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

Catalog Number RLT281212

Device Problems Human-Device Interface Problem (2949); Insufficient Information (3190)

Patient Problem Rupture (2208)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4).Further information and images were requested.

Event Description

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.

Manufacturer Narrative

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.

Event Description

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.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7515937
• MDR Text Key: 108349694
• Report Number: 3007284313-2018-00156
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Catalogue Number: RLT281212
• Device Lot Number: 17787609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2018
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR