MAUDE Adverse Event Report: MEDTRONIC IRELAND RELIANT BALLOON; CATHETER, PERCUTANEOUS

Model Number AB46

Device Problem Burst Container or Vessel (1074)

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

Event Date 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii bifurcate stent graft system was implanted in the endovascular treatment of a 49mm abdominal aortic aneurysm.It was reported that the patient had iliac aneurysm and previously had the left internal iliac embolized, the right internal was embolized at time of evar also, the patient experienced some bleeding from diseased femoral also at the start of the procedure, before implanting the endurant system.It was reported that during the index procedure, a reliant balloon was used to assist in the expansion of the stent graft.It was said this balloon burst during ballooning.It was noted the patient¿s iliac arteries were very diseased and the endurant limbs were extended into the external iliac arteries, non-medtronic stent grafts were then implanted distally in the endurant limbs.It was thought the balloon may have snagged on one of these causing the burst balloon.During a post op ct approximately 5 days later, it was reported that infolding was noted at the bifurcation of the stent graft along with a small amount of thrombus.There was no blood flow issue noted.The infolding is at the bifurcation of the main body device, limbs are not involved.As per the physician the cause of the infolding event cannot be determined.The exact cause of the burst balloon is unknown but it could be user related.The burst occurred on the opposite side to where the infolding occurred.No additional clinical sequelae were provided.No treatment is planned currently, flow is good through the graft and the patient will be monitored.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.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 and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee 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 regulatory reporting.Medtronic objects to the use of these words and others like them 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: RELIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 10424534
• MDR Text Key: 204532451
• Report Number: 9612164-2020-03038
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2022
• Device Model Number: AB46
• Device Catalogue Number: AB46
• Device Lot Number: 0010173276
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Weight: 93