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

Catalog Number ZTA-PT-44-40-179

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423)

Patient Problems Thrombosis (2100); Thrombosis/Thrombus (4440)

Event Date 11/09/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Investigation is still in progress.

Event Description

The patient was reported to be a (b)(6) female with a history of peripheral vascular disease, sigmadiverticulitis, stomach cancer, tia (transient ischemic attack), and smoking.The pre-procedure ct scan showed a stable type iii aneurysm.The maximum thoracoabdominal diameter measured 92 mm.The celiac artery, sma and both renal arteries were patent, with no evidence of renal infarcts.On (b)(6) 2017 the patient was treated with the following 6 cook devices: zta-pt-44-40-179: (b)(4), bfarm ref: (b)(4).(b)(4) bfarm ref: not assigned yet.Tbranch-34-18-202: (b)(4), bfarm ref# (b)(4).Zteg-2pt-42-32-165-pf: (b)(4) bfarm ref: (b)(4).(b)(4) bfarm ref: (b)(4).(b)(4) bfarm ref: not assigned yet.Unibody-22-132 distal body (william cook australia): (b)(4) bfarm ref.(b)(4).Zsle-16-74-zt right iliac leg graft (cook inc) (b)(4) bfarm ref: (b)(4).Zsle-20-74-zt left iliac leg graft (cook inc) (b)(4) bfarm ref: (b)(4).During investigation for the initial complaint for this patient additional finding of mild to moderate partial laminar thrombus in zta-pt-44-40-179 has been discovered.Consequently, a new complaint has been opened (this complaint (b)(4)) to address this new potential failure mode.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: this complaint was opened to address a finding of partial laminar thrombus in a zta-pt-44-40-179 device, noted in an imaging review performed for cook¿s investigation of related complaints.A 74-year-old female study patient underwent treatment for a thoracoabdominal aneurysm.Reported patient history includes peripheral vascular disease, sigma diverticulitis, stomach cancer, tia, and smoking (current).On (b)(6) 2017 the patient received the following devices: zta-pt-44-40-179, tbranch-34-18-202, zteg-2pt-42-32-165-pf, unibody-22-132, zsle-16-74-zt (right iliac leg graft), zsle-20-74-zt (left iliac leg graft).As per the imaging review, from a 6-month postop ct study, dated (b)(6) 2018, a zenith thoracic alpha (zta tapered 44 x 40 x 179 mm) graft begins 41 mm distal to the lsa.There is a long length of proximal seal.The zta graft has mild to moderate partial laminar thrombus throughout.A zteg thoracic graft overlaps 53 mm with the distal zta graft and extends to the distal thoracic aorta.There is moderate tortuosity adjacent to the overlap segment but no endoleak is seen here.The zteg graft has mild intermittent laminar thrombus.The zteg graft diameter narrows to 30 mm distally.From a 18-month postop ct study, dated (b)(6) 2021, the thrombus inside the zta appears to be significantly reduced.No information regarding medical treatment in relation to this event has been received.Related (b)(4) was opened to address thrombus inside the overlapping zteg device.As per imaging expert findings the 6 months post-op ct shows the zta graft to have a mild to moderate partial laminar thrombus throughout and the adjacent zteg graft has a mild intermittent laminar thrombus.The laminar thrombus in the zta graft is significantly reduced at 18 months post-op and no residual thrombus is seen in the zteg graft.It is the imaging expert´s impression that the moderate laminar thrombus within the zta and zteg stent-grafts at 6 months likely are due to non-laminar flow from stent-graft tortuosity and caliber change with the stent-graft diameter reducing from 44 mm at the proximal zta to 30 mm at the distal zteg.A clinical assessment was also performed for the investigation.As per assessment "the patient is undoubtedly heavily predisposed for thrombus formation as in the different clinical imaging heavy calcification of the vascular system is seen.The heavy calcification along with the patient¿s malignant condition (stomach cancer) and current smoking theoretically places the patient in the upper extreme of the scale for risk of thrombo-embolic events including formation of the confirmed laminar thrombus within the endo-grafts.No information about the patient¿s pharmacological treatment such as anticoagulants, cholesterol management, hypertension treatment etc.Is available." it was concluded: "in conclusion, there is no indication in the available medical records, clinical imaging assessments etc.That this multimorbid patient¿s condition or treatment was in any way deteriorated or prolonged due to malfunctioning of the device or device non-conformance.There is no information indicative of device failure." "it must be stressed, that on the grounds of the information available in the complaint one cannot definitively determine whether the thrombus formation was related to the devices themselves or was a result of the patient¿s progressed atherosclerotic state and/or heavy general predisposition for thrombus formation.Nor can one conclude if the need for a re-intervention procedure was related to the use of the devices or would have been indicated regardless of the kind of primary intervention chosen." instructions for use (ifu) states that no localized angulation should be larger than 45 degrees.The zenith alpha thoracic endovascular graft is a two-piece cylindrical endovascular graft consisting of proximal and distal components.The ifu also lists arterial or venous thrombosis as a potential adverse event.Review of the device history record gave no indication of the device being produced out of specifications.Based on the provided information and review of provided imaging, a cause for the thrombus formation could not be determined.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 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 TAPERED COMPONENTS
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 10790671
• MDR Text Key: 217312334
• Report Number: 3002808486-2020-01003
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002346564
• UDI-Public: (01)10827002346564(17)200710(10)E3601003
• Combination Product (y/n): N
• PMA/PMN Number: P140016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,study
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

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: 07/10/2020
• Device Catalogue Number: ZTA-PT-44-40-179
• Device Lot Number: E3601003
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/05/2020
• Supplement Dates Manufacturer Received: 07/19/2021
• Supplement Dates FDA Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 56