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

Model Number	REL46
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Hematoma (1884)
Date of Event	07/22/2019
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of 55x70mm abdominal aortic aneurysm.It was reported that as the physician was ballooning the proximal neck with the reliant balloon, the physician felt as though the aorta ¿gave¿ while inflating the balloon.There was no issue noted at this point and final angio showed no issue.However, the patient complained of abdominal discomfort during recovery.A ct scan showed hematoma of the left kidney.The physician decided to bring the patient back into the or to explore the abdomen.There was some blood noted in the abdomen and the physician decided to place a cuff etcf2828c49e across the renal arteries to control bleeding.As per the physician, the cause of the event was due to a fragile aorta.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Additional information received; it was reported the patient expired.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information received reported that the patient expired 8 days after the index procedure.As per the physician, the patient's death was related to the patient's fragile aorta and an error in inflating the reliant balloon too aggressively.The reliant balloon itself was not at fault.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RELIANT BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 8863628
• Report Number: 9612164-2019-03215
• Device Sequence Number: 11451876
• Product Code: DQY
• UDI-Device Identifier: 00763000200947
• UDI-Public: 00763000200947
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K050038
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Device Lot Number: 0009721580
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/08/2019; 09/21/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/04/2019; 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 83 YR