MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-P-30-155-W1

Device Problems Off-Label Use (1494); Mechanical Jam (2983); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2023

Event Type  malfunction  

Event Description

Description according to initial reporter: a 41-year-old male patient with type b dissection was transported to the hospital.As the patient was complaining of abdominal pain, emergency thoracic endovascular aortic repair (tevar) was performed after 1 debranching, after securing the true lumen by performing intravascular ultrasound (ivus), a zta-p-30-155-w1 was advanced and the stent graft was deployed at zone 2.When deploying 2 stents, it was pushed hard by blood flow to around zone 3.The zta-p-30-155-w1 was advanced adjusting to zone 2 and continued the deployment.Fluoroscopically, the stent graft was deployed successfully.Then, the first gzsd-36-164-2 was advanced and placed in the descending aorta.After confirming the distal side was placed more proximally than the celiac, the stent graft was deployed, and the deployment looked successful fluoroscopically.And then, the second gzsd-36-164-2 was advanced and placed in the abdominal aorta.After confirming the distal side was not over the terminal aorta, the stent graft was deployed.At that time, stents of the 4th to 8th stents from the proximal side did not look quite deployed properly (it looked that the stent graft did not deploy properly at around just after the distal end of the fist gzsd-36-164-2; big gap between the first gzsd-36-164-2 and the second gzsd-36-164-2).When the final angiography was performed, the celiac and the bilateral renal arteries in the abdominal branching vessels were visualized, but the superior mesenteric artery (sma) was not.Cannulation was attempted but failed.At this point it was confirmed that there were no abnormalities in the patient's biometric data.Therefore, the physician finished the tevar, and ct angiography was performed in the ct room.From the result of the ct angiography, the stent grafts of the zta-p-30-155-w1 and the first gzsd-36-164-2 looked deployed properly.But the stent graft of the second gzsd-36-164-2 looked deployed poorly compared to the first one.(hardly any false lumens were seen in the location where the zta-p-30-155-w1 and the first gzsd-36-164-2 were placed, but there was space that looked like a false lumen in the location where the second gzsd-36-164-2 was placed.) also, the sma was visualized in the collateral blood vessels, but the origin of the sma from the abdominal aorta looked occluded.So, there is a possibility that it was occluded regardless of the tevar because it was branched out from where the true lumen collapsed before the tevar.In any case, it was decided to perform an open bypass.In addition, areas where the true lumen was not visualized were noticed at around the terminal aorta although the range is not large.Based on the result of the cta, an open bypass was performed for the sma right after the tevar.The right external iliac artery (eia) and the sma were bypassed, and it was confirmed that the haemodynamics has improved.The abdominal aorta was not touched in this surgery.Post-operative examination also confirmed that the patient's vitals showed no abnormalities.The patient will be discharged after a follow-up.A follow-up ct for this surgery is scheduled in two weeks.Since the second gzsd-36-164-2 had expanding defect, the device may have an inner membrane wrapped around it.It seems that a false lumen remained around the area in result.Also, as can been seen by the fact that the area around the terminal aorta could not been depicted by cta after the tevar, it was suggested that inner membrane could retain at around the distal side of the abdominal aorta, but this was within their expectations as they have not been visually verified.For both lower legs, no measures have been taken as the blood flow from the remaining false lumen is maintained.As for this event, since the tevar was performed as an emergency case for acute dissection, the inner membrane was expected to have been very fragile.At this point, this case is finished because the patient recovered by performing the sma bypass.

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device under pma/510(k) p140016.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

Manufacturers ref# (b)(4).Summary of investigational findings: a 41-year-old male patient with type b dissection was complaining of abdominal pain.Therefore, an emergency thoracic endo vascular aortic repair (tevar) was performed.The subclavian artery was first debranched and then a wireguide was advance into the patient.Intravascular ultrasound (ivus) was performed to confirm that the wire guide was in the true lumen to advance the delivery system.A zta-p-30-155-w1 (complaint device) was advanced, and the stent graft was deployed at zone 2.When two stents (including barbs) was deployed, it was then pushed down hard by blood flow to around zone 3.The zta device was then pushed forward again (re-advanced) to land the device in the planned target zone 2.The deployment continued and with fluoroscopy it was confirmed that the stent graft was deployed successfully.Then, the first gzsd-36-164-2 was advanced and placed in the descending aorta.After confirming the distal side was placed more proximally than the celiac, the stent graft was deployed, and the deployment looked successful fluoroscopically.Then, the second gzsd-36-164-2 was advanced and placed in the abdominal aorta.After confirming the distal side was not over the terminal aorta, the stent graft was deployed.It was reported that stents of the 4th to 8th stents from the proximal side did not look deployed properly (just after the distal end of the fist gzsd).In the final angiography, the superior mesenteric artery (sma) was not visualized.Cannulation was attempted but failed.No abnormalities in the patient's biometric data was reported.Therefore, the physician finished the tevar and ct angiography was performed.From the ct angiography, it was observed that the stent grafts of the zta-p-30-155-w1 and the first gzsd-36-164-2 looked deployed properly.But the stent graft of the second gzsd-36-164-2 looked deployed poorly compared to the first one.Also from the cta, the sma was visualized in the collateral blood vessels and looked occluded (pr386216).Based on the result of the cta, an open bypass was performed for the sma right after the tevar.The abdominal aorta was maintained, but the right external iliac artery (eia) and the sma were bypassed, and it was confirmed that the haemodynamics had improved.Post-operative examination also confirmed that the patient's vitals showed no abnormalities.It was reported that the case is finished because the patient recovered by performing the sma bypass and will be discharged after a ct follow-up.The physician suspected the possibility of intimal damage (intra-aortic abnormality) because the sma was not contrasted on the final angiography.He comments that as an emergency case for acute dissection, the inner membrane was expected to have been very fragile.In regards to the complaint device he suspects that intimal damage could have occurred due to stress on the inner membrane when advancing the zta-p-30-155-w1 (complaint device), due to push-up after the zta-p-30-155-w1 (complaint device) deployment or caused by distal stent induced new entery tear (sine) with the distal sealing stent after the zta-p-30-155-w1 deployment.However, no signs of this was seen as it was just the physician¿s guessing after assuming various cases.Review of the device history record gave no indication of the device being produced out of specification.The device was not returned.Four preop ct studies, an angiography procedure, and 2 postoperative ct studies were provided and imaging review has been performed by an imaging expert.Per the findings in the imaging review: ¿there is a type b aortic dissection that begins just distal to the left subclavian artery (lsa) with the primary entry tear about 20 mm from the lsa.The proximal aortic diameter is 29 x 28 mm at the left common cartoid artery (lcca), and the distal diameter is 28 x 32 mm at the celiac trunk.The zta (p-30-155) graft is deployed immediately distal to the lcca and appears fully expanded.The zta is well expanded in the true lumen to a 29 mm diameter.A re-entry tear at the distal edge of the 1st gzsd stent likely perfuses the false lumen around the 2nd gzsd stent¿.Furthermore, the image reviewer comments: ¿the description of the zta jumping forward on deployment and successfully advancing back to the target landing zone was likely just from antegrade blood pressure during deployment and probably not enough forward pressure on the device during deployment.This isn't seen on the angio.The device was in good proximal position on deployment on the images provided.The re-entry tear causing compression of the 2nd gzsd is well away from the zta graft so unlikely a sine from the distal zta, but stress on the dissected intima (distally) during manipulation of the zta graft is possible but can't be confirmed as the cause of the distal tear.I agree with the operator that the dissected intima is very fragile in the acute setting so a tear during device manipulation is always a possibility.But the more likely cause is a re-entry tear at the distal (1st) gzsd during deployment of this stent and unrelated to the zta.Nothing indicates that the event is related to a fault condition of the device, the event is assessed as an adverse effect inherent to this type of procedure why the event is assessed to be a side effect.Furthermore, per the instructions for use the safety and effectiveness of the zenith alpha thoracic endovascular graft and ancillary components have not been evaluated in patients having dissections.It is noted that the zta device is used for treatment of dissection 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS
• 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: lissi walmann ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 16270148
• MDR Text Key: 308442206
• Report Number: 3002808486-2023-00034
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449463
• UDI-Public: (01)10827002449463(17)251213(10)E4345294
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2023

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 Catalogue Number: ZTA-P-30-155-W1
• Device Lot Number: E4345294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 01/31/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2022
• 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: 41 YR
• Patient Sex: Male