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

Model Number	QC-5-20-HELIX
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis.All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that the axium implant coil prematurely detached.Prior to the event, an echelon microcatheter was placed in the aneurysm and one axium coil was successfully implanted in the aneurysm.Then the physician introduced the axium qc 3d (reported device) and introduced it halfway and the coil came out into the parent artery.The physician pulled the coil back to reposition it, but resistance was felt and it prematurely detached.Half of the coil was hanging in the parent artery and it was removed with the help of the rebar 27 and solitaire 2 (6 x 30).No patient injury was reported as a result of the event.The patient was undergoing embolization treatment of a ruptured aneurysm measuring 7mm x 3.78mm located in the a-comm.The patient's blood flow was normal.The vasculature was moderate in tortuosity.The pushwire was not bent or broken.The physician only attempted to reposition the coil once.There was no attempt to detach the coil.The physician did not rotate the delivery pusher.A continuous flush was administered.

• Brand Name: AXIUM HELIX
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• MDR Report Key: 9506963
• Report Number: 2029214-2019-01280
• Device Sequence Number: 19292401
• Product Code: KRD
• UDI-Device Identifier: 00836462010154
• UDI-Public: 00836462010154
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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: 10/07/2021
• Device Model Number: QC-5-20-HELIX
• Device Lot Number: A720231
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1