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U.S. Department of Health and Human Services

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

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WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
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.
 
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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 Key9227176
MDR Text Key164068757
Report Number9680654-2019-00044
Device Sequence Number1
Product Code MIH
UDI-Device Identifier10827002385976
UDI-Public(01)10827002385976(17)190927(10)AC982360
Combination Product (y/n)N
PMA/PMN Number
P020018
Number of Events Reported1
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 Date09/27/2019
Device Catalogue NumberZFEN-D-20-62-94
Device Lot NumberAC982360
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/03/2019
Initial Date FDA Received10/23/2019
Supplement Dates Manufacturer Received10/03/2019
Supplement Dates FDA Received11/14/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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