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

Model Number	APB-1.5-3-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned; the reported event could not be confirmed.The cause of the event could not be conclusively determined from the reported information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report that the axium coil failed to detach via the manual method.Apb-1.5-3-hx-es could not be detached, after it completely entered the aneurysm.An instant detacher was not used.5 manual detachment attempts were made but all were unsuccessful.Images have been provided.The patient was treated with qc-1.5-2-helix and apb-1.5-1-hx-es and they were used successfully.The patient was being treated for a ruptured, saccular, cavernous sinus artery.The max diameter was 2.5 mm and the neck was 2 mm.The blood flow and vessel anatomy were booth normal.No patient injury occurred.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9976014
• Report Number: 2029214-2020-00371
• Device Sequence Number: 14015217
• Product Code: KRD
• UDI-Device Identifier: 00847536020955
• UDI-Public: 00847536020955
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/19/2020

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-1.5-3-HX-ES
• Device Lot Number: A962595
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR