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-40-164-PF

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/17/2021

Event Type  Injury  

Event Description

Description of event according to study: migration of both zdeg devices on 6 month ct.On (b)(6) 2021 during the index procedure, a zdeg-p-40-164-pf (lot# e3953000) and a zdeg-p-40-164-pf (lot#e4006963) were implanted without difficulty.The degree of oversizing was not reported on either device.No other devices were placed.Primary indication for implant was an aortic dissection (diagnosed (b)(6) 2020.The primary tear was the descending aorta, distal to left subclavian.The proximal location of the dissection was within the descending aorta, distal to left subclavian.Distal location was the left common iliac.There were no secondary or re-entry tears.The proximal seal zone tortuosity, occlusive disease, and calcification were unable to be assessed.There was no thrombus present.The proximal location of the graft was reported as zone 3.The left subclavian artery not completely covered by the graft fabric.A balloon was used on the graft during the procedure (information about the balloon was not collected) at the proximal sealing zone of the graft to facilitate anatomic compliance.Information on location of the balloon is not available at this time.The study devices were patent without device integrity issues at the end of the procedure.The thoracic and abdominal false lumens were partially thrombosed with blood flow from a type ia endoleak through the primary tear (previously reported pr348859 manufacturer ref#3002808486-2021-02006).The patient was discharged on (b)(6) 2021.On (b)(6) 2021 (35 days post-procedure), a follow-up ct was completed.There was no progression/growth of the dissection or development of a new entry tear.The thoracic and abdominal false lumens were partially thrombosed with blood flow through the primary tear due to a type ia endoleak.The study devices were patent without evidence of migration or device integrity issues.On (b)(6) 2021 (48 days post-procedure), a follow-up ct was completed.There was no progression/growth of the dissection or development of a new entry tear.A type ia (proximal) endoleak was reported.The thoracic false lumen was patent, and the abdominal false lumen was completely thrombosed.The study devices were patent without evidence of migration or device integrity issues.On (b)(6)2021 (50 days post-procedure) patient underwent a successful surgical ascending aorta replacement due to a pre-existing aortic aneurysm.On (b)(6) 2021 (198 days post-procedure), a non-contrast follow-up ct was completed.There was evidence of >10mm caudal migration reported of both grafts.The information given states ¿migration of both devices due to a malposition in the aortic arch.Despite that, false lumen is thrombosed at 6 months.¿ other measurements and perfusion of the false lumen were not assessed.No separation of devices or device integrity issues reported.On (b)(6) 2021 (321 days post-procedure) a follow-up ct was completed.There was no progression/growth of the dissection or development of a new entry tear.The thoracic and abdominal false lumens were partially thrombosed with blood flow through the primary tear due to type ia endoleak.The study devices were patent without evidence of migration or device integrity issues.Patient outcome: no plans for a secondary intervention related to the migration have been reported.

Manufacturer Narrative

Manufacturer ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.G4) similar to device under pma 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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: on (b)(6) 2021 during the index procedure, a zdeg-p-40-164-pf (complaint device 1) and a zdeg-p-40-164-pf (complaint device 2) were implanted without difficulty.The degree of oversizing was not reported on either device.No other devices were placed.Primary indication for implant was an aortic dissection (diagnosed (b)(6) 2020).The primary tear was the descending aorta, distal to left subclavian.The proximal location of the dissection was within the descending aorta, distal to left subclavian.Distal location was the left common iliac.There were no secondary or re-entry tears.The proximal seal zone tortuosity, occlusive disease, and calcification were unable to be assessed.There was no thrombus present.The proximal location of the graft was reported as zone 3.The left subclavian artery not completely covered by the graft fabric.A balloon was used on the graft during the procedure (information about the balloon was not collected) at the proximal sealing zone of the graft to facilitate anatomic compliance.Information on location of the balloon is not available at this time.The study devices were patent without device integrity issues at the end of the procedure.The thoracic and abdominal false lumens were partially thrombosed with blood flow from a type ia endoleak through the primary tear (related complaint).The patient was discharged on (b)(6) 2021.On (b)(6) 2021 (35 days post-procedure), a follow-up ct was completed.There was no progression/growth of the dissection or development of a new entry tear.The thoracic and abdominal false lumens were partially thrombosed with blood flow through the primary tear due to a type ia endoleak.The study devices were patent without evidence of migration or device integrity issues.On (b)(6) 2021 (48 days post-procedure), a follow-up ct was completed.There was no progression/growth of the dissection or development of a new entry tear.A type ia (proximal) endoleak was reported.The thoracic false lumen was patent, and the abdominal false lumen was completely thrombosed.The study devices were patent without evidence of migration or device integrity issues.On (b)(6) 2021 (50 days post-procedure) patient underwent a successful surgical ascending aorta replacement due to a pre-existing aortic aneurysm.On (b)(6) 2021 (198 days post-procedure), a non-contrast follow-up ct was completed.There was evidence of >10mm caudal migration reported of both grafts.The information given states ¿migration of both devices due to a malposition in the aortic arch.Despite that, false lumen is thrombosed at 6 months.¿ (current complaint) other measurements and perfusion of the false lumen were not assessed.No separation of devices or device integrity issues reported.On (b)(6) 2021 (321 days post-procedure) a follow-up ct was completed.There was no progression/growth of the dissection or development of a new entry tear.The thoracic and abdominal false lumens were partially thrombosed with blood flow through the primary tear due to type ia endoleak.The study devices were patent without evidence of migration or device integrity issues.Several attempts to obtain additional information concerning if images are available, proximal/distal fixation length, elaboration of event, if the surgical ascending aorta replacement affected the position of the two zdeg devices and if the migration was still present on 13dec2021.No further information was provided for investigation.Current complaint relates to the migration of zdeg devices discovered 198 days post-procedure.Review of the device history record gave no indication of either device being produced out of specification.No images were provided for investigation.Based on provided information, it is not possible to establish the cause of the reported migration of two zdeg devices.It is possible that the surgical replacement of the ascending aorta prior to the observed migration have altered the anatomy at the proximal sealing zone hereby facilitating migration of the device as suggested by the information ¿migration of both devices due to malposition in the aortic arch¿.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.

