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

Model Number	G35335
Medical Device Problem Codes	Entrapment of Device (1212); Off-Label Use (1494); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Thrombosis/Thrombus (4440); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Link to tweets on (b)(4): (b)(6).Investigation is still in progress.
Event or Problem Description
Description of event according to tweet: have you ever seen a new dissection flap inside a stendt graft? tweet: i have @washuvascular.26 mm @cookvascular alpha placed for aberrant l sca (left subclavian artery) in a right sided arch.Presented with htn (hypertension) and aki (acute kidney injury) to clinic.50 mmhg pressure differential, looked like delaminated thrombus on #ivus (intravascular ultrasound).Patient outcome: unknown.
Event or Problem Description
Additional information received 10may2022: patient outcome: patient required an additional procedure, relining with c-tag.Adverse effect reported: hoarseness from intubation, normalization of bp and cr post procedure.Transient aki and htn, both resolved post revision.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).G4) 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.
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Summary of investigational findings: this complaint was discovered on twitter.The event was registered based of a physician's (2) reply to a twitter post, where a physician (1) asked if anyone else has experienced a second dissection within the graft, where tevar was done for tbad (type b aortic dissection).The physician (2) responded that he had seen this before with a zta-p-26-105-w (complaint device), which was placed in right sided arch with kommerell diverticul at aberrant left subclavian artery.Per physician (2), it looked like delaminated thrombus on ivus.The patient underwent relining with an endograft from an other manufacturer.Four ct studies, an angiography procedure, and 2 video clips of an angiogram and ivus study are provided along with the complaint report and reviewed by an imaging expert.Per the impressions in the imaging review, at 42 months, there is diffuse intraluminal web-like thrombus extending from the proximal zta graft to just beyond the distal graft edge.This is not an intraluminal dissection, but segments of mural and delaminated thrombus in continuity.Per the findings in the imaging review, on preop imaging, the right-sided aortic arch has a very narrow radius of curvature (6.5 mm) affecting the proximal landing zone at the rsa origin.There is focal narrowing of the proximal zta graft to a minimum lumen diameter of 18 mm with a ¿step-off¿ appearance at overlapping stent segments along the lesser curve.At least part of the delaminated thrombus appears to extend from this stent segment.The narrow arch angulation is outside the ifu for this device and likely contributed to the thrombus formation.Also per the findings in the imaging review, the re-lined components from an other manufacturer appear widely patent with no intraluminal thrombus seen.The proximal focally narrowed segment still measures about 18 mm in diameter but there is a more evenly contoured appearance of the graft here rather than a step-off appearance as previously seen.The distal extension graft diameter is 21 mm with no intimal thickening or thrombus.Per the ifu, the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with for ulcers/saccular aneurysms of the descending thoracic aorta.Also, per the ifu, aortic arch radius of curvature should be = 20 mm.Review of the device history record gave no indication of the device being produced out of specification.Based on the provided information and imaging review, the narrow arch angulation likely contributed to the thrombus formation.It is noted that the device is used for a patient with kommerell diverticul in a subclavian artery which is outside of intended use.Cook medical will continue to monitor for similar events.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• Common Device Name: 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: 14344583
• Report Number: 3002808486-2022-00303
• Device Sequence Number: 6256392
• Product Code: MIH
• UDI-Device Identifier: 10827002353357
• UDI-Public: (01)10827002353357(17)190321(10)E3430020
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: G35335
• Device Catalogue Number: ZTA-P-26-105-W
• Device Lot Number: E3430020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2022
• Supplement Date Received by Manufacturer: 05/10/2022; 11/28/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 05/30/2022; 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown