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

Catalog Number ZFEN-D-20-62-94

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Inflammation (1932); Myocardial Infarction (1969); Heart Failure (2206); Hematuria (2558)

Event Date 11/02/2016

Event Type  Injury  

Event Description

Devices implanted on (b)(6) 2016: cook devices = zpen-p-2-28-124 (ac982361), zpen-d-20-62-94 (ac982360), tfle-12-90-zt (7134510) right iliac leg.Non-cook devices = medtronic hippocampus renal rx stent 8mm*20mm right renal artery, gore viabahn stent 8mm*25mm left renal artery.The following post-procedure information has been provided: abdominal ultrasound examination was performed at 22:40 on (b)(6) 2016, which suggested right perirenal hematoma.At 1:45 on (b)(6) 2016 emergency angiography was performed through femoral artery puncture.The result showed contrast leakage at the junction of aortic stent and right iliac artery.Two stents (medtronic 2613120) were implanted in the right iliac artery.Intraoperative ultrasound exploration showed no obvious progress of retroperitoneal hematoma, and femoral artery incision was closed.The patient's vital signs were stable.The patient continued to have gross hematuria and hemoglobin decreased after surgery.So, another renal arteriography and iliac arteriography were performed at 23:00 on (b)(6) 2016.This time the contrast leakage at the right renal artery was detected, and renal artery embolization was performed.After surgery on (b)(6) 2016, the patient retained the foley catheter, showing gross hematuria.The patient was diagnosed with acute myocardial infarction and acute left heart failure on (b)(6) 2016, treated with medication.Later acute pancreatitis was diagnosed without a clear onset date, then patient was treated with medication.The patient was discharged and transferred to a lower level hospital on (b)(6) 2016.

Event Description

Devices implanted on (b)(6) 2016: cook devices = zpen-p-2-28-124 (ac982361), zpen-d-20-62-94 (ac982360), tfle-12-90-zt (7134510) right iliac leg non-cook devices = medtronic hippocampus renal rx stent 8mm*20mm right renal artery, gore viabahn stent 8mm*25mm left renal artery the following post-procedure information has been provided: 1.Abdominal ultrasound examination was performed at 22:40 on (b)(6) 2016, which suggested right perirenal hematoma.At 1:45 on (b)(6) 2016 emergency angiography was performed through femoral artery puncture.The result showed contrast leakage at the junction of aortic stent and right iliac artery.Two stents (medtronic 2613120) were implanted in the right iliac artery.Intraoperative ultrasound exploration showed no obvious progress of retroperitoneal hematoma, and femoral artery incision was closed.The patient's vital signs were stable.The patient continued to have gross hematuria and hemoglobin decreased after surgery.So, another renal arteriography and iliac arteriography were performed at 23:00 on (b)(6) 2016.This time the contrast leakage at the right renal artery was detected, and renal artery embolization was performed.2.After surgery on (b)(6) 2016, the patient retained the foley catheter, showing gross hematuria.3.The patient was diagnosed with acute myocardial infarction and acute left heart failure on (b)(6) 2016, treated with medication.4.Later acute pancreatitis was diagnosed without a clear onset date, then patient was treated with medication.The patient was discharged and transferred to a lower level hospital on (b)(6) 2016.

Manufacturer Narrative

The device was not returned for evaluation.Confirmation was received that no further information or medical imaging is available for this complaint.Work order (b)(4) was reviewed and appears complete and correct."endoleak" is listed as a potential adverse event.The device ifu states: - "patients with specific clinical findings (e.G.,endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive additional follow-up" - "the long-term performance of endovascular grafts has not yet been established.All patients should be advised that endovascular treatment requires life long, regular follow-up to assess their health and 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) should receive additional follow-up" based on the information received it is difficult to determine an exact root cause for the difficulty reported in this complaint.It is possible that the following factors may have contributed to the complaint: - inadequate distal opposition to vessel wall - incorrect sizing - graft not fully conformed to vessel wall.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY
• Type of Device: 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: 9227176
• MDR Text Key: 164068757
• Report Number: 9680654-2019-00044
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002385976
• UDI-Public: (01)10827002385976(17)190927(10)AC982360
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

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
• Device Expiration Date: 09/27/2019
• Device Catalogue Number: ZFEN-D-20-62-94
• Device Lot Number: AC982360
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 10/03/2019
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR