MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR AXIUM PRIME BRPL 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-3.5-6-3D-ES
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2018
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 a report that the physician attempted to detach the coil with the instant detacher but it failed, so they tried to release it by breaking the break indicator but it still would not detach.The doctor then slightly pushed and pulled the delivery pusher several times which allowed the coil to detach and the procedure to complete without issue.This was later described as the part falling into the patient's cavity and being unable to be retrieved.Prior to this two other coils had been placed successfully.The patient was undergoing embolization surgery to treat a 9mm x 5mm aneurysm.There were no related patient symptoms.It was noted that the patient's vessel tortuosity was moderate with no abnormalities.Ancillary devices include an sl-10 catheter.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8028080
• Report Number: 2029214-2018-00901
• Device Sequence Number: 13799531
• Product Code: KRD
• UDI-Device Identifier: 00847536021259
• UDI-Public: 00847536021259
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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: 11/26/2020
• Device Model Number: APB-3.5-6-3D-ES
• Device Catalogue Number: APB-3.5-6-3D-ES
• Device Lot Number: A561203
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 11/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1