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); Insufficient Information (3190); Migration (4003)

Patient Problems Bacterial Infection (1735); Cardiac Arrest (1762); Exsanguination (1841); Fever (1858); Ruptured Aneurysm (4436)

Event Date 01/31/2021

Event Type  Death  

Manufacturer Narrative

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.

Event Description

The following article was reviewed: snoj, z., tomazin, t., salapura, v.And kuhelj, d., 2022.Single centre experience with excluder stent graft graft; 17-year outcome.Radiology and oncology, 56(2), pp.156-163.The article is a single center study of 123 patients presenting with abdominal aortic aneurysms (aaas) treated with gore® excluder® aaa endoprostheses.Patients were treated between october 2002 and june 2008.Patient outcomes were tracked over an average 9.7-year follow-up period which concluded for all patients by january 2021.(b)(6): ninety-five patients died during the follow-up.Eleven patients died due to aaa rupture as coded by the hospital.The other patient deaths are not alleged to be stent graft or procedure-related.The outcomes for the 11 above patients were broken out individually: pt 1 died 51 months after treatment.They were unsuccessfully treated with an aortobifemoral bypass.Pt 2 died 2 days after treatment.Pt 3 died 72.5 months after treatment.They were unsuccessfully resuscitated.Pt 4 died 16.5 months after treatment.They presented with high fever due to spondylodiscitis.Imaging showed signs of stent graft infection.The author revised the coding to discitis.Pt 5 died 50.1 months after treatment.They were treated with proximal extension of the implanted stent grafts.Two months later, they again presented with aaa rupture and died due to exsanguination.Pt 6 died 1.5 months after treatment.They also presented with pneumonia and sepsis.The author revised the coding to pneumonia.Pt 7 died 117.4 months after treatment.They were treated with stent graft extension for unknown reasons 36.7 months after implantation.They died 64.2 months after the most recent ct imaging.Pt 8 died 3.4 months after treatment.They presented with aaa rupture 1.2 months after initial imaging prior to treatment.2.2 months later, they presented with abdominal pain and was unsuccessfully resuscitated.Pt 9 died 18.9 months after treatment.They presented with cardiorespiratory arrest without a history of abdominal pain.The author revised the coding to cardiac arrest.Pt 10 died 2 months after treatment.They presented with sepsis due to septic arthritis.Ct imaging and scintigraphy excluded stent graft infection.The author revised the coding to arthritis.Pt 11 died 21.9 months after treatment.They presented with a type ii endoleak (el) 11.4 months after implantation identified via ct imaging.(b)(6): four patients received transfusions after presenting following hemostatic problems at the vascular access site within the first 24 hours of treatment.Two patients also presented with complications within 24 hours and required reinterventions.One patient presented with occlusion of the posterior tibial artery during inferior mesenteric artery embolization and the other was treated with implantation of a stent graft in the subclavian artery when transaxillary renal stent grafting was not successful.Thirty-seven patients required reinterventions: 14 patients required stent graft extensions (of these, 5 were treated with renal stent grafts due to stenosis of the renal artery), 13 required translumbar sac embolization, 4 required aortobifemoral bypass, 3 required thrombolysis of the iliac limb and 2 required hemicolectomy.Four patients were treated with aortobifemoral bypasses.(b)(6): thirty-five patients presented with els.Of those, 13 patients presented with type i els and 24 patients presented with type ii els.Two patients presented with both type i and type ii els.Aneurysm growth and reintervention (if any) was not disclosed.Thirteen patients presented with post-implantation syndrome.Twelve patients presented with groin hematomas.

Event Description

The following article was reviewed: snoj, z., tomazin, t., salapura, v.And kuhelj, d., 2022.Single centre experience with excluder stent graft graft; 17-year outcome.Radiology and oncology, 56(2), pp.156-163.The article is a single center study of 123 patients presenting with abdominal aortic aneurysms (aaas) treated with gore® excluder® aaa endoprostheses.Patients were treated between october 2002 and june 2008.Patient outcomes were tracked over an average 9.7-year follow-up period which concluded for all patients by january 2021.Ninety-five patients died during the follow-up.Eleven patients died due to aaa rupture as coded by the hospital.The other patient deaths are not alleged to be stent graft or procedure-related.The outcomes for the 11 above patients were broken out individually: pt 1 died 51 months after treatment.They were unsuccessfully treated with an aortobifemoral bypass.Pt 2 died 2 days after treatment.Pt 3 died 72.5 months after treatment.They were unsuccessfully resuscitated.Pt 4 died 16.5 months after treatment.They presented with high fever due to spondylodiscitis.Imaging showed signs of stent graft infection.The author revised the coding to discitis.Pt 5 died 50.1 months after treatment.They were treated with proximal extension of the implanted stent grafts.Two months later, they again presented with aaa rupture and died due to exsanguination.Pt 6 died 1.5 months after treatment.They also presented with pneumonia and sepsis.The author revised the coding to pneumonia.Pt 7 died 117.4 months after treatment.They were treated with stent graft extension for unknown reasons 36.7 months after implantation.They died 64.2 months after the most recent ct imaging.Pt 8 died 3.4 months after treatment.They presented with aaa rupture 1.2 months after initial imaging prior to treatment.2.2 months later, they presented with abdominal pain and was unsuccessfully resuscitated.Pt 9 died 18.9 months after treatment.They presented with cardiorespiratory arrest without a history of abdominal pain.The author revised the coding to cardiac arrest.Pt 10 died 2 months after treatment.They presented with sepsis due to septic arthritis.Ct imaging and scintigraphy excluded stent graft infection.The author revised the coding to arthritis.Pt 11 died 21.9 months after treatment.They presented with a type ii endoleak (el) 11.4 months after implantation identified via ct imaging.

Manufacturer Narrative

Cause investigation and conclusion: several requests were sent to the corresponding author to provide additional information to the incidents reported within the literature.Also patient information, serial number of the devices, dates of procedures and onset dates of the incidents were requested.The requests remained unanswered.A unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Based on the event description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.No potential new or different reasonably foreseeable risks related to the device or its use were identified based on this event.Ongoing risk/benefit assessment affirms risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore will continue to monitor post-market data closely to ensure that the risk assessment remains accurate.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 aneurysm rupture and death, endoleak, fever and/or infection.B5: updated event description.

• 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: kerstin haberländer ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17078270
• MDR Text Key: 316707002
• Report Number: 3007284313-2023-02536
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2023

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: 05/30/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 09/15/2023
• 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
• Patient Outcome(s): Life Threatening; Death; Required Intervention; Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male