MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT311417J

Device Problems Complete Blockage (1094); No Apparent Adverse Event (3189)

Patient Problems Occlusion (1984); Thrombus (2101); No Consequences Or Impact To Patient (2199)

Event Date 05/08/2020

Event Type  Injury  

Manufacturer Narrative

The plc121400j lot # 21347840 udi:(b)(4) is being reported under mfr report # 3013164176-2020-00072.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 the device or native vessel.

Event Description

The following was reported to gore; on (b)(6) 2020, a patient underwent endovascular treatment of an abdominal aortic dissection using a gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.On (b)(6) 2020, the patient complained the right limb pain.The ct imaged identified that the gore® excluder® aaa endoprostheses implanted in the right limb were occluded with thrombus.The physician attempted to address the occlusion using an endovascular technique, but the guide wire couldn¿t be delivered to the lesion.The physician abandoned the endovascular technique.A femoral ¿ femoral bypass was created.The patient tolerated the procedure.The physician stated that the lumen of endoprosthesis became narrow because the right external iliac artery was tortuous, and this led to the thrombus occlusion of the right limb.

Manufacturer Narrative

Additional information was received indicating the rlt311417j lot # 21363716 was not occluded.Medwatch # 3007284313-2020-00134 was sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch will be retracted.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10084645
• MDR Text Key: 193303744
• Report Number: 3007284313-2020-00134
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2022
• Device Catalogue Number: RLT311417J
• Device Lot Number: 21363716
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR