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

Model Number	APB-1.5-3-3D-ES
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium prime coil and was returned for analysis.The echelon-10 micro catheter used during the event was not returned.The axium prime coil was returned without the introducer sheath.The axium implant coil pushwire was found to be kinked at 32.5cm from proximal end.The axium implant coil was found to be broken.Based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was unable to be confirmed as the coil was found to be broken.There was no reported issue pushing the axium prime coil out from within the introducer sheath.Therefore, it is possible the axium coil became damaged upon removal from within the introducer sheath; however, the root cause could not be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an axium coil that had resistance and was stretched.The patient was undergoing a coil embolization procedure to treat an unruptured saccular left middle cerebral artery aneurysm.The aneurysm max diameter was 3.2mm and the neck diameter was 2.1mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported that the axium coil was selected as the last coil for the procedure.The coil had resistance during delivery and was found to be stretched and could not be implanted normally.It was noted that the catheter was flushed continuously during the procedure.The physician did not reposition the coil during the procedure.The coil was removed and replaced to complete the procedure successfully.There was no harm or injury to the patient.Additional information received reported clarification that there was no resistance felt during delivery of the coil in the echelon 10 microcatheter and the coil came out of the introducer sheath smoothly.The stretch was observed during the filling process.

• Brand Name: AXIUM PRIME BARE PL 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: 13239671
• Report Number: 2029214-2022-00047
• Device Sequence Number: 14591347
• Product Code: KRD
• UDI-Device Identifier: 00847536021150
• UDI-Public: 00847536021150
• 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): 01/12/2022

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: 05/26/2024
• Device Model Number: APB-1.5-3-3D-ES
• Device Catalogue Number: APB-1.5-3-3D-ES
• Device Lot Number: 222296178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 01/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female