MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	G32539
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
This graft was implanted on (b)(6) 2015.There was no real issues.It may have had a slight type i endoleak and they wanted to follow patient.In the procedure that was the secondary one that was performed on (b)(6) 2018.The patient was brought in and accessed with brachial cut down on the left arm.Initially a 6 x 70 ansel sheath was used but was not long enough to reach the renal.It was changed to 7 x 90 pinnacle sheath.The right renal was then cannulated with an angled glide catheter.An angiography was performed and no leak was visible or issue in the renal.A rosen wire was then exchanged and the large flash ostial dual lumen balloon was used to support the renal stent and flare the back end.The stent seemed to flare well.Then another angiography was done.This then showed a more obvious type i endoleak on the distal or bottom portion of the fenestration into the sack.A gap could be seen between the stent and the gold marks.From here access was obtained percutaneously through the left groin and then a 6 fr sheath was brought up to try to cannulate the small opening on the fenestration.After many attempts the physician went back to the wire and sheath coming from the arm since they were unsuccessful from the groin.He was able to gain access from above and placed a total of 6 large cook coils.A final run was done and had a slight leak but vastly improved.The physician will do a follow up ct in about 30 days.
Event or Problem Description
This graft was implanted on (b)(6) 2015.There was no real issues.It may have had a slight type i endoleak and they wanted to follow patient.In the procedure that was the secondary one that was performed on (b)(6) 2018.The patient was brought in and accessed with brachial cut down on the left arm.Initially a 6 x 70 ansel sheath was used but was not long enough to reach the renal.It was changed to 7 x 90 pinnacle sheath.The right renal was then cannulated with an angled glide catheter.An angiography was performed and no leak was visible or issue in the renal.A rosen wire was then exchanged and the large flash ostial dual lumen balloon was used to support the renal stent and flare the back end.The stent seemed to flare well.Then another angiography was done.This then showed a more obvious type i endoleak on the distal or bottom portion of the fenestration into the sack.A gap could be seen between the stent and the gold marks.From here access was obtained percutaneously through the left groin and then a 6 fr sheath was brought up to try to cannulate the small opening on the fenestration.After many attempts the physician went back to the wire and sheath coming from the arm since they were unsuccessful from the groin.He was able to gain access from above and placed a total of 6 large cook coils.A final run was done and had a slight leak but vastly improved.The physician will do a follow up ct in about 30 days.
Additional Manufacturer Narrative
The device was not returned for evaluation.Imaging was received and reviewed by william cook australia medical director, who stated "the images fit the story provided in the complaint summary.The leak was from the right renal fenestration below the renal bridging stent.This would make it a type iii endoleak, and not a type i as described in the complaint form." work order ac949549 was reviewed and appears complete and correct.The device ifu states: "the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established.All patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms, changes in the structure or position of the endovascular graft, or stenosis/occlusion of vessels accommodated by fenestrations) should receive enhanced follow-up." "after endovascular graft placement, patients should be regularly monitored for perigraft flow, aneurysm growth, patency of vessels accommodated by a fenestration/scallop, or changes in the structure or position of the endovascular graft.At a minimum, annual imaging is recommended, including: abdominal radiographs to examine device integrity (separation between components, stent fracture or barb separation) contrast and non-contrast ct to examine aneurysm changes, perigraft flow, patency, tortuosity and progressive disease.If renal complications or other factors preclude the use of image contrast media, abdominal radiographs and duplex ultrasound may provide similar information." "intervention or conversion to standard open surgical repair following initial endovascular repair should be considered for patients experiencing enlarging aneurysms, unacceptable decrease in fixation length (vessel and component overlap) and/or endoleak.An increase in aneurysm size and/or persistent endoleak may lead to aneurysm rupture." "potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak; endoprosthesis: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft material wear; dilatation; erosion; puncture; perigraft flow; barb separation and corrosion." "all patients should be advised that endovascular treatment with this device requires lifelong, regular follow-up to assess their health and the performance of their endovascular graft.Patients with specific clinical findings (e.G., endoleaks, enlarging aneurysms, or changes in the structure or position of the endovascular graft) may require additional follow-up.Patients should be counseled on the importance of adhering to the follow-up schedule, both during the first year and at yearly intervals thereafter.Patients should be informed that regular and consistent follow-up is a critical part of ensuring the ongoing safety and effectiveness of endovascular treatment of abdominal aneurysms with this device.Physicians should evaluate patients on an individual basis and prescribe follow-up relative to the needs and circumstances of each individual patient." from the information received in this complaint, a definitive root cause could not be determined to identify the cause of the type iii endoleak at the right renal fenestration below the renal bridging stent.It is possible that one or more of the following factors contributed the complaint: insufficient sizing of the renal bridging stent.Insufficient flaring of the proximal end of the renal stent.Insufficient positioning of renal bridging stent.Factors relating to the procedure.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• MDR Report Key: 7535679
• Report Number: 9680654-2018-00019
• Device Sequence Number: 1862274
• Product Code: MIH
• UDI-Device Identifier: 10827002325392
• UDI-Public: (01)10827002325392(17)180211(10)AC949549
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2018
• Device Model Number: G32539
• Device Catalogue Number: ZFEN-P-2-36-137-R
• Device Lot Number: AC949549
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 07/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR