MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZDEG-P-34-204-PF

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Event Date 01/10/2023

Event Type  Injury  

Event Description

Description of event according to initial reporter: on (b)(6) 2020 during the index procedure, a zdes-36-36-180, zdeg-p-32-202-pf, and zdeg-p-34-204-pf were implanted without difficulty with (b)(4) degree of oversizing.Primary indication for implant was aortic dissection.The primary tear was descending aorta, distal to left subclavian.The proximal location of the dissection was descending aorta, distal to left subclavian and the distal location was the left internal iliac.The proximal seal zone had no tortuosity, occlusive disease, calcification, or thrombus.The procedure angiography showed a proximal zone of graft implantation was zone 3.The left subclavian artery was partially covered with revascularization.The thoracic and abdominal false lumens were patent with collateral flow at the lower back.At the end of the procedure the devices were patent with no separation and no evidence of device integrity issues.On (b)(6) 2020 (4 days post procedure) a computed tomography (ct) revealed the devices were patent with no separation, migration, and no evidence of device integrity issues.The thoracic false lumen was completely thrombosed, and abdominal false lumen was patent with collateral at the lumbar artery.There was no imaging done at six-month follow-up visit.On (b)(6) 2021 (95 days post procedure) a follow-up ct revealed the device was patent with no migration, separation, or device integrity issues.The thoracic false lumen was completely thrombosed, and abdominal false lumen was patent with flow through collaterals at intercostal.On (b)(6) 2022 (460 days post-procedure) ct showed thoracic false lumen completely thrombosed and abdominal false lumen patent with flow through collaterals at intercostal.The left subclavian artery was occluded with all other vessel patent.The devices were patent with no separation or migration and no evidence of device integrity issues.There was no imaging at the two year follow-up.On (b)(6) 2023 (824 days post-procedure) a follow-up ct revealed thoracic and abdominal false lumens patent with flow through a primary tear type ib-distal endoleak.All vessels were patent.The devices were patent with no separation, evidence of migration or device integrity issues.Patient outcome: the patient did not experience any adverse effects or require additional procedure due to this occurrence.

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device marketed under pma/510(k): p180001.Investigation is still in progress.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.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: a subject of complaint is an 81-year-old male patient, who is enrolled in the french reimbursement study and treated for aortic dissection.On (b)(6) 2020 during the index procedure, a zdeg-p-32-202-pf, zdeg-p-34-204-pf (complaint device) and a zdes-36-36-180 were implanted accordingly without difficulty with 0% degree of oversizing.The primary tear was in the descending aorta, distal to left subclavian.The proximal location of the dissection was descending aorta, distal to left subclavian and the distal location was the left internal iliac.The proximal seal zone had no tortuosity, occlusive disease, calcification, or thrombus.The procedure angiography showed a proximal zone of graft implantation was zone 3.The left subclavian artery was partially covered with revascularization.The thoracic and abdominal false lumens were patent with collateral flow at the lower back.At the end of the procedure the devices were patent with no separation and no evidence of device integrity issues.On (b)(6) 2020 (4 days post procedure) ct (computed tomography) revealed the devices were patent with no separation, migration, and no evidence of device integrity issues.The thoracic false lumen was completely thrombosed, and abdominal false lumen was patent with collateral at the lumbar artery.There was no imaging done at six-month follow-up visit.On (b)(6) 2021 (95 days post procedure) a follow-up ct revealed the device was patent with no migration, separation, or device integrity issues.The thoracic false lumen was completely thrombosed, and abdominal false lumen was patent with flow through collaterals at intercostal.On (b)(6) 2022 (460 days post-procedure) ct showed thoracic false lumen completely thrombosed and abdominal false lumen patent with flow through collaterals at intercostal.The left subclavian artery was occluded with all other vessel patent.The devices were patent with no separation or migration and no evidence of device integrity issues.There was no imaging at the two-year follow-up.On (b)(6) 2023 (824 days post-procedure) a follow-up ct revealed thoracic and abdominal false lumens patent with flow through a primary tear type 1b distal endoleak.All vessels were patent.The devices were patent with no separation, evidence of migration or device integrity issues.Patient remains in the study.No other secondary interventions or adverse events related to the type 1b endoleak have been reported.Review of the device history record gave no indication of the device being produced out of specification.No imaging was provided for the investigation.Several attempts to obtain additional information have been made, but no further info is received.Based on the limited provided information it has not been possible to establish a cause for the type 1b endoleak.Furthermore, it is difficult to determine whether it is a true endoleak or the flow into the false lumen.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.

Manufacturer Narrative

Manufacturers ref# (b)(4).D1) corrected from "zenith tx2 dissection endovascular graft straight component" to "zenith® dissection endovascular stent".Investigation is still in progress.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 TX2 DISSECTION ENDOVASCULAR GRAFT STRAIGHT COMPONENT
• 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; bjaeverskov 4632 ; DA 4632
• Manufacturer Contact: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 18158375
• MDR Text Key: 328356022
• Report Number: 3002808486-2023-00279
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002242798
• UDI-Public: (01)10827002242798(17)230901(10)E4013025
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

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: 09/01/2023
• Device Catalogue Number: ZDEG-P-34-204-PF
• Device Lot Number: E4013025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 01/16/2024
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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): Other
• Patient Age: 81 YR
• Patient Sex: Male
• Patient Weight: 70 KG