MAUDE Adverse Event Report: COVIDIEN (IRVINE) AXIUM PRIME BRPL 3D; DEVICE, EMBOLIZATION, VASCULAR

Model Number	APB-4-12-3D-SS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The axium coil has not been returned for evaluation; product analysis cannot be performed.The device was not returned, therefore the reported event could not be confirmed.The cause of the event cannot be conclusively determined from the provided information.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received report of axium premature detachment.The patient was undergoing treatment of a ruptured, saccular aneurysm at the basal artery tip.Vessel tortuosity was described as normal.The devices were prepared as indicated in the ifu.A continuous flush was used during the procedure.It was reported that during the procedure, the axium coil accidentally released during advancement through the catheter.No attempts had been made to detach the coil.The catheter and coil were removed from the patient together.A new coil was used to complete the procedure.There were no reports of patient injury in association with this event.
Additional Manufacturer Narrative
The axium pushwire was returned for evaluation without the axium prime coil and the catheter were not returned.The reason for not returning was not provided.Although the tack weld replacement (twr) crimps were found to be broken, the pushwire was found to be intact distal to the break indicator at the manual detachment location.No bend was found on the pushwire.Under the microscope, the coin was not found against the lumen stop, the coil shield was present, and the implant coil was found to be detached.The coin was measured in 3 locations and was found to be within specifications.The inner diameter of the lumen stop and the inner diameter of the retainer ring were found to be visually acceptable.The lumen stop inner diameter (id) was measured and found to be within specification.The retainer ring inner diameter (id) was measured and found to be within specification.All other subassemblies appeared to be normal and no other anomalies were observed.Based on the analysis findings and the reported event details, the customer report of "pre-mature detachment" was confirmed as implant coil was found to be detached from the pushwire.The implant coil and the catheter were not returned; therefore, any contributing factors from the implant coil and catheter could not be assessed.The broken tack weld replacement (twr) crimps likely were broken during a mechanical detachment attempt; which led to the coil detachment.However, the customer reported that no attempts had been made to detach the coil.No bend was found on the pushwire.In addition, there was reportedly no friction during advancement.All parts of the returned pushwire which could affect the detachment were found to be within specifications.Per our instruction for use: "if the coil does not move with a one-to-one motion, or repositioning is difficult, the coil has been s tretched and could possibly break.Gently remove and discard both the catheter and coil." medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects" or has "malfunctioned".These words are included in the fda 3500a form and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.Medtronic objects to the use of these words and others like it because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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): COVIDIEN (IRVINE); 9775 toledo way; irvine CA 92618
• MDR Report Key: 8085657
• Report Number: 2029214-2018-00957
• Device Sequence Number: 11205141
• Product Code: KRD
• UDI-Device Identifier: 00847536008120
• UDI-Public: 00847536008120
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 02/26/2021
• Device Model Number: APB-4-12-3D-SS
• Device Lot Number: A604316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 10/31/2018
• Supplement Date Received by Manufacturer: 02/12/2019
• Initial Report FDA Received Date: 11/19/2018
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR