MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problems Microbial Contamination of Device (2303); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Fistula (1862); Inflammation (1932); Sepsis (2067)

Event Date 12/21/2023

Event Type  Injury  

Event Description

The following literature article has been received: "surgical explantation of a fenestrated endovascular abdominal aortic aneurysm repair device complicated by aorto-enteric fistula", published online december 09, 2020.Article citation: caradu c, vosgin-dinclaux v, lakhlifi e, dubuisson v, ducasse e, bérard x.Surgical explantation of a fenestrated endovascular abdominal aortic aneurysm repair device complicated by aorto-enteric fistula.Ejves vasc forum.2020 dec 19;50:12-18.Doi: 10.1016/j.Ejvsvf.2020.12.020.Pmid: 33937899; pmcid: pmc8077032.Background: alarming outcomes have been reported following infected endovascular aortic aneurysm repair (evar) device explantation.Infected fenestrated evar (fevar) exposes patients to even worse procedural risks.As reported in the latest european society for vascular surgery (esvs) guidelines, treatment goals are to eradicate the infectious source by ¿complete excision of all graft material and infected tissue¿.Infected fenestrated evar (fevar) exposes patients to even worse procedural risks, as reported in this case of complete fevar excision for saef.Report: a 67 year old man presented with impaired general condition, and abdominal and lower back pain on day one following his latest endovascular procedure.One year before, he had undergone fevar with a zenith fenestrated graft (cook medical, bloomington, in, usa), including a superior mesenteric artery (sma) scallop, fenestration and bridging stent for each renal artery, and a bifurcated endograft to treat a proximal pseudo-aneurysm following an aorto-iliac dacron bypass implanted 12 years previously for an infrarenal abdominal aortic aneurysm.Multiple distal revision procedures were subsequently required.One of these revisions occurred a year prior to this event was a treatment for a proximal pseudo-aneurysm treated by a bifurcated c3 gore excluder endograft [gore® excluder® bifurcated endoprosthesis and gore® c3® delivery system].Computed tomography angiography (cta) revealed a collection around the aortic graft bifurcation, and positron emission tomography (pet) revealed increased f-fluorodeoxyglucose (fdg) uptake at this level, confirmed by labelled wbc scintigraphy.The patient was noted to have a graft infection and the follow procedure took place: complete excision of endografts, bridging stents, and ancient dacron graft left thoracorenal bypass in situ reconstruction with bifurcated antimicrobial graft implanted below sma, re-implantation of right renal artery to main body graft (thoracophrenolumbotomy, ligature of left hypogastric artery).The graft enteric erosion was located in the aneurysm wall and not near the endograft hooks, and it was a small bowel rather than duodenal fistula.The hospital stay was 30 days, including 20 days in a surgical resuscitation ward.The antibiotic regimen was changed to piperacillin/tazobactam while maintaining linezolid and caspofungin for 13 days and was then switched to sulfamethoxazole/ trimethoprim for a total of six weeks.Eleven months later, the patient was free from re-infection, with normalized renal function.However, at 12 months, he presented with acute occlusion of the left renal artery and a decline in renal function.Conclusion: total explantation of stent grafts with tissue debridement and post-operative antibiotic therapy is the gold standard when dealing with infected evar.As with a type iv taa open repair, fevar device explantation requires additional protective measures to prevent visceral ischemia and kidney impairment.In agreement with the esvs guidelines, such patients should be referred to dedicated vascular centers with expertise in surgical repair, anesthetics, and post-operative intensive care.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: review of the manufacturing and sterilization records could not be performed as a valid lot number was not provided.H3: engineering evaluation could not be performed as the location of device is unknown.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

H6: d15 was submitted not correctly.The final conclusion code should be updated to d14.

