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

Model Number UNK-CV-SR-ENDUR-II

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

Patient Problems Abscess (1690); Aneurysm (1708); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994); Sepsis (2067); Obstruction/Occlusion (2422)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Medtronic received the following information obtained from the journal article entitled; gallium-67 scan with single photon emission computed tomography for the evaluation and monitoring of infected abdominal aortic aneurysms: a 10-year case series kwok et al, vascular specialist international pissn 2288-7970 eissn 2288-7989 https://orcid.Org/0000-0001-7628-1687.If information is provided in the future, a supplemental report will be issued.

Event Description

An endurant stent graft was implanted in a patient for the treatment of an impending suspected infected abdominal aortic aneurysm on an unknown date.The patient was also treated with a 2 month course of iv antibiotics followed by a 4-month course of oral antibiotics.It was reported 9 months post the index procedure the patient presented with fever and back pain.Ct showed infective collection around the distal end of the aortic stent-graft.Resolution was confirmed after 1 month treatment.Approximately 2 years post the index procedure cta confirmed an infective collection at the distal end of the stent graft and the patient became febrile and developed sepsis.Antibiotic treatment was commenced.6 months later ct identified an infective/inflammatory lesion anterior to the aortic bifurcation and left common iliac artery, causing tethering of mesenteric vessels and obstruction of the left ureter, with paraspinal extension causing a small paraspinal abscess at l4 and erosion of the l4 and l5 cortices.Additional antibiotics were commenced.Approximately 3 months later recurrence of the rim-enhancing collection adjacent to the l4 vertebral body was seen on ct and further antibiotics were added to the treatment.Subsequent follow-up cts from 3-5 years post the index procedure showed persistent periaortic inflammatory changes with an enlarging aneurysm.The patient opted for long-term oral antibiotic prophylaxis therapy with interval monitoring instead of surgical exploration.The latest gallium-67 spect with contrast ct 7 years post the index procedure showed no disease recurrence.The cause of the adverse events are undetermined.No additional clinical sequelae were reported 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.

Manufacturer Narrative

Additional information received: the physician believes that the reinfection is not considered as device related infection.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.

• Brand Name: ENDURANT II 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: 12907413
• MDR Text Key: 281499482
• Report Number: 9612164-2021-04643
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P100021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2022

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 Model Number: UNK-CV-SR-ENDUR-II
• Device Catalogue Number: UNK-CV-SR-ENDUR-II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/15/2021; 01/12/2022
• Supplement Dates FDA Received: 01/11/2022; 01/27/2022
• 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): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male