MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Model Number ESBF2814C103E

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Necrosis (1971); Insufficient Information (4580)

Event Date 01/29/2022

Event Type  Death  

Manufacturer Narrative

Other relevant device(s) are: product id: etlw1620c124e, serial/lot #: (b)(4), ubd: 05-mar-2022, udi#: (b)(4).Product id: etlw1620c156e, serial/lot #: (b)(4), ubd: 29-oct-2023, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant iis bifurcated stent graft system was implanted during an endovascular procedure for the treatment of an abdominal aortic aneurysm. it was reported on the evening of implant the patient was reportedly doing great and was checked on by the physician.It was reported some time the following day, the patients blood pressure suddenly dropped to 60.The patient was brought to the operating room where the physician identified that the patients bowel had become necrotic/ischemic and later the patient expired.The physician reported when examining the aorta that the graft had not covered either renal artery or the patent sma.It was said though that during the index procedure, the physician said when ballooning the proximal part of the graft it felt that something gave way at the time.The physician suspected possibly a piece of calcium broke off and covered the patients sma causing a flap in front of the sma, in which the physician attributed to the death of the patients bowel and ultimately the patients heart failing.It was reported the patient also recently underwent spinal surgery also.As per the physician the cause of the event cannot be determined.No additional clinical sequelae was provided and the patient has expired.

Manufacturer Narrative

B5; additional information received ; it was reported that it was a reliant balloon used during the index procedure that may have dislodged the piece of calcium that covered the patients sma.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: ENDURANT IIS BIFURCATED STENT GRAFT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• 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: 13451495
• MDR Text Key: 285052252
• Report Number: 9612164-2022-00481
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: 00643169439979
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100021
• 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,Followup
• Report Date: 03/09/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2023
• Device Model Number: ESBF2814C103E
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2022
• Initial Date FDA Received: 02/04/2022
• Supplement Dates Manufacturer Received: 02/14/2022
• Supplement Dates FDA Received: 03/09/2022
• Date Device Manufactured: 12/02/2021
• 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): Death
• Patient Age: 61 YR
• Patient Sex: Male