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

Model Number	APB-3-6-3D-ES
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report that the tip of the echelon microcatheter was found to be damaged after it was shaped.The catheter was replaced to fill the aneurysm.It was then found that the coil push rod was broken.The coil was replaced, and the operation was successfully completed. the patient did not experience any injury or complications.The devices were prepared and flushed according to the instructions for use (ifu).The patient was undergoing treatment for an unruptured, saccular aneurysm located in the posterior communicating artery.The max diameter was 5*8mm, and the neck diameter was 3mm.The patient's blood flow and vessel tortuosity were normal.The access vessel was the femoral artery.
Additional Manufacturer Narrative
Product analysis: as found condition: the echelon-10 micro catheter and axium prime coil were returned for analysis within a shipping box and within a plastic bio-pouch.Visual inspection/damage location details: no damages were found with the echelon-10 catheter hub.No bends or kinks were found with the catheter body.The echelon-10 distal tip was noted preshaped.No damage was found with the echelon-10 distal tip.The echelon-10 micro catheter was found occluded with blood.The axium prime coil was examined.The pusher was found broke at ~82.0cm from the proximal end, retained by the release wire.The release wire was found pulled for ~1.5cm.The pusher was found bent within the introducer sheath at ~45.0cm and ~41.0cm from the distal end of the pusher.The implant coil was found damaged and detached from the pusher within the introducer sheath.The axium prime coil was returned inverted within the introducer sheath with the wavelock at the distal end.Testing/analysis: none.Conclusion: based on the device analysis and reported information, the customer¿s report of ¿pusher kink/damage¿ the report was confirmed.Pusher damage can occur if the device is advanced against resistance.The implant coil can become detached if the pusher becomes damaged.However, the cause for the damage could not be determined as insufficient information was reported.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, 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: 14221158
• Report Number: 2029214-2022-00724
• Device Sequence Number: 5359414
• Product Code: KRD
• UDI-Device Identifier: 00847536031937
• UDI-Public: 00847536031937
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 04/27/2022

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: 08/01/2024
• Device Model Number: APB-3-6-3D-ES
• Device Catalogue Number: APB-3-6-3D-ES
• Device Lot Number: B243287
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/02/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Female