MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-P-24-105

Device Problems Complete Blockage (1094); Off-Label Use (1494); Obstruction of Flow (2423)

Patient Problems Stroke/CVA (1770); High Blood Pressure/ Hypertension (1908); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Description of event according to initial reporter: patient involved in motorcycle accident (b)(6) 2021 and as a result had an urgent late night repair of an aortic transection along with other major surgeries from other specialties.The grafts used were a tbe-22-80-pf ((b)(4)) distally, and a zta-p-24-105 ((b)(4)- this complaint) proximally landing at the lsca.Dr was aware that graft not indicated for blunt thoracic aortic injury (btai) but chose to proceed as these were the only grafts available on consignment in the diameter he required.Dr was very happy with on table result.Dr has now supplied a latest cta which appears to show significant disease formation throughout both grafts.He mentioned the patient has suffered a stroke, and high blood pressure.They were not on an anti coagulant regimen.Plans to reline the grafts and put patient on a anticoagulant (warfarin) regimen moving forward.Dr said he is happy for the occurrence to be recorded but did not feel it was a product complaint as he believes the patient has some kind of thrombotic disorder.Patient outcome: an adverse effect due to this occurrence was reported.It was mentioned that the patient suffered a stroke and high blood pressure.

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): p140016.Investigation is still in progress.

Event Description

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

Manufacturer Narrative

Manufacturers ref#: (b)(4).Summary of investigational findings: a 23-year-old male patient involved in a motorcycle accident was emergently treated with a zta-p-24-105 (complaint device) and a tbe-22-80-pf (b)(4) in april 2021 to repair a traumatic descending thoracic aortic transection.The physician was aware that grafts are not indicated for blunt thoracic aortic injury (btai) but chose to proceed as these was the only option in consignment of the diameter he required.The patient presented on (b)(6) 2022 with hypertension and a stroke.Full recovery from the stroke was anticipated.The patient was not anti-coagulated after procedure.A latest cta revealed thrombus formation throughout both grafts.As the additional treatment, the physician decided to reline the existing grafts by first placing a tbe-22-80-pf distally, and then a tbe-24-80-pf proximally.The 22-80 appeared constrained by the thrombus so the physician used a coda balloon to gently create more space, but it never opened completely and was utilized.The patient was placed on the anti-coagulated treatment for 90 days.A cta and angiography from the additional intervention were provided along with the complaint report and reviewed by an imaging expert.Per the findings in the imaging review, the cta confirmed thrombus in both endografts.The tbe-22-80 lumen was significantly narrowed by the thrombus.The zta-p and tbe were appropriately sized and normally implanted.A pseudoaneurysm of the superior vena cava or right atrium was associated with pericardial density consistent with thrombus.The internal mammary arteries were hypertrophied.The left kidney and spleen were absent.The right mid and inferior renal cortex was thinned to absent in multiple locations.These defects were likely remote and related to trauma rather than ongoing embolization.The bowel was normal.Also, per the findings in the imaging review, angiography from the additional intervention showed the intragraft mural thrombus angiographically correlated with the cta appearance.Constraint of the tbe used to reline the distal endograft matched the mural thrombus location and appearance.The constraint was significantly reduced by relining with two tbe endografts and post implantation molding balloon angioplasty.Per the impressions in the imaging review, blood pressure in the right kidney would have been reduced by the intragraft thrombus.The lower blood pressure would have triggered a renin angiotensin response and increased systemic blood pressure.Consequently, the thrombus was directly responsible for the high blood pressure.Because the thrombus was downstream all the aortic arch branches, it was unlikely a direct cause of embolic stroke.It could have indirectly been related to stroke through a hypertensive hemorrhage.The bare stent could have been a source of emboli to the left vertebral artery and therefore directly related to the stroke.However, at the time of the scan, no thrombus was present on the bare stent.Additionally, there was no evidence of acute or subacute embolization to the right kidney or bowel.Internal mammary artery hypertrophy indicates that the mural thrombus was long standing.These arteries gradually hypertrophy as collateral pathways around the aortic stenosis.The svc (superior vena cava) or ra (right atrium) pseudoaneurysm represents a contraindication to anticoagulation.Review of the device history record gave no indication of the device being produced out of specification.Per the instructions for use, risk of in-graft thrombus has been observed when the zenith alpha endovascular graft has been used to treat blunt thoracic aortic injuries.The instructions for use states that thrombosis is a potential adverse event.Based on the provided information and the imaging review, an exact cause was not established.However, thrombus formation has been known to occur in btai patients why the device is not intended for use in this patient population.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.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• 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: 14487119
• MDR Text Key: 292483184
• Report Number: 3002808486-2022-00735
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346779
• UDI-Public: (01)10827002346779(17)220402(10)E3838067
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

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 Expiration Date: 04/02/2022
• Device Catalogue Number: ZTA-P-24-105
• Device Lot Number: E3838067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2022
• Initial Date FDA Received: 05/24/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR
• Patient Sex: Male