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

Model Number	APB-1-3-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received a report that the coil could not be detached.The patient was undergoing surgery for treatment of an amorphous, unruptured aneurysm of the left middle cerebral artery bifurcation with a max diameter of 6mm and a 3mm neck diameter.It was noted the patient's blood flow was normal and vessel tortuosity was minimal.It was reported that the spring coil could not be detached, and the detacher and manual  detachment were tried many times, and then withdrawn from the body.The physician attempted to detach the coil with the instant detacher 3 times and tried with a second detacher 2 times.There were 2 attempts of manual detachment via hypotube.It was noted that there was no issues with the instant detacher.The reported device and any accessory devices were prepared as indicated in the instructions for use (ifu).There were no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Additional information received reported prior to coil non detaachment, no issues were encountered.No pushwire damage was obsereved after removal from patient.
Additional Manufacturer Narrative
H3: product analysis of apb-1-3-hx-es, item:10,lotno:227529016 as found condition- the axium prime coil was returned for analysis within a shipping box; within a sealed plastic biohazard pouch; within a dispenser coil and within an introducer sheath.Visual inspection/damage location details: the actuator interface was found securely attached to the coupler tube and the break indicator was found intact.There were no evidence of detachment attempts at these locations using an instant detacher or by manual method.The axium prime pusher was found bent at ~6.8cm from the proximal end.No damages or irregularities were found with the shield coil.The coin was found still against the lumen stop.The axium prime implant coil was found damaged within the introducer sheath.No damages or irregularities were found with the introducer sheath.Testing/analysis ¿ an in-house instant detacher was used for detachment testing.No difficulty was experienced inserting the pusher into the instant detacher, and the load indicator was not visible when the pusher was fully seated in the instant detacher cap, which is normal.The implant coil was successfully detached on the first attempt without any difficulty.Conclusion - based on the customer report and device analysis, the customer report of "non-detachment" could not be confirmed and the cause could not be determined.The failure could not be replicated as the device detached with no issues on the first attempt using an in-house instant detacher.The instant detacher used in the event was not returned for analysis.Therefore, any contribution of the instant detacher towards the non-detachment and conformance to specification could not be assessed.The pusher was found bent and the implant coil was found damaged; however, these damages did not contribute towards the reported failure.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19079113
• Report Number: 9612164-2024-01704
• Device Sequence Number: 12450674
• Product Code: KRD
• UDI-Device Identifier: 00847536020924
• UDI-Public: 00847536020924
• 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,Followup,Followup
• Report Date (Section B): 06/26/2024

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 Model Number: APB-1-3-HX-ES
• Device Catalogue Number: APB-1-3-HX-ES
• Device Lot Number: 227529016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Supplement Date Received by Manufacturer: 04/11/2024; 05/31/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/05/2024; 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/12/2023
• 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 Sex: Male