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

Model Number	APB-1.5-4-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil has not been returned for evaluation; product analysis cannot be performed.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.Mdrs related to this event: 2029214-2019-00314, 2029214-2019-00315, 2029214-2019-00316.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that three implant coils had detachment failures when using the instant detacher (id-1).The axium 1x3 and 2.5x6 were detached smoothly upon using the manual method (breaking of the hypotube, an alternative detachment method presented in the instructions for use); however, the axium 1.5x4 could not be detached by the manual method.The coil was then pulled back into the microcatheter for removal and suddenly detached inside the microcatheter in the process.The pushwire was removed from the microcatheter and a 0.001 guidewire was inserted into the same microcatheter to push the detached coil into the aneurysm as intended.No patient injury was reported as a result of the procedure.The patient was undergoing embolization treatment for a 7mm aneurysm in vasculature that was medium in tortuosity.It was noted that the coils were performed with flushing to air flush and there was no resistance at the time of insertion; however, the break indicator cut worse than before and did not feel right during the process of detachment using the manual method.

• Brand Name: AXIUM PRIME BARE PL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8490181
• Report Number: 2029214-2019-00314
• Device Sequence Number: 19200297
• Product Code: KRD
• UDI-Device Identifier: 00847536021167
• UDI-Public: 00847536021167
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/07/2019

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: 10/12/2020
• Device Model Number: APB-1.5-4-3D-ES
• Device Lot Number: A538728
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1