MAUDE Adverse Event Report: MEDTRONIC MEXICO AXIUM PRIME BRPL HLX; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	APB-2-6-HX-ES
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the axium coil got stuck halfway into the microcatheter.Retrieved back to the delivery sheath and pushed out the spring coil, it was found that a part of the tip was stretched.Scissors was used to minus a section, and delivered into the microcatheter, it was still stretched.Then an axium coil was replaced to stuff in the tumor, and the angiography showed no imaging of the tumor, and then the stent was deployed.After anteroposterior and lateral angiography, the operation ended.The axium coil and any accessories were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of an amorphous, unruptured  left middle cerebral artery m2 aneurysm with a max diameter of 4.1mm and a 4mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was normal.Ancillary devices include a 6f guiding + echelon + sl10 microcatheter.Additional information received reported that the resistance was in the proximal end of the catheter.The coil came out of the inducer sheath smoothly.It was noted that there was a little damage observed after removal.
Additional Manufacturer Narrative
Product analysis #705778773: equipment used: vis m-81805, 203cm ruler m-83360 as found condition (condition of returned device): the axium prime implant coil was returned for analysis within a shipping box and returned within a sealed plastic biohazard pouch.No micro catheter was returned within the shipping box.Damage location details: the axium prime implant coil was returned within the introducer sheath which was found to be applied correctly with the wavelock facing towards the proximal end of the pushwire.The pushwire was found to be bent at ~18.1cm and bent at ~63.4cm from the proximal end; however, the pushwire was found to be bent within the introducer sheath at ~53.8cm from the distal end.The axium prime implant coil was found to be stretched and damaged within the introducer sheath; in addition, the implant coil polypropylene filament was found to be still attached to the pushwire.The axium prime implant coil distal tip was found to be missing.The customer noted that part of the distal tip was stretched and removed with scissors.The axium prime implant coil was not able to be pushed out of introducer sheath due to resistance encountered while advancing the coil; therefore, the pushwire was retracted from the introducer sheath within out issues.Testing/analysis (including sem reports): the axium prime implant was unable to be tested with an in-house microcatheter due to its returned condition (damaged) conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance¿ and ¿coil stretched¿ were both confirmed.The axium prime coil was returned with the pushwire bent and the coil stretched.Advancing the coil against resistance could lead to damage and stretching.Possible causes for resistance are but not limited to incompatible catheter, lack of hydration before procedure, user does not maintain continuous flush, tortuosity anatomy and damage or kink to pushwire.Information regarding if a continuous flush was not reported.It was noted the patient's blood flow was normal and vessel tortuosity was normal.The customer reported that the device was cut, and the damaged part was removed.This may be a possible cause for resistance due to the device being tampered with; however, this could not be reproduced or confirmed.The customer reported device and any accessory devices were prepared as indicated in the ifu.The echelon 10 catheter appeared to be compatible for use with the axium prime coil as it has a labeled inner diameter (id) of 0.0165¿- 0.017¿ with two band markers; therefore, the cause for resistance was unable to be d etermined.(durana27 2023-10-11) 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 HLX
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 18050842
• Report Number: 9612164-2023-04979
• Device Sequence Number: 8026374
• Product Code: KRD
• UDI-Device Identifier: 00763000313890
• UDI-Public: 00763000313890
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2026
• Device Model Number: APB-2-6-HX-ES
• Device Catalogue Number: APB-2-6-HX-ES
• Device Lot Number: 226309177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2023
• 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: 73 YR
• Patient Sex: Female
• Patient Weight: 50 KG