MAUDE Adverse Event Report: MEDTRONIC NV AXIUM PRIME BRPL HLX; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-3-8-HX-ES
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during coiling treatment of cerebral aneurysm, this coil had tail outside the aneurysm.It was reported that after framing with a coil of another company, the doctor used the reported coil.The reported coil was inserted without problem.The coil was detached, and the delivery pusher was removed.After a while, the tail of the coil went back to the inside of the microcatheter.The doctor inserted the following coil in that situation and pushed the tail of the reported coil out of the microcatheter, and the following coil was also inserted.It was reported that the physician confirmed through angiography that this coil detached.The pushwire was completely removed from the catheter.There was not any coil still attached to the pushwire.The devices were prepare per ifu.The coil was detached and placed inside the patient (no complications occurred).Reoperation was not required.The surgical time was not extended.No patient injury was reported.Vessel diameter: medium vessel status: no abnormalities.Instant detacher lot number a687510.

• Brand Name: AXIUM PRIME BRPL HLX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC NV; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8326540
• Report Number: 2029214-2019-00110
• Device Sequence Number: 19321360
• Product Code: KRD
• UDI-Device Identifier: 00847536021099
• UDI-Public: 00847536021099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K081465
• 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): 02/11/2019

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: 07/10/2021
• Device Model Number: APB-3-8-HX-ES
• Device Catalogue Number: APB-3-8-HX-ES
• Device Lot Number: A673913
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1