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

Device Problems Partial Blockage (1065); Collapse (1099)

Patient Problems Ischemia (1942); Occlusion (1984)

Event Date 11/01/2005

Event Type  Injury  

Manufacturer Narrative

Since no exact date of the implantation was provided and only the month and year were mentioned in the article, the (b)(6) 2004 was as the implant date.Date of event: since the article mentions that the patient presented ¿precisely 1 year after the stent graft implantation¿ with the aortic dissection, (b)(6) 2005 was used as the date of event.

Event Description

Based on the review of the article, the following updated event description was created: ¿the patient with a history of hypertension underwent uncomplicated implantation of gore® excluder® aaa endoprostheses in (b)(6) 2004 after an ultrasound examination had revealed a 4.5 cm infrarenal aortic aneurysm.Precisely 1 year after the stent graft implantation, the patient suddenly experienced a tearing pain across the anterior and posterior thorax, soon followed by numbness and paresis of the lower limbs.Upon readmission to our department, the patient presented with pale and cold lower extremities and weaker femoral pulses than on prior examinations.A loud diastolic murmur was heard on auscultation, attributed to the acute onset of aortic valve dysfunction.A transthoracic echocardiogram confirmed the diagnosis of aortic valve insufficiency and revealed an intimal flap inside a dilated aortic root.A computed tomography scan confirmed our suspicion of acute type a aortic dissection, with a dilated false lumen occluding nearly completely the bifurcated stent graft, explaining the ischemic changes observed in the lower extremities.The patient underwent an urgent open operation performed by a cardiac surgical team, followed by a percutaneous endovascular procedure performed by an interventional radiologist and a vascular surgeon to restore blood flow at the aortoiliac level.After the aortic root was reconstructed by a bentall procedure, the patient was transferred to the catheterization laboratory under general anesthesia, where an aortography showed the vascular anatomy expected after the bentall procedure and aortic arch replacement, as well as a marked decrease in blood flow through the false lumen.The previously compressed stent graft was reexpanded, but the blood flow through its lumen remained slow and was completely absent through the left renal artery.Residual iliac artery stenoses were present distal to the ends of both bifurcated stent segments.Balloon angioplasties of the left renal artery and left and right iliac arteries stenoses were performed, followed by stent implantations.The patient was then returned to the operating room for persistent bleeding through the chest tubes, although no distinct hemorrhagic source was identified.After 11 hours of complex surgical and percutaneous interventions, the patient was admitted to our intensive care unit with palpable femoral pulses and a severe revascularization syndrome of the right lower extremity that required extensive open fasciotomy on day 1 postoperatively.Despite a postoperative period further complicated by transient oligoanuria, the patient was discharged from the hospital on day 13 in stable condition and with peripheral pulses palpable bilaterally.At 2.5 years of follow-up, the patient has remained free of symptoms.An echocardiogram obtained 24 months after the hybrid procedure showed no regional wall motion abnormality, a left ventricular ejection fraction of 0.57, and normal prosthetic aortic valve function.A computed tomography scan showed the stent graft was patent.The article provided the following additional statements in regards to the collapse of the gore® excluder® aaa endoprostheses: the endovascular graft behaved like a true vascular lumen with respect to the dissection process.Although the stent graft was completely collapsed by the pressure inside the false lumen, it reexpanded after repair of the proximal aorta.The stent graft caused a markedly decreased perfusion of the lower extremities and the pelvic vessels by preventing the return of blood flow at the distal end of the dissected membrane near the aortic bifurcation.Because the stent graft was collapsed, the dissection extended into both common iliac arteries and ended in blind pockets immediately distal to the stent graft.The latter ultimately became occluded by a thrombus, which most likely developed during the 6 hours that elapsed between the onset of dissection and the surgical repair.Repair of the proximal aorta allowed reexpansion of the stent, but short segments of both common iliac arteries remained occluded by the mechanical compression of the thrombosed blind pockets at the distal end of the false lumen.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: joerg kersten ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8606969
• MDR Text Key: 144935797
• Report Number: 2017233-2019-00347
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 57 YR