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-32-202-PF

Device Problems No Apparent Adverse Event (3189); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 11/16/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): p180001.Investigation is still in progress.

Event Description

Description of event according to the initial reporter: on (b)(6) 2020 during the index procedure, a zdeg-pt-32-202-pf (lot# e4019227) as well as 2 zdes devices {catalog# zdes-36-120 (lot# e3925526) and catalog# zdes-36-180 (lot# e4024347) were implanted without difficulty.The degree of oversizing was not reported.A molding balloon was used for ¿compression of false lumen¿ during the procedure.A query has been placed for more information on the balloon use.No other devices were placed.Primary indication for implant was an aortic dissection.The primary tear was distal to the left subclavian artery.The proximal location of the dissection was distal to the left subclavian artery and the distal location was the infrarenal aorta.There were no reported re-entry tears.Details on the proximal landing zone were not reported.The graft fabric did not cover the left subclavian artery.The device was patent without device integrity issues at the end of the procedure.Continued flow into the false lumen was reported through an unknown source.A query has been placed to verify the source could not be determined.The patient was discharged on (b)(6) 2020.On (b)(6) 2021 (123 days post-procedure), the patient had a secondary intervention to place a distal extension.The secondary intervention was marked as not successful due to ¿persistence of a distal endoleak 1b¿.Queries have been placed to determine when endoleak was first noted as the onset date of the event is the day of procedure yet it has not been reported prior to this secondary intervention.Patient outcome: the patient remains in the study.No plans for further intervention have been reported.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Event Description

Additional information received on 21mar2022: the indication for the second procedure was type ib endoleak (tevar) with increased aortic diameters at 3 months.Rpn and lot for the distal extension - zta-p 34-161 lot:e3984594 the endoleak refer to blood flow into the false lumen.The distal extension implanted during the second procedure was intra-stent bare (zdeg) / dissected aorta.

Manufacturer Narrative

Manufacturer ref# (b)(4).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.

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).After investigation the event for (b)(4) is no longer reportable.Summary of investigational findings: a 70-year-old male patient underwent tevar on (b)(6) 2020 where a zdeg-pt-32-202-pf as well as 2 zdes devices zdes-36-120 and zdes-36-180 were implanted without difficulty.The degree of oversizing was not reported.A molding balloon was used for ¿compression of false lumen¿ during the procedure.Primary indication for implant was an aortic dissection.The proximal location of the dissection was distal to the left subclavian artery and the distal location was the infrarenal aorta.There were no reported re-entry tears.Details on the proximal landing zone were not reported.The graft fabric did not cover the left subclavian artery.The device was patent without device integrity issues at the end of the procedure.Continued flow into the false lumen was reported through an unknown source.The patient was discharged on (b)(6) 2020.On (b)(6) 2021 (123 days post-procedure), the patient had a secondary intervention to place a distal extension (zta-p-34-161).The secondary intervention was marked as not successful due to ¿persistence of a distal endoleak 1b¿.Per requested information endoleak refer to blood flow into the false lumen.It is reported that the patient remains in the study and no plans for further intervention have been reported.Review of device history record gave no indication of the device being produced outside of specifications.A pre-operative and post-operative ct were provided and reviewed by an imaging expert.On pre-operative ct scan of (b)(6) 2020 the imaging reviewer found ¿the celiac and sma are perfused by the true lumen with a re-entry tear at the origin of the celiac.The lra is perfused by the false lumen with multiple re-entry tears in the abdominal aorta.The rra is extremely diminutive with atrophy of the right kidney.¿ on 6 weeks post-operative ct the imaging reviewer found ¿there is retrograde false lumen perfusion from the distal ta adjacent to the zdes stent (above the celiac) to the mid ta around the distal zdeg graft.There is no flow between the distal graft and intima, so this is not a true endoleak.The false lumen perfusion is likely from re-entry tear(s) along the zdes stent in the distal taa.¿ a query to the imaging reviewer was placed requesting whether the re-entry tears along the first zdes stent are caused by/related to the stent or if they were present before the stent was implanted.The imaging reviewer responded ¿there were re-entry tears at the distal ta prior to the implant, nothing to suggest any new stent related tears from this imaging¿.Based on the findings in the imaging review no endoleak or new re-entry tears in relation to the complaint device were found and therefore, the complaint is unconfirmed.In addition, it is noted that the patient was treated with at zta device in the second intervention which is off-label as dissection is outside the intended use for zta devices.Cook will reopen the investigation if further information is received.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 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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 12932291
• MDR Text Key: 281736832
• Report Number: 3002808486-2021-02001
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002242767
• UDI-Public: (01)10827002242767(17)230921(10)E4019227
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2023
• Device Catalogue Number: ZDEG-P-32-202-PF
• Device Lot Number: E4019227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2020
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG