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

Model Number	QC-22-50-3D
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The coil has not been returned for evaluation; product analysis could not be performed.The device was not returned; the reported event could not be confirmed and an event cause could not be conclusively determined from the provided information.Mdrs related to this event: 2029214-2019-00245, 2029214-2019-00246.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the physician could not detach the implant coil with the instant detacher after the coil was inserted into the aneurysm.Another instant detacher (with different lot) was used and the implant coil still could not be detached.There was also an attempt to detach the coil using the manual method (breaking of the hypotube, an alternative detachment method presented in the instructions for use) but the coil still did not detach.In the end, prime coils were used and they were able to be successfully detached.No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of cerebral aneurysm measuring 24mm.The patient¿s vasculature was medium in tortuosity.Ancillary devices: prime coils.

• Brand Name: AXIUM 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8454532
• Report Number: 2029214-2019-00246
• Device Sequence Number: 1147702
• Product Code: KRD
• UDI-Device Identifier: 00836462010536
• UDI-Public: 00836462010536
• 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): 03/26/2019

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: 12/18/2021
• Device Model Number: QC-22-50-3D
• Device Catalogue Number: QC-22-50-3D
• Device Lot Number: A757571
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1