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-34-113

Device Problems Loss of or Failure to Bond (1068); Improper or Incorrect Procedure or Method (2017)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Pma/510k: similar to device marketed under zta-p-34-113-w.Pma/510k investigation is still in progress.

Event Description

Description of event according to initial reporter: type 1a ((b)(4)) and type 1b ((b)(4)) endoleaks identified on cta (devices implanted last year).Devices: e3790444 - tbe-34-77-pf and e3906988 - zta-p-34-113.Patient outcome: no unintended part of the device remained inside the patient's body.The grafts remained insitu.Additional procedure was required due to this occurrence - will require extending seal proximally and distally - date of reintervention unknown.No adverse effect on the patient was reported due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a 74-year-old female patient with a thoracoabdominal aortic aneurysm underwent an emergent tevar (thoracic endovascular aortic repair) in 2021, where a zta-p-34-113 and a tbe-34-77-pf were implanted.Ivus has been used for planning and sizing.A cta dated 20jul2022 revealed a type 1a endoleak related to the tbe-34-77-pf (b)(4) and a type 1b endoleak related to the zta-p-34-113 (complaint device).Per the reported information, the endoleaks will require extending seal proximally and distally, but the date of reintervention is unknown.A cta was provided along with the complaint report and reviewed by an imaging expert.The cta quality was limited as only 5mm slices were provided.Per the findings in the imaging review ¿the zta-p-p would have been too short to cover the intended to treat aneurysm alone.Aneurysms separate from the intended to treat taa engulfed the proximal tbe and the distal zta-p resulting in type ia and type ib endoleaks.The ib endoleak was contiguous with original aneurysm sac although the sac remained thrombus filled even on delayed imaging¿.Per respond on an additional query sent to imaging reviewer ¿the aorta was diseased beyond the ivus findings and implantation location.Without angiographic correlation of cta findings to guide implantation location, finding healthy vessel on ivus would be difficult.Probabilities favor insufficient coverage of non-aneurysmal but still diseased artery.Ivus is insufficient at evaluating thoracic aneurysms.The thoracic aortic lumen is large, ultrasound wall penetration can be limited, and lung behind present significant challenges in addition to imprecise spatial localization.So the probability of leaving disease uncovered was high.Also, the rapidity of recurrence favors insufficient coverage¿.Review of the device history record gave no indication of the device being produced out of specification.According to the ifu, contrast-enhanced spiral computed tomographic angiography (cta) with 3d reconstruction is the strongly recommended imaging modality to accurately assess patient anatomy, aortic diameter, proximal and distal neck lengths prior to treatment.Based on the provided information and imaging review, it is difficult to determine a conclusive cause.However, use of ivus for planning and sizing could have likely resulted in leaving the aneurysm uncovered.At the same time, the patient had diseased aorta beyond the ivus findings and implantation location.It is noted that zta is used in combination with tbe which is outside of intended use for zta.Zta may be used independently or in combination with a distal component.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: 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: 15155150
• MDR Text Key: 297136849
• Report Number: 3002808486-2022-00912
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346946
• UDI-Public: (01)10827002346946(17)221009(10)E3906988
• 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: 10/17/2022

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: 10/09/2022
• Device Catalogue Number: ZTA-P-34-113
• Device Lot Number: E3906988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 10/14/2022
• Supplement Dates FDA Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2019
• 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: 74 YR
• Patient Sex: Female