Event Description

Additional information received 15sep2023: no further migration was noted, compared to a intra procedure migration.The false lumen is completely thrombosed in the thoracic portion of the aorta in the angioscan of (b)(6) 2021, 4 months post op, which is an excellent result despite a real suboptimal placement of the 2 modules.No other endovascular procedure was performed.Open surgical replacement of the segment 1 of the ascending aorta was performed on (b)(6) 2021.

Manufacturer Narrative

Manufacturers ref#(b)(4).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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: per additional information provided, the migration happened during the index procedure: ¿during the procedure, the surgeon placed a first module behind the subclavian artery.False lumen perfused on the intermediate angiogram control.Decision to place a second module right behind the left carotid.Good initial placement but still a perfusion in the false lumen.So decision the inflate the more proximal module with a compliant balloon.During this second maneuver, there is a migration of this second module in the aortic isthmus.Decision by the surgeon to stay in this situation, knowing result would be sub optimal.¿ furthermore, ¿¿no further migration was noted, compared to a intra procedure migration.The false lumen is completely thrombosed in the thoracic portion of the aorta in the angioscan of (b)(6) 2021 4 months post op, which is an excellent result despite a real suboptimal placement of the 2 modules.No other endovascular procedure was performed.¿ based on the compiled information, this complaint regards inadequate proximal seal causing continuing false lumen perfusion / type 1a endoleak after placement of the second (b)(4) (complaint device), which during ballooning also migrated.A related complaint ((b)(4) manufacturer ref# (b)(4) regards the type 1a endoleak discovered after placement of the first zdeg-p-40-164-pf.Procedural angio from the index procedure (26jan2021) and cta post op (02mar2021) were received for investigation.Based on provided images, a imaging review has been performed by an imaging expert.Per imaging review findings: ¿initial aortogram shows a type 2 arch with a linear defect down the descending ta (thoracic aorta) consistent with a dissection flap.The first zdeg (p-40-164) graft is placed with the proximal edge immediately distal to the lsa (left subclavian artery) origin.The graft is significantly compressed past the proximal graft edge within the true lumen.There is continued false lumen flow around the proximal graft.On subsequent view, the proximal graft now appears to land obliquely further away from the lsa with a bird-beak appearance along the lesser curve.An additional zdeg (p-40-164, complaint device) graft is placed for proximal extension and appears to partially cover the lsa.On the next view, however, the proximal extension zdeg now appears to land just distal to the lsa, again in an oblique fashion without circumferential graft wall apposition at the lsa.The proximal graft extends the bird-beak appearance from the 1st graft.¿ based on the imaging review findings, the imaging expert impressions are "the type 1a endoleak and lack of adequate proximal seal is due to tortuosity of the aortic arch and proximal landing zone.There is a significant anterior curvature of the arch along with type 2 anatomy.The proximal zdeg lands within this curvature, resulting in an oblique position of the proximal edge with the posterior graft deflecting away from the aortic wall"."intraoperative migration.Is likely related to balloon molding the proximal grafts to conform to the anterior tortuosity resulting in the proximal grafts expanding in an oblique position further distal to the lsa than initially planned"."the tortuosity of the arch and the oblique landing of the proximal zdeg grafts after balloon molding complicates the perceived position of the proximal grafts and may have been misinterpreted as intraoperative migration." furthermore, based on additional queries ¿¿there is a 62-degree angulation (anterior bend) at the mid arch and another 40-degree counter angulation at the distal arch/proximal descending ta.The proximal landing zone is right at the mid arch angulation.This angulation falls outside the ifu (instructions for use).¿ review of the device history record gave no indication of the device being produced out of specification.Per ifu, ¿the zenith tx2 dissection endovascular graft with pro-form and the z-trak plus introduction system is indicated for the endovascular treatment of patients with symptomatic dissection of the descending thoracic aorta having vascular morphology suitable for endovascular repair (fig.4), including: ¿ ¿with localized angulation less than 45 degrees.¿ based on provided information and imaging review, the likely cause for the inadequate proximal sealing of the zdeg-p-40-164-pf is tortuosity in the proximal landing zone causing the device to deploy with a bird-beaking appearance.During balloon molding the device conform to the tortuosity of the landing zone, which might have been misinterpreted as interoperative migration.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 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 4632 ; DA 4632
• Manufacturer Contact: henriette s. christiansen ; sandet 6, dk-4632; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 17008351
• MDR Text Key: 315992547
• Report Number: 3002808486-2023-00156
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002242897
• UDI-Public: (01)10827002242897(17)230218(10)E3953000
• 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,Study,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2023

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: 02/18/2023
• Device Catalogue Number: ZDEG-P-40-164-PF
• Device Lot Number: E3953000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 09/06/2023; 09/15/2023; 11/23/2023
• Supplement Dates FDA Received: 09/18/2023; 09/22/2023; 12/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2020
• 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): Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 21 KG