MAUDE Adverse Event Report: COVIDIEN AXIUM PLATINUM 3D; DETACHABLE COIL

Model Number QC-6-15-3D

Device Problems Break (1069); Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

Treatment of a large aneurysm measuring approximately 18mm x 14mm.On (b)(6) 2014, the patient underwent stent assisted coiling embolization treatment.During the procedure, it was reported that after 10 ed infini (kaneka) coils and 23 axium coils were implanted, the physician inserted another axium coil and attempted to detach it with the instant detacher but it failed to detach.An attempt was made to detach the implant coil with the manual method (breaking of the hypotube, an alternative detachment method presented in the instructions for use), but without success.Upon breaking the hypotube a little bit distal from the break indicator, the release wire also broke.The entire device was removed from the patient.The procedure was completed with the use of 8 more coils (hydrosoft and terumo).The physician commented that the microcatheter was kinked at the origin part of the ic and also that resistance was felt at the beginning of the coiling, but embolization was continued and this might have contributed to the breaking of the release wire.No patient injury was reported as a result of the procedure.

Manufacturer Narrative

The pusher assembly was returned for evaluation with the implant coil still attached.The pusher assembly was found broken into two segments, but the proximal broken segment was discarded.The returned pushwire segment measured approximately 179.5cm in length.The pushwire was found bent at approximately 149cm and 156.25cm from the proximal end and the release wire could not be pulled out of the proximal end due to these bends.The evaluation could not determine the cause of the event; however, the pushwire was found bent in a couple of locations and this may have contributed to the non-detachment and subsequent break of the release wire.Although the cause for the bends in the pushwire and the detachment stick could not be determined, the customer reported that resistance was present during delivery and the possibility of use of a damaged echelon microcatheter during the event.Cross sectional analysis of the break surface of the release wire indicated that the failure was caused by tensile overload.All devices are 100% inspected for damages and irregularities during manufacture.The lot history record of the reported lot number has been reviewed and no issues were noted that would have contributed to this event.

• Brand Name: AXIUM PLATINUM 3D
• Type of Device: DETACHABLE COIL
• Manufacturer (Section D): COVIDIEN; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): (COVIDIEN) IRVINE; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: 9775 toledo way; irvine, CA 92618 ; 9496801558
• MDR Report Key: 4303439
• MDR Text Key: 5269353
• Report Number: 2029214-2014-00711
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2016
• Device Model Number: QC-6-15-3D
• Device Catalogue Number: QC-6-15-3D
• Device Lot Number: 9756123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2014
• Initial Date FDA Received: 12/08/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1