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

Device Problems Complete Blockage (1094); Collapse (1099)

Patient Problems Ischemia (1942); Occlusion (1984)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Date the incident occurred is unknown.Therefore the date of the article received by the journal was used as the event date.

Event Description

The following article was reviewed: ¿treatment of abdominal aortic endograft infolding¿ (martijn van dorp et al., j vasc endovasc surg, 2:20, date published: july 07, 2017).The event is described as follows in the article: the patient underwent elective endovascular aortic repair (evar) with iliac-branched device for the treatment of an aneurysm of the left common iliac artery with a diameter of 4.2 cm.Otherwise, the patient was healthy and led an active life.The pre interventional measurements by ct scan revealed a large aortic neck length of more than 10 cm with a straight configuration without angulation or calcifications.The distal neck diameter was 20 mm.Under a standard procedure, a gore® excluder® aaa endoprostheses (23x14x12) was implanted and a gore® excluder® iliac branch endoprostheses (ibe) was deployed for the perfusion of the left hypogastric artery.Balloon remodeling was performed in a standard manner.Completion angiography revealed adequate graft interposition, with exclusion of the iliac aneurysm and no signs of endoleak.The patient had an uneventful recovery and was discharged on the second postoperative day.A completion ct angiography, two weeks postoperatively, revealed accurate positioning of the endoprosthesis with correct wall apposition of the endograft.Three days later, the patient presented at the emergency department with bilateral acute limb ischemia rutherford classification iib, after a period of speed cycling.No palpable femoral pulses were present and patient had bilateral lower extremity motor and sensory loss.Ct angiography revealed infolding of the endoprosthesis with proximal collapse of the graft with luminal obliteration that was opted to be resolved via endovascular repair.After obtaining bilateral femoral access, retrograde angiography confirmed the collapse of the endoprosthesis.It was possible to pass a standard 0.035 terumo guidewire followed by a 5 fr pigtail guidewire through the collapsed body of the endoprosthesis.Passage of a 260 cm long, 0,035-inch diameter lunderquist super-stiff guide wire through the pigtail catheter already resulted in unfolding and re-expanding of the endograft.To fixate the proximal part of the endograft, a medtronic aortic cuff was implanted proximal, infrarenal with a 25 mm diameter.After ballooning, the completion angiogram was displaying adequate apposition of the cuff and the endoprosthesis.The completion ct angiography two days post-reintervention showed a patent endograft lumen without signs of infolding or endoleak, and a small non-flow-limiting dissection of the left external iliac artery.Initially, high levels of creatine kinase (ck) were present due to rhabdomyolysis, for which generous amounts of intravenous fluids were administrated.The patient was bothered by weakness of the right upper leg and impotence, however all symptoms completely disappeared after six weeks and follow-up ct angiography at one year revealed no signs of infolding and shrinkage of the iliac aneurysm.A possible arched posture of the back during cycling could have facilitated a posture dependent type ia endoleak.As documented by the adequate endograft wall apposition three days prior to the collapse, endograft infolding was not likely to be caused by intra procedural graft malexpansion and can be seen as an instant event.If a posture dependent type ia endoleak did exist, the right size of endoprosthesis might have not been chosen (the next available size endograft would have exceeded 20% oversizing).The endoprosthesis was positioned 1-1.5 cm below the renal arteries in a not dilated abdominal aorta.

Manufacturer Narrative

G3: added literature.H6: changed method code 1 to 4117.

• 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: 8606918
• MDR Text Key: 144943207
• Report Number: 2017233-2019-00346
• 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,litera
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR