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-36-161-W1

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)

Event Date 09/27/2023

Event Type  Death  

Manufacturer Narrative

Manufacturer ref#: (b)(4).G4) similar device registered under: (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

Description of event according to initial reporter: patient anatomy before surgery and at the time of failure: a distal anastomotic aortic aneurysm after tar (total arch replacement).Because of a tortuosity in the aorta, the plan was to switch to a through and through guidewire technique if delivery was difficult with lunderquist.There were no problems with access, and dryseal 22fr (introducer sheath from another manufacturer) was used from the beginning because two stent grafts were to be used and replacement would occur.Plan: piling up 2 stent grafts: zta-p-30-155-w1--- approached from the right for distal deployment.Zta-p-36-161-w1--- approached from the right for proximal deployment.Device delivery was to be done by lunderquist.Zta-p-30-155-w1 was deployed at the planned location with delivery of the descending aortic flexure as the distal.The proximal device, zta-p-36-161-w1, lot: e4136923, was scheduled to be deployed beyond the distal anastomotic aortic aneurysm, just below the left subclavian artery.However, when the user attempted delivery of zta-p-36-161-w1 just below the left subclavian artery, the delivery system failed to pass through the distal anastomotic aortic aneurysm.Since this was probably due to the tortuosity, the wire guide was changed to the through and through guidewire technique as per the preoperative surgical plan.After changing the wire guide to the through and through guidewire technique, another attempt was made to deliver zta-p-36-161-w1, but the delivery system did not pass through.(the user tried several times while adjusting the force of the wire.) after all, the delivery system did not pass through the distal anastomotic aortic aneurysm, and it was decided to remove the delivery system, however the stent graft was deployed in the dryseal.(the reason why it was deployed in the dryseal is unknown.) it was difficult to remove the entire dryseal, which was thought to be due to the barb penetrating the dryseal, so the entire dryseal and the implanted stent graft were removed by laparotomy.(zta-p-36-161-w1 was not deployed in patient's body.) when the stent graft was removed, it was discovered that the dilator tip and delivery system had separated and the delivery system had been damaged.Another zta-p-36-161-w1, lot: e4400205 was delivered almost to the target site using the through and through guidewire technique.However, when the user started unsheathing, a snapping sound occurred halfway through.He continued to unsheathe, but the sheath did not come down and the delivery system and the base of the valve appeared to be stretched.Because the sheath with the blades had probably stretched, resulting in poor deployment, the delivery system was retrieved.(zta-p-36-161-w1 was also not deployed in patient's body.) the surgery was cancelled due to consecutive zta-p-36-161-w1 trouble.The additional procedure could not be performed and treatment was not completed as scheduled.It has been scheduled to change the device and try tevar again at a later date.When the wire guide was changed to the through and through guidewire technique, the delivery system was withdrawn from the patient.Patient outome: the entire dryseal and the implanted stent graft were removed by laparotomy.The surgery was cancelled due to consecutive zta-p-36-161-w1 trouble.The additional procedure could not be performed and treatment was not completed as scheduled.

Event Description

Patient outcome: it was reported by the sales rep in charge that the patient had died of cardiovascular failure after surgery.The surgeon in charge does not consider the cause of death has something to do with the devices used.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: an 87-year old male patient underwent tevar (thoracic endovascular aortic repair) for an aortic aneurysm distal to the anastomose after a tar (total arch replacement (unknown date)).The plan was to implant zta-p-30-155-w1 approached from the right for distal deployment and a zta-p-36-161-w1(complaint device) approached from the right for proximal deployment.Device delivery was to be done by lunderquist, but because of the tortuosity in the aorta, the plan was to switch to a through and through guidewire technique if delivery was difficult with lunderquist.There were no problems with access, and gore's dryseal 22fr (introducer sheath) was used.Zta-p-30-155-w1 was deployed at the planned location as the distal device.The proximal device, zta-p-36-161-w1 (complaint device), was to be deployed beyond the distal anastomotic aortic aneurysm, just below the left subclavian artery (lsa).However, when the user attempted delivery of zta-p-36-161-w1(complaint device) just below the lsa, the delivery system failed to pass through the distal anastomotic aortic aneurysm.It was reported that this was probably due to the tortuosity, so the delivery system was withdrawn from the patient and the wire guide was changed to the through and through guidewire technique.Despite changing to the through and through guidewire technique, several attempts were made to deliver zta-p-36-161-w1 (complaint device), but the delivery system did not pass through (current complaint).It was then decided to remove the delivery system.During attempted delivery system removal, the stent graft deployed in the dryseal gore sheath.The entire dryseal gore sheath was difficult to remove.It was suspected to be due to the barb penetrating the dryseal gore sheath.The entire dryseal sheath and the implanted stent graft was removed by laparotomy, and the damaged area was repaired.When the stent graft was removed, it was discovered that the dilator tip and delivery system had separated and the delivery system had been damaged.Per the additional information, it was reported that the delivery system was not scrutinize closely before use, but the user doubt they would have used the device if there was a visibly noticeable level of damage.The user suspected the possibility of a manufacturing error in the device due to a damaged point that would not normally break away (related complaint).Another zta-p-36-161-w1 was delivered almost to the target site using the through and through guidewire technique.However, when the user started unsheathing, it was reported that a snapping sound occurred halfway through.The user continued to unsheathe, but the sheath did not come down and the delivery system and the base of the valve appeared to be stretched (related complaint).The device was not deployed and delivery system was then retrieved.Due to the consecutive zta-p-36-161-w1 trouble the procedure was cancelled.The additional procedure could not be performed and treatment was not completed as scheduled.It was scheduled to change the device and try tevar again at a later date.It was reported that the patient had died of cardiovascular failure after surgery.The surgeon in charge does not consider the cause of death has something to do with the devices used.Review of the device history record gave no indication of the device being produced out of specification.The zta-p-36-161-w1 device was returned in several parts.No shipping stylet was returned.Two unknown wire guides were returned (not wce wire guides).Device evaluation was performed.Per the device evaluation the gray positioner and sheath were curvy.The cause was possibly that the device was returned rolled up in a shipping box.The sheath had several kinks, wrinkles and long scratches along the length and the sheath tip was deformed with indentations.These observations could have been caused during advancement and retrieval in the patient¿s tortuous anatomy.If the sheath was used to push the stent graft after its attachment in the dryseal sheath this