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

Model Number	APB-3-8-3D-ES
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
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 information that during coiling treatment of unruptured, saccular posterior communicating artery aneurysm, this coil stretched during the procedure and detached itself inside the aneurysm.It was reported that the coil stretch occurred in case, maybe not a coil stretched itself, just strand resist wire was stretched, but it was detached later.The coil was implanted at the intended location.The procedure completed successfully.There were not any patient symptoms or complications associated with this event.No images available for review.The patient¿s blood flow was normal.The vessel was normal tortuous.No patient injury was reported.Reported device and any accessory devices were prepared as indicated in the ifu.There was not any friction or difficulty during testing or delivery.Yes, the continuous flush was administered during the procedure.The physician did not reposition the coil during the procedure.Any access or associated devices used - asked but will not be made available (legal/confidential reason) only coil's delivery wire will be returned.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The device was returned for evaluation and the clinical observation was confirmed.As received, the implant coil was found to be detached from the pushwire and knotted.Additionally, the implant coil was found stretched within the introducer sheath with a broken polypropylene filament.The tack weld replacement (twr) crimps and the pushwire distal to the break indicator (via hypotube) were found to be intact.The pushwire was found to be bent at several locations from the proximal end.It appeared that the implant coil broken loose from the coil shell at the coil shell weld.All other subassemblies appeared to be normal and no other anomalies were observed.Based on the axium prime coil analysis and on the event description, the cause for the event could not be determined.Rotation of the pushwire, difficulty during delivery and difficulty positioning can lead to these failure modes.All coils are 100% inspected for damages and irregularities during manufacture.The axium prime coil instructions for use (ifu) issues the following: warning: ¿do not rotate the implant delivery pusher during or after delivery of the coil into the aneurysm.Rotating the delivery pusher during or after coil delivery into the aneurysm may result in a stretched coil or premature detachment of the coil from the implant delivery pusher, which could result in coil migration.¿ if information is provided in the future, a supplemental report will be issued.

• Brand Name: AXIUM PRIME BARE 3D
• Common Device Name: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): MEDTRONIC; 9775 toledo way; irvine,ca
• MDR Report Key: 7622673
• Report Number: 2029214-2018-00573
• Device Sequence Number: 11186269
• Product Code: KRD
• UDI-Device Identifier: 00847536021242
• UDI-Public: 00847536021242
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K151447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/24/2018

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: 08/23/2020
• Device Model Number: APB-3-8-3D-ES
• Device Catalogue Number: APB-3-8-3D-ES
• Device Lot Number: A513501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2018
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 09/18/2018
• Initial Report FDA Received Date: 06/20/2018
• Supplement Report FDA Received Date: 06/20/2018; 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1