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

Model Number	RLT261414
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2022, a patient was treated with a gore® excluder® aaa endoprosthesis.Around six weeks later, the patient presented with ischemia in the legs.Upon examination, it was found that the endoprosthesis had folded proximally.The patient was treated with a thrombectomy and two bare metal stents were implanted to support the endoprosthesis.The patient tolerated the procedure.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
H6: 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 occlusion of device or native vessel.
Additional Manufacturer Narrative
The imaging evaluation performed by a clinical imaging specialist showed the following: two time-points available for evaluation: pre-implantation cta dated (b)(6) 2022 and an intra-operative angiogram dated (b)(6) 2022.The pre-implantation cta shows: proximal neck diameters appear to range from 19.3mm ¿ 19.9mm.There appears to be a dissection in the lci ~193mm distal to the left renal artery.The lci dissection extends into the right external iliac artery.The length of the dissection appears to be ~10-11cm.The intra-operative angiogram dated 2/10/2022 appears to show: a gore® excluder® endoprosthesis is implanted in the abdominal aorta, distal to the left renal artery.There also appears to be a gore® excluder® iliac branch endoprosthesis implanted in the lci.Contrast cannot be identified outside the proximal end of the device, on the projection provided.Cannot confirm a compressed or infolded proximal device with available imaging.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.
Additional Manufacturer Narrative
A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The imaging evaluation performed by a clinical imaging specialist showed the following: ¿ two time-points available for evaluation: pre-implantation cta dated (b)(6) 2022 and an intra-operative angiogram dated (b)(6) 2022.¿ the pre-implantation cta shows: o proximal neck diameters appear to range from 19.3mm ¿ 19.9mm.O there appears to be a dissection in the lci ~193mm distal to the left renal artery.O the lci dissection extends into the left external iliac artery.The length of the dissection appears to be ~10-11cm.¿ the intra-operative angiogram dated (b)(6)2022 appears to show: o a gore® excluder® endoprosthesis is implanted in the abdominal aorta, distal to the left renal artery.There also appears to be a gore® excluder® iliac branch endoprosthesis implanted in the lci.O contrast cannot be identified outside the proximal end of the device, on the projection provided.Cannot confirm a compressed or infolded proximal device with available imaging.¿ post-implantation cta images dated (b)(6)2022 appear to show: o there is contrast outside the proximal trunk of the previously implanted device.O cta reconstruction images show the proximal trunk is compressed.This finding is confirmed on the axial imaging.O the ipsilateral limb on the patient¿s right side appears to be occluded.Contrast is visualized just proximal to the distal end of the device in the rci.O the contralateral limb on the patient¿s left side appears to be occluded.Contrast is visualized within the ibe device trunk in the distal lci and distally.¿ intra-operative angiogram dated (b)(6)2022 appears to show: o there appears to be ballooning within each device limb extending to the proximal previously implanted device.O cannot confirm 2 stents have been deployed within the previously implanted devices with image quality on the angiogram.However, final contrast image appears to show patency throughout the implanted devices.¿ post-implantation cta dated (b)(6) 2022 appears to show: o contrast outside the implanted devices appears to be resolved.O recontruction images appear to show patency throughout the implanted devices.O images confirm the presence of 2 added stents at the level of the proximal device extending distally into the ipsilateral and contralateral limbs.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.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 occlusion of device or native vessel.The ifu also recommends that a 23 mm endoprosthesis be implanted in a 19-21 mm vessel while a 26 mm endoprosthesis is indicated for a 22-23 mm vessel.
Event or Problem Description
It was reported that on (b)(6) 2022, a patient was treated with a gore® excluder® aaa endoprosthesis (implant #1).Around six weeks later, the patient reportedly presented with ischemia in the legs.Upon examination, it was reportedly found that the endoprosthesis had folded proximally.The patient was reportedly treated with a thrombectomy and two bare metal stents were implanted to support the endoprosthesis (revision #1).The patient reportedly tolerated the procedure.The following information was obtained from the medical records: procedure: endovascular exclusion of the aneurysm by implantation of a stent-graft prosthesis on (b)(6) 2022.Implants: #1 gore® excluder® aaa endoprosthesis, plc271200/(b)(6); #2 gore® excluder® iliac branch endoprosthesis, hgb161407/(b)(6); #3 gore® excluder® iliac branch endoprosthesis, ceb231410/(b)(6); #4 gore® excluder® aaa endoprosthesis, rlt261414/(b)(6); #5 gore® excluder® aaa endoprosthesis, plc161000/(b)(6).Reintervention: on (b)(6) 2022, the patient underwent the following procedure: thrombectomy of aortic and iliac stent-grafts on both sides, and of the left external iliac artery, pta [percutaneous transluminal angioplasty] of the right aortic stent-graft using a 9x80 mm pta balloon, implantation of a 10x60mm balloon-expandable stent into each aortic stent-graft using the kissing stent technique, limited tea [thromboendarterectomy] and suturing of both external iliac arteries, and angiography.No evidence that explant of the devices occurred.Devices remain implanted.

• 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: 14251102
• Report Number: 3007284313-2022-01883
• Device Sequence Number: 11846740
• Product Code: MIH
• UDI-Device Identifier: 00733132622450
• UDI-Public: 00733132622450
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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,Followup
• Report Date (Section B): 10/11/2024

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: 06/17/2024
• Device Model Number: RLT261414
• Device Catalogue Number: RLT261414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 10/17/2022; 11/24/2022; 10/10/2024
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 10/17/2022; 11/28/2022; 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 88 KG