 catheter was returned with the axium prime coil.¿ visual inspection/damage location details: the axium prime pusher¿s actuator interface (ai) and hypotube break indicator (hbi) were found intact.No bends or kinks were found with the pusher.The release wire coin was found against the lumen stop, the shield coil was in good condition, and the implant coil was detached.The implant coil was not returned.The release wire distal tip was extending out from the distal end of the pusher.The release wire was removed from the pusher and the coin was found in good condition.The pusher lumen stop and retainer ring inner diameters were examined and found in good condition.The headway catheter was examined.The catheter hub was found in good condition.No kinks were found with the catheter body.The catheter distal tip was found bent.¿ testing/analysis: the headway catheter was flushed, blood and water exited from the distal tip.An in-house 0.016¿ mandrel was inserted through the headway catheter without issue.¿ conclusion: based on the device analysis and reported information, the customer¿s ¿premature detachment¿ report was confirmed.As the axium prime coil was advanced against resistance this would have likely contributed to the event.Advancing the device against resistance cause the implant coil to detach.The implant coil was not returned; therefore, analysis could not be performed and conformance to specification could not be assessed.Possible contributing factors to ¿coil resistance¿ include using an incompatible device for delivery, tortuous anatomy, failure to maintain a continuous flush or failure to hydrate the axium prime coil before use.However, additional information was not provided.The headway 17 catheter has a labeled id (inner diameter) of 0.017¿, as per an online source.Per the axium prime coil ifu (instructions for use): ¿axium prime detachable coils should be delivered through a microcatheter with a minimum inside diameter of 0.0165¿-0.017¿ with two marker bands¿.Therefore, the headway 17 catheter was found to be compatible for use with the axium prime coil.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
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR; 9779 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS D/B/A EV3 NEUROVASCULAR; 9779 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14379857
• Report Number: 9612164-2022-01790
• Device Sequence Number: 12448282
• Product Code: KRD
• UDI-Device Identifier: 00847536021174
• UDI-Public: 00847536021174
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2022

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: 10/30/2023
• Device Model Number: APB-2-2-3D-ES
• Device Catalogue Number: APB-2-2-3D-ES
• Device Lot Number: 221070140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 05/25/2022
• Initial Report FDA Received Date: 05/12/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown