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

Model Number	APB-1.5-4-HX-ES
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: as found condition: the axium prime pusher and headway-17 micro catheter were returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The axium prime pusher was returned within the headway-17 micro catheter.Visual inspection/damage location details: no damages or irregularities were found with the headway-17 hub.The axium prime pusher was found extending out the hub ~35.0cm.The headway-17 catheter body was found bent at ~40.5cm from the proximal end.The catheter was found flattened at ~95.4cm and ~130.8cm from the proximal end and flattened at ~1.5cm from the distal end.The axium prime pusher was found broken distal to the break indicator with the release wire also broken.The proximal segment was not returned for analysis.The coin was found fully retracted out of the lumen stop.The shied coil was found stretched and entangled with the headway-17 inner liner.Testing/analysis: the axium prime coil was found stuck within the micro catheter.After removal the damaged inner liner was found entangled with the shield coil.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿coil resistance/stuck in catheter¿ was confirmed.The cause of the resistance was found to be the damaged inner liner becoming entangled with the axium prime pusher shield coil.The cause of the inner liner damage and the shield coil damage could not be determined.The micro catheter was also found bent and flattened, which could have contributed towards the reported resistance.The headway-17 has an inner diameter of 0.017¿ and is 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.
Event or Problem Description
Medtronic received a report that the axium coil push rod could not be withdrawn from the microcatheter.The patient was undergoing surgery for treatment of a saccular, ruptured aneurysm in the right posterior communicating artery with a max diameter of 5 mm and a 3 mm neck diameter.It was noted the patient's blood flow was low and vessel tortuosity was moderate.It was reported that after the spring coil embolization was completed, it was successfully detached, but the spring coil push rod could not be withdrawn from the microcatheter.In the end, the microcatheter and the push rod could only be withdrawn from the body together; the microcatheter used was mv company's headway 17.They were sent back to the company together.This surgery was double microcatheter embolization, but the spring coil push rod could not be withdrawn from the microcatheter.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).No patient symptoms or further complications were reported as a result of this even t.Additional information was received that the cause of the push rod resistance was not determined.It was noted that the resistance seemed to occurred at the distal end of the catheter.

• Brand Name: AXIUM PRIME BRPL HLX
• 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: 18519714
• Report Number: 2029214-2024-00109
• Device Sequence Number: 6732407
• Product Code: KRD
• UDI-Device Identifier: 00763000313845
• UDI-Public: 00763000313845
• 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): 01/16/2024

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: 06/17/2026
• Device Model Number: APB-1.5-4-HX-ES
• Device Catalogue Number: APB-1.5-4-HX-ES
• Device Lot Number: 226786484
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/16/2024
• Date Device Manufactured: 06/17/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 72 KG