W.L. GORE & ASSOCIATES GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number RLT281212 |
Device Problems
Human-Device Interface Problem (2949); Insufficient Information (3190)
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Patient Problem
Rupture (2208)
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Event Date 04/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).Further information and images were requested.
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Event Description
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On (b)(6) 2018, the patient underwent endovascular procedure using gore® excluder® endoprostheses.It was reported that a gore® excluder® aaa endoprosthesis featuring c3® delivery system (rlt281212/17787609) was advanced and deployed as per gore® excluder® aaa endoprosthesis instructions for use (ifu).Upon ballooning the proximal end, the patients¿ blood pressure dropped due to a rupture in the patient¿s aorta below the left renal artery.Aortic extender components were immediately placed, which did not seal the rupture.The physician gained access from the patients arm to place stents into the renal arteries and sma.The additional pla360400/1551830 device was placed over the renal arteries.A contralateral leg component (plc14100/17218283) was placed to extend ipsilateral side of excluder into right common and plc161200/17674201 was placed to seal in left common.A rlt281212/17590259 was advanced and landed at the celiac artery.A plc16100/17576008 was placed in the ipsilateral side to reinforce and a plc161200/17674205 was placed on the contralateral side.These limbs sealed into the previously placed excluder limbs.Reportedly, the patient continued to have a leak, but was stable and will have another scan.Further information will be provided.It was reported that all devices prepared as per gore® excluder® aaa endoprosthesis instructions for use (ifu).Anatomically, the infrarenal neck was calcified and contained thrombus.Rupture caused by ballooning and vessel integrity.
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Manufacturer Narrative
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Additional information was requested but was not available.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 bleeding.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), key anatomic elements that may affect successful exclusion of the aneurysm include significant thrombus and / or calcium at the arterial implantation sites, specifically the proximal aortic neck and distal iliac artery interface.Additional considerations for patient selection include but are not limited to patient¿s anatomical suitability for endovascular repair.
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Event Description
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Upon ballooning the proximal end by a reliant balloon (medtronic), the patient's blood pressure dropped due to a rupture in the patient¿s aorta below the left renal artery.Aortic extender components were immediately placed, which did not seal the rupture.
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Search Alerts/Recalls
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