MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Ruptured Aneurysm (4436)

Event Type  Death  

Event Description

Description of event according to initial reporter: a patient with arch aneurysm due to syphilitic aortitis was treated with a hybrid repair including a zta.Later the aneurysm ruptured at the site of the debranching graft anastomosis and the patient died.Thoracic endo vascular aortic repair was performed from zone 0 to the descending thoracic aorta using a zenith alpha thoracic stent graft.Signs of left arm ischemia (pallor, pain, and paresthesia), for which it was decided to perform a left carotid-subclavian bypass using a 6mm graft from another manufacturer.Six-month follow-up computed tomography angiography showed complete exclusion of the aneurysm and no other aneurysm formation was observed in the remnant aorta.The following month, the patient was brought to the emergency room in cardiac arrest.Unsuccessful cardiopulmonary resuscitation maneuvers were performed.An autopsy showed cardiac tamponade due to rupture of the ascending aorta at the site of the debranching graft anastomosis.Patient outcome: patient died.

Manufacturer Narrative

Manufacturers ref# (b)(4).Catalog# is unknown but referred to as a zta device.Similar to device marketed under pma/510(k): p140016.Investigation is still in progress.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the subject of the complaint was an 82-year-old male patient with tertiary syphilis complicated by an aortic arch aneurysm and was undergoing treatment with penicillin.He had a medical history of hypertension, mild chronic kidney injury, and chronic hepatitis c infection with liver cirrhosis.The patient was considered unfit for an open aortic arch replacement because of his comorbidities.A total endovascular aortic arch repair was proposed, and a custom-made stent-graft was ordered.While waiting for the stent-graft the patient came to the emergency department with hemoptysis, sudden chest pain, and a history of syncope.At admission, he was hemodynamically stable.Computed tomography angiography (cta) showed the aortic arch aneurysm diameter had increased to 95 mm (initial 68 mm) from the origin of the brachiocephalic trunk to the upper descending aorta.Signs of contained hemorrhage into the aortic wall from the vasa vasorum, aortic wall thickening, and multiple ulcer-like projections of the aortic lumen were identified.Due to the emergency case, it was decided to perform a hybrid arch repair with debranching of supra-aortic vessels and tevar (thoracic endovascular aortic repair).The proximal portion of a graft from another manufacturer was anastomosed to the ascending aorta and one distal branch was anastomosed to the brachiocephalic trunk (bct) and one other branch was anastomosed to the left common carotid artery (lcca).Both bct and lcca were ligated.The left subclavian (lsa) was embolized.Following this a tevar was performed from zone 0 to the descending thoracic aorta using a zta stent-graft.Control intraoperative angiography showed complete exclusion of the aneurysm.Due to signs of left arm ischemia a left carotidsubclavian bypass was performed.Patient could be discharged on postoperative day 11.Six-month follow-up cta showed complete exclusion of the aneurysm and no other aneurysm formation was observed in the remnant aorta.The following month, the patient was brought to the emergency room in cardiac arrest.An autopsy showed cardiac tamponade due to rupture of the ascending aorta at the site of the debranching graft anastomosis.A clinical assessment was performed based on the journal article.According to clinical assessment, it is not possible to establish an exact conclusion to why the rupture, hence cardiac tamponade and patient death occurred.It is understood that the patient was diagnosed with tertiary syphilis complicated by the aortic arch aneurysm.The authors comment themselves that the ascending aorta anastomosis was performed in an aorta segment that may have been affected by syphilitic aortitis which could have been the reason for the rupture.It is unknown how much of the aorta was infected (hence also landing zone for zta).There are no indications of a fault zta device.According to the ifu (information for use) the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair and the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in patients with aortitis.Furthermore, aneurysm rupture and death is a known potential adverse event to tevar.Based on the provided information and the clinical assessment an exact cause is not possible to establish, but it seems likely that the outcome was caused by the patients underlying medical condition (syphilitic aortitis).It is noted that the zta was used in zone 0.It should also be noted that the hybrid procedure was chosen due to the emergency case (while awaiting a custom-made device) in a patient deemed unfit for conventional open surgery.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: UNKNOWN
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16582813
• MDR Text Key: 311674093
• Report Number: 3002808486-2023-00067
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 82 YR
• Patient Sex: Male