MAUDE Adverse Event Report: MEDTRONIC NEUROVASCULAR AXIUM PRIME BRPL 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-6-15-3D-SS
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2019
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 information that this coil would not detach with an instant detacher or using manual detachment method (breaking hypotube method; an alternative method presented in the instruction for use).The coil detached during removal.The patient underwent coiling treatment for a small unruptured saccular right superior cerebella artery aneurysm, measuring 7mmx3mm.The vessel observed minimal tortuous.It was reported that the physician was using an axium prime 6x15 3d to frame a sca aneurysm with the sca arising from the base of the aneurysm.When he was satisfied with the position of the coil he attempted to detach it with an instant detacher.When he pulled the pusher wire it could be seen that the coil was still attached.He repeated the attempt with the same result.He then broke the hypotube and pulled the release filament in order to manually release the coil.Again the coil came back when the pusher was pulled back.He pushed the coil so that it was at least 5mm outside of the micro catheter but still the coil remained attached.He then made the decision to remove the coil.After approximately 2cm of the coil was removed into the micro catheter it finally detached.He was able to push the proximal end of the coil out with the pusher and the position of the coil was still good.The physician then switched to microvention hyper soft helical coils to finish coiling the aneurysm.There were not any patient symptoms or complications associated with this event.Instant detacher was discarded.

• Brand Name: AXIUM PRIME BRPL 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC NEUROVASCULAR; 9775 toledo way; irvine CA 92618
• MDR Report Key: 8305030
• Report Number: 2029214-2019-00089
• Device Sequence Number: 1063982
• Product Code: KRD
• UDI-Device Identifier: 00847536008274
• UDI-Public: 00847536008274
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K081465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/05/2019

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: 06/21/2021
• Device Model Number: APB-6-15-3D-SS
• Device Catalogue Number: APB-6-15-3D-SS
• Device Lot Number: A665197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR