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

Model Number	G53451
Medical Device Problem Codes	Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer ref# (b)(4).Investigation is still in progress.
Event or Problem Description
Description of event according to study: graft kink.On (b)(6) 2015, the patient received a zteg-2pt-40-208-pf-us.There were no difficulties deploying the device.A molding balloon was not used.No patient-related adverse events were observed during the procedure.Per site and analysis, the device was patent with no kink or endoleak on the completion angiogram.The patient was discharged from the hospital on (b)(6) 2015 (three days post-procedure).(b)(6) 2015 ct scan (40 days post-procedure): analysis: graft patent and intact with no kink or endoleak.Aneurysm diameter = 77.7 mm.(b)(6) 2015 ct scan (185 days post-procedure): analysis: graft patent and intact with no migration, kink, or endoleak.Aneurysm diameter = 67.9 mm.Analysis also noted < 1 cm distal seal zone.(b)(6) 2016 ct scan (381 days post-procedure): cranial migration and unknown endoleak ((b)(4)).(b)(6) 2020 analysis review of a ct performed on (b)(6) 2019 revealed a patent and intact graft with no endoleak present.A kink was identified and the location was noted as, ¿distal aortic arch/proximal descending thoracic aorta.¿ analysis also noted the following, ¿at 48 months, there was very early narrowing of the device due to angulation, but at 60 months, the angulation is now definitely causing device compression and is now classified as a "kink".Patient outcome: the patient completed and exited the study on (b)(6) 2019, no plans for intervention were noted.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Manufacturers ref# (b)(4).Summary of investigational findings: a 85 year old male underwent tevar (thoracic endovascular aortic repair) to repair a proximal descending thoracic aneurysm.A zteg-2pt-40-208-pf-us (complaint device) was used in 2015 for the procedure.In 2016 a cranial migration and unknown endoleak was observed.In 2019 a new follow up ct scan revealed a kink at ¿distal aortic arch / proximal descending thoracic aorta.¿ no adverse effects to the patient have been reported due to this occurrence.Cta imaging was provided and reviewed by an imaging expert.Per the imaging review a kink of the stentgraft was confirmed, due to aortic lengthening at 6-12 months post-op.Based on the information and imaging provided it is likely that the kink has developed as a result of disease progression / patient condition.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.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 TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
• Common Device Name: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9966547
• Report Number: 3002808486-2020-00410
• Device Sequence Number: 19818418
• Product Code: MIH
• UDI-Device Identifier: 10827002534510
• UDI-Public: (01)10827002534510(17)170428(10)E3209058
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P070016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2017
• Device Model Number: G53451
• Device Catalogue Number: ZTEG-2PT-40-208-PF-US
• Device Lot Number: E3209058
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/06/2020
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 04/16/2020
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 102