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

Model Number	APB-3-6-HX-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Healthcare provider information is not reported based on the country privacy laws.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 failed to detach.The patient was undergoing a coil embolization procedure to treat a subarachnoid hemorrhage related to a ruptured amorphous aneurysm of the left middle cerebral artery (mca).The aneurysm max diameter was 5mm and the neck diameter was 2-3mm.Blood flow was normal.Vessel tortuosity was moderate.It was reported that the coil was prepared according to the instructions for use.The complaint coil was the fourth to be used in the procedure.The physician attempted 4 or 5 times to detach the coil with the instant detacher without success.It was noted there was no problem with the instant detacher.Manual detachment with the hypotube was also attempted once without success.Finally the coil was removed and replaced with a competitor's product to complete the procedure.There was no harm or injury to the patient.

• 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: 12661761
• Report Number: 2029214-2021-01307
• Device Sequence Number: 14511429
• Product Code: KRD
• UDI-Device Identifier: 00847536021082
• UDI-Public: 00847536021082
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 10/19/2021

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: 02/12/2024
• Device Model Number: APB-3-6-HX-ES
• Device Catalogue Number: APB-3-6-HX-ES
• Device Lot Number: 221689774
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1