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

Catalog Number ZDEG-PT-34-159-PF

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

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

Event Date 02/01/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device under pma/510(k) p180001.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

Description of event according to study: on (b)(6) 2020 during the index procedure, a zdeg-pt-34-159-pf (lot# e3952445) was implanted without difficulty.The degree of oversizing was not reported.A molding balloon was not used during the procedure.No other devices were placed.Primary indication for implant was as a proximal extension to a zta initially used to treat a penetrating aortic ulcer.The proximal edge if the graft fabric was in zone 3 but the graft fabric did not cover the left subclavian artery.The device was patent without device integrity issues at the end of the procedure.The patient was discharged on (b)(6) 2020.A ct dated (b)(6) 2020 revealed the device was patent with no endoleak or device integrity issues.This ct also revealed a new pau ¿downstream of the left subclavian¿ that was treated (b)(6) 2020 with placement of a zdeg-p-30-142-pf (lot# e3855219).Query in place to determine if proximal or distal to originally placed zdeg.A ct dated (b)(6) 2021 revealed a type i distal endoleak of the zdeg as well as a type ii endoleak.No other device issues were identified.On (b)(6) 2022 the patient had a zta-p-32-201 implanted to overlap between the 2 implanted zdeg devices to treat a type iii endoleak as well as the type ib endoleak.A ct dated (b)(6) 2022 revealed only the type ii endoleak.

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: on 02oct2020 during the index procedure, a zdeg-pt-34-159-pf (complaint device) was implanted without difficulty.The degree of oversizing was not reported.A molding balloon was not used during the procedure.No other devices were placed.Primary indication for implant was as a proximal extension to a zta initially used to treat a penetrating aortic ulcer (pau).Details on the proximal landing zone were asked but were marked as not known.The proximal edge of the graft fabric was in zone 3 but the graft fabric did not cover the left subclavian artery.The device was patent without device integrity issues at the end of the procedure.The patient was discharged on (b)(6) 2020.A ct dated (b)(6) 2020 revealed the device was patent with no endoleak or device integrity issues.This ct also revealed a new pau ¿downstream of the left subclavian¿ that was treated (b)(6) 2020 with placement of a zdeg-p-30-142-pf, which was implanted proximally to zdeg-pt-34-159-pf.Per the reported information, the new pau was in the aortic arch.A ct dated (b)(6) 2021 revealed a type 1b endoleak of the zdeg as well as a type 2 endoleak.No other device issues were identified.Per the last reported information this type 1b endoleak (b)(4) refers to the zta-p-28-109 and not to the zdeg.On 01feb2022 the patient had a zta-p-32-201 implanted to overlap between the 2 implanted zdeg devices to treat a type 3a endoleak as well as the type 1b endoleak.A ct dated (b)(6) 2022 revealed only a type 2 endoleak.No other device issues were identified.Due to the received information, it is assumed that a type 2 endoleak refers to one of the two implanted zdeg devices (b)(4).This complaint addresses a type 3a endoleak.Review of the device history record gave no indication of the device being produced out of specification.Endoleak is listed as a potential adverse event in the instructions for use.No imaging was provided for investigation.Based on the limited provided information it has not been possible to determine the cause of the reported event.Cook will reopen this complaint if additional information is received.It is noted that zdeg device is used in combination with zta, which is outside of intended use.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 DISSECTION ENDOVASCULAR GRAFT TAPERED 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: 15549157
• MDR Text Key: 301237678
• Report Number: 3002808486-2022-00968
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002242583
• UDI-Public: (01)10827002242583(17)220924(10)E3952445
• 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: 02/15/2023

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: 09/24/2022
• Device Catalogue Number: ZDEG-PT-34-159-PF
• Device Lot Number: E3952445
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 02/10/2023
• Supplement Dates FDA Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2019
• 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 Sex: Female
• Patient Weight: 55 KG