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

Catalog Number RMT231214J

Device Problems Sticking (1597); Difficult to Advance (2920)

Patient Problems Vomiting (2144); Rupture (2208)

Event Date 12/17/2014

Event Type  Injury  

Event Description

On an unknown date in 2013, the patient underwent an emergent open surgery to repair a ruptured abdominal aortic aneurysm.It was reported that the patient's proximal half of the infrarenal abdominal aorta was replaced with a straight vascular graft.On an unknown date in (b)(6) 2014, the patient vomited blood and was emergently transferred to the institution.It was reported that upon arrival the patient's vital signs were stable.On (b)(6) 2014, ct images showed rupture of a pseudoaneurysm distal to the vascular graft.As the patient vomited blood earlier, the physician diagnosed this as aorto-duodenal fistula located at the distal anastomosis site of the graft.On (b)(6) 2014, the patient underwent an endovascular procedure using a gore® excluder® aaa endoprosthesis featuring c3® delivery system to repair the rupture and aorto-duodenal fistula.It was reported that at pre-operative angiography contrast did not flow into the duodenum.The bilateral internal iliac arteries were embolized prior to the procedure.It was reported that a gore® dryseal sheath with hydrophilic coating (dsl1828j/unknown) was stuck at the distal edge of the vascular graft and did not advance into the graft.The trunk-ipsilateral leg component (rmt231214j/12826882) was then advanced outside of the sheath, and leading end of the delivery catheter was stuck at the distal edge of the graft too.The physician pushed up the delivery catheter, and this caused the aorta and fistula to receive more damage and become worsened.The patient vomited blood and the vital signs were worsened.The abdominal aorta was occluded with a balloon for hemostasis.The trunk-ipsilateral leg component was then fully deployed around the level of distal anastomosis site of the vascular graft (distal to the intended position), and two aortic extender components (pxa230300j/unknown, pxa230300j/unknown) were implanted within the vascular graft to extend the proximal neck.It was reported that as the trunk-ipsilateral leg component was deployed too distal to cannulate the contralateral gate, the procedure was converted to aorto-uni-iliac.Another aortic extender components (pxa230300j/unknown) was implanted to cover the bifurcation of the trunk-ipsilateral leg component.The final angiography showed no issues, and left femoral-right femoral bypass surgery was performed.The patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Manufacturer Narrative

Corrected event description.

Event Description

On an unknown date in 2013, the patient underwent an emergent open surgery to repair a ruptured abdominal aortic aneurysm.It was reported that the patient's proximal half of the infrarenal abdominal aorta was replaced with a straight vascular graft.On an unknown date in (b)(6) 2014, the patient vomited blood and was emergently transferred to the institution.It was reported that upon arrival the patient's vital signs were stable.On (b)(6) 2014, ct images showed rupture of a pseudoaneurysm distal to the vascular graft.As the patient vomited blood earlier, the physician diagnosed this as aorto-duodenal fistula located at the distal anastomosis site of the graft.On (b)(6) 2014, the patient underwent an endovascular procedure using a gore excluder aaa endoprosthesis featuring c3 delivery system to repair the rupture and aorto-duodenal fistula.It was reported that at pre-operative angiography contrast did not flow into the duodenum.The bilateral internal iliac arteries were embolized prior to the procedure.It was reported that a gore dryseal sheath with hydrophilic coating (dsl1828j/unknown) was stuck at the distal edge of the vascular graft and did not advance into the graft.The trunk-ipsilateral leg component ((b)(4)/12826882) was then advanced outside of the sheath, and leading end of the delivery catheter was stuck at the distal edge of the graft too.The physician pushed up the delivery catheter, and this caused the aorta and fistula to receive more damage and become worsened.The patient vomited blood and the vital signs were worsened.The abdominal aorta was occluded with a balloon for hemostasis.The trunk-ipsilateral leg component was then fully deployed around the level of distal anastomosis site of the vascular graft (distal to the intended position), and two aortic extender components ((b)(4)/unknown, (b)(4)/unknown) were implanted within the vascular graft to extend the proximal neck.It was reported that as the trunk-ipsilateral leg component was deployed too distal to cannulate the contralateral gate, the procedure was converted to aorto-uni-iliac.Another aortic extender components ((b)(4)/unknown) was implanted to cover the bifurcation of the trunk-ipsilateral leg component.The final angiography showed no issues, and left femoral-right femoral bypass surgery was performed.The patient tolerated the procedure.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86001
• Manufacturer Contact: miyuki kurihara ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4395206
• MDR Text Key: 5431933
• Report Number: 2017233-2015-00008
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/09/2015

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Catalogue Number: RMT231214J
• Device Lot Number: 12826882
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2014
• 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; Other
• Patient Age: 82 YR