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

Catalog Number	RLT281412
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Sepsis (2067)
Date of Event	02/01/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3; implanted devices are being returned to the manufacturer for evaluation.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 or Problem Description
It was reported that a patient treated with an unknown gore® device presented with an infection.The implanted devices were explanted.Additional information has been requested.
Additional Manufacturer Narrative
D10: gore® excluder® aaa endoprosthesis - stent graft contralateral leg, plc161000 - sn (b)(6); gore® excluder® aaa endoprosthesis - stent graft contralateral leg, plc141400 - sn (b)(6); gore® excluder® aaa endoprosthesis - stent graft contralateral leg, plc121400 - sn (b)(6).
Event or Problem Description
It was reported that on (b)(6) 2021, a patient presenting with severe leg claudication, a penetrating aortic ulcer and aortic dilation evident was treated for an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis.On an unknown date in 2022, the patient's left pacemaker was infected.The infected device and a new pacemaker was implanted on the right side.In (b)(6) 2024, the patient presented with general fatigue, fever, lower back pain, iron deficiency anemia and negative blood cultures.Computed tomography imaging (ct) showed continued exclusion of the aneurysm and no evidence of an endoleak.In (b)(6) 2024, a ct thorax, abdomen and pelvis (ct tap) and transthoracic echocardiogram were performed to rule out an occult source of infection.The results were 'unremarkable.' in (b)(6) 2024, the patient continued to present with fatigue and lower back pain.Positron emission tomography (pet) showed thickening of soft tissue surrounding the inverse stent in the abdominal aorta compared to earlier patient imaging.On (b)(6) 2024, the devices were explanted.During the procedure, the patient entered cardiac arrest for 11 minutes.The patient was revived with cardiopulmonary resuscitation and circulation was restored.On (b)(6) 2024, the patient's condition deteriorated while in the intensive care unit.The patient presented with sepsis and a rigid abdomen.On (b)(6) 2024, the patient was treated laparotomy.The recto-sigmoid junction was reportedly ischemic and perforated.The patient expired following the procedure.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release specifications.A review of the sterilization records indicate the lot met all pre-release specifications.The devices and one tissue specimen were returned to w.L.Gore & associates for investigation.Submitted unfixed was a free-floating tissue specimen and gore® excluder® aaa endoprostheses consisting of the following: one trunk-ipsilateral leg endoprosthesis (trunk) with two contralateral leg endoprostheses, one contained within the ipsilateral leg (cl-1), and one contained within the contralateral leg (cl-2) of the trunk.The free-floating tissue specimen was a brown rubbery to firm irregularly shaped tissue coagulum.The specimen conformed to the abluminal surface of the trunk along one of the long aspects of the specimen was presumed to be abluminal aneurysmal sac content.The abluminal surfaces of the system were generally devoid of tissue excepting for scattered plaques of flat brown friable tissue coagulum (consistent with thrombus) beneath the trunk constraint sleeve.Surrounding the proximal scallops and anchors of the trunk were flecks of brown to yellow friable tissue.Histopathological examination of free-floating tissue coagulum (presumptive abluminal aneurysmal sac content) and material from the trunk anchors were performed.The specimen and associated tissue coagulum were received unfixed and placed in formalin on arrival.The tissue examined had moderate autolytic degradation and presumed environmental colonization by branching fungal hyphae on the periphery of the tissues which hindered interpretation.The tissues were consistent with aneurysmal sac thrombus with small numbers of scattered leukocytes and without a marked inflammatory infiltrate or bacterial colonization.Aneurysmal sac infection was not confirmed in the section examined.Following digestion, the system was examined for material disruptions with the aid of a stereomicroscope on a downdraft table at ambient room temperature.The system was examined intact, marked with black and red permanent markers, separated, re-examined, and re-submitted for digestion.No wear related disruptions were identified.Additionally, infection could not be confirmed in the section of the tissue specimen which was examined due to lack of appropriate fixation.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: infection, conversion, and / or death.
Event or Problem Description
It was reported that on (b)(6) 2021, a patient presenting with severe leg claudication, a penetrating aortic ulcer and aortic dilation evident was treated for an abdominal aortic aneurysm with a gore® excluder® aaa endoprosthesis.On an unknown date in 2022, the patient's left pacemaker was infected.The infected device was removed and a new pacemaker was implanted on the right side.In (b)(6) 2024, the patient presented with general fatigue, fever, lower back pain, iron deficiency anemia and negative blood cultures.Computed tomography imaging (ct) showed continued exclusion of the aneurysm and no evidence of an endoleak.In (b)(6) 2024, a ct thorax, abdomen and pelvis (ct tap) and transthoracic echocardiogram were performed to rule out an occult source of infection.The results were 'unremarkable.' in (b)(6) 2024, the patient continued to present with fatigue and lower back pain.Positron emission tomography (pet) showed thickening of soft tissue surrounding the inverse stent in the abdominal aorta compared to earlier patient imaging.On (b)(6) 2024, the devices were explanted.During the procedure, the patient entered cardiac arrest for 11 minutes.The patient was revived with cardiopulmonary resuscitation and circulation was restored.On (b)(6) 2024, the patient's condition deteriorated while in the intensive care unit.The patient presented with sepsis and a rigid abdomen.On (b)(6) 2024, the patient was treated laparotomy.The recto-sigmoid junction was reportedly ischemic and perforated.The patient expired following the procedure.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19228817
• Report Number: 3007284313-2024-03205
• Device Sequence Number: 12483273
• Product Code: MIH
• UDI-Device Identifier: 00733132622528
• UDI-Public: 00733132622528
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/18/2024
• Device Catalogue Number: RLT281412
• Device Lot Number: 23898965
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2024
• Supplement Date Received by Manufacturer: 06/05/2024; 11/13/2024
• Initial Report FDA Received Date: 05/02/2024
• Supplement Report FDA Received Date: 06/05/2024; 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Death; Other
• Patient Sex: Unknown