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

Model Number REL46

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Date 11/24/2021

Event Type  Death  

Manufacturer Narrative

Film evaluation summary: the reported rupture and endoleak could not be assessed on the films provided; therefore the cause of the event could not be determined.Procedural angiogram showing deployment of the device, post-implant ballooning and the subsequent rupture were not received for a thorough analysis of the event.It is possible that bifurcate oversizing from implanting a 28mm diameter bifurcate into a proximal neck flow of ~19-25mm diameter, may have contributed to the event but this could not be confirmed and the exact positioning of the first bifurcate implanted is unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant ii stent graft system was implanted during an endovascular procedure for the treatment of a 55mm abdominal aortic aneurysm.It was reported during the index procedure in a post implant angioplasty the patients aorta ruptured.An endurant 36x16x145 was immediately placed below main renal arteries and about 3.5 cm's above the previously placed main body graft (28x16x103) which was placed low to save two accessory renal arteries.The contra limb was cannulated and an additional contra limb placed to exclude an endoleak.It appeared that the endoleak was resolved however, the blood pressure did not get back to normal.A 28x49 aortic cuff was extended proximal and the endoleak was resolved.It appeared the renal arteries were mostly covered.The patient was transferred out of the angio suite to icu and expired 5 days post the index procedure.Per the physician the cause of the rupture was due to ballooning (reliant) post dilation.The reliant balloon was noted to be slightly proximal to the stent graft.An endoleak was observed from the rupture proximal to the stent graft.Per the physician the cause of death was due to blood loss.No additional clinical sequalae was provided and the patient has expired.

• Brand Name: RELIANT BALLOON
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13557362
• MDR Text Key: 285799641
• Report Number: 9612164-2022-00674
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REL46
• Device Catalogue Number: REL46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other; Death; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 83 KG