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	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is reported at this time based on analysis results.Product analysis findings: the axium prime coil and was returned for analysis within a shipping box; within a sealed biohazard plastic pouch; within an opened axium prime coil inner pouch and within a dispenser track.The echelon-10 micro catheter used during the event was not returned.The model and lot numbers for the echelon-10 micro catheter were not provided; therefore, compatibility and any contributing factors could not be assessed.The axium prime implant coil was returned within the introducer sheath.The axium pushwire was found to be bent at ~136.8cm and kinked at ~161.4cm from proximal end.The implant coil was found to be broken and not returned.No other anomalies were observed.Based on the device analysis and reported information, the customer¿s report of ¿coil stretch¿ was unable to be confirmed as the implant coil was found to be broken and not returned.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 f rom 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 a report that the axium coil was stretched.A replacement coil was used to complete the procedure.It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event.The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the ophthalmic artery segment with a max diameter of 6 mm and a 4 mm neck diameter.It was noted the patient's blood flow and vessel tortuosity were normal.Additional information received reported there were no other issues noted during the procedure that may have resulted in the damage found.The coil was stretched during delivery.Ancillary device: echelon 10 microcatheter.

• 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
• MDR Report Key: 12292285
• Report Number: 2029214-2021-00989
• Device Sequence Number: 3181546
• Product Code: KRD
• UDI-Device Identifier: 00847536032101
• UDI-Public: 00847536032101
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2021

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: 11/09/2023
• Device Model Number: APB-1-3-HX-ES
• Device Catalogue Number: APB-1-3-HX-ES
• Device Lot Number: B115299
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Initial Report FDA Received Date: 08/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1