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

Model Number	APB-4-12-3D-SS
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
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 coil would not detach.It was noted that there were 3 attempts made with the instant detacher and 2 attempts made with manual detachment.The patient was undergoing surgery to treat an aneurysm at the mca with a max diameter of 4mm and a neck diameter of 3mm.The devices were prepared as indicated per the ifu.Ancillary devices include an envoy da guide catheter, sl10 microcatheter, and a synchro14 guidewire.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient's vessel tortuosity was normal.The devices were prepared/flushed as indicated per the ifu.It was noted that the physic ian attempted to detach the coil with the instant detacher 3 times but it did not work.However, there was no issue with the instant detacher as it was used to deliver other coils with no problem.There was no resistance during delivery of the coil in the catheter.The patient was ultimately treated very well with no related symptoms.
Additional Manufacturer Narrative
The axium prime implant coil was returned for evaluation inside of a cardboard shipping box and within a sealed plastic pouch.The axium prime pushwire and the instant detacher were not returned.During evaluation, the implant coil was removed from the sealed plastic pouch.The implant coil was found to be damaged and had lost its original shape.The detach element was removed from the implant coil for evaluation.The detachment element was found to be in good shape, and the detachment ball was found to be within specification = 0.0038" +/- 0.00010".The detachment ball was measured to be 0.00374".No other anomalies were found.During analysis of the axium prime implant coil, no evidence was found that would ascribe root cause for the failure of the axium prime implant coil from detaching from its pushwire.If information is provided in the future, a supplemental report will be issued.

• 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: 7798277
• Report Number: 2029214-2018-00734
• Device Sequence Number: 2218059
• Product Code: KRD
• UDI-Device Identifier: 00847536008120
• UDI-Public: 00847536008120
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Followup,Followup
• Report Date (Section B): 11/09/2018

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: 01/11/2021
• Device Model Number: APB-4-12-3D-SS
• Device Catalogue Number: APB-4-12-3D-SS
• Device Lot Number: A580999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2018
• Supplement Date Received by Manufacturer: 09/06/2018; 11/07/2018
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/12/2018; 11/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1