Event Description

The following literature article has been received: "surgical explantation of a fenestrated endovascular abdominal aortic aneurysm repair device complicated by aorto-enteric fistula", published online december 09, 2020.Article citation: caradu c, vosgin-dinclaux v, lakhlifi e, dubuisson v, ducasse e, bérard x.Surgical explantation of a fenestrated endovascular abdominal aortic aneurysm repair device complicated by aorto-enteric fistula.Ejves vasc forum.2020 dec 19;50:12-18.Doi: 10.1016/j.Ejvsvf.2020.12.020.Pmid: 33937899; pmcid: pmc8077032.Background: alarming outcomes have been reported following infected endovascular aortic aneurysm repair (evar) device explantation.Infected fenestrated evar (fevar) exposes patients to even worse procedural risks.As reported in the latest european society for vascular surgery (esvs) guidelines, treatment goals are to eradicate the infectious source by ¿complete excision of all graft material and infected tissue¿.Infected fenestrated evar (fevar) exposes patients to even worse procedural risks, as reported in this case of complete fevar excision for safe.Report: a 67 year old man presented with impaired general condition, and abdominal and lower back pain on day one following his latest endovascular procedure.One year before, he had undergone fevar with a zenith fenestrated graft (cook medical, bloomington, in, usa), including a superior mesenteric artery (sma) scallop, fenestration and bridging stent for each renal artery, and a bifurcated endograft to treat a proximal pseudo-aneurysm following an aorto-iliac dacron bypass implanted 12 years previously for an infrarenal abdominal aortic aneurysm.Multiple distal revision procedures were subsequently required.One of these revisions occurred a year prior to this event was a treatment for a proximal pseudo-aneurysm treated by a bifurcated c3 gore excluder endograft [gore® excluder® bifurcated endoprosthesis and gore® c3® delivery system].Computed tomography angiography (cta) revealed a collection around the aortic graft bifurcation, and positron emission tomography (pet) revealed increased f-fluorodeoxyglucose (fdg) uptake at this level, confirmed by labelled wbc scintigraphy.The patient was noted to have a graft infection and the follow procedure took place: complete excision of endografts, bridging stents, and ancient dacron graft left thoracorenal bypass in situ reconstruction with bifurcated antimicrobial graft implanted below sma, re-implantation of right renal artery to main body graft (thoracophrenolumbotomy, ligature of left hypogastric artery).The graft enteric erosion was located in the aneurysm wall and not near the endograft hooks, and it was a small bowel rather than duodenal fistula.The hospital stay was 30 days, including 20 days in a surgical resuscitation ward.The antibiotic regimen was changed to piperacillin/tazobactam while maintaining linezolid and caspofungin for 13 days and was then switched to sulfamethoxazole/ trimethoprim for a total of six weeks.Eleven months later, the patient was free from re-infection, with normalized renal function.However, at 12 months, he presented with acute occlusion of the left renal artery and a decline in renal function.Conclusion: total explantation of stent grafts with tissue debridement and post-operative antibiotic therapy is the gold standard when dealing with infected evar.As with a type iv taa open repair, fevar device explantation requires additional protective measures to prevent visceral ischemia and kidney impairment.In agreement with the esvs guidelines, such patients should be referred to dedicated vascular centers with expertise in surgical repair, anesthetics, and post-operative intensive care.

Manufacturer Narrative

The author has been asked to provide additional information.No response or additional information has been received.No review of manufacturing records could be performed as no device specific information has been shared.No engineering evaluation could be performed as no device was returned.No sample results of the gore device confirming stent graft infection were shared with gore.Alleged infection of the gore device could neither be confirmed nor disproved during the investigation.Based on the review of the literature and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of the reported aorto-enteric fistula, subsequently leading to the reported stent graft infection, and assign a root cause.The available information reported in the literature does not reasonably suggest a potential malfunction with respect to device performance or a product packaging issue has occurred.The reported stent graft infection represents a known complication or adverse event that can occur when using stent-graft endovascular devices and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen and patient-related risk factors.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to infection.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: katharina herkt ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18146956
• MDR Text Key: 328225034
• Report Number: 3007284313-2023-02887
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/29/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 11/07/2023; 11/07/2023
• Supplement Dates FDA Received: 01/25/2024; 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: ZENITH FENESTRATED GRAFT (COOK MEDICAL).
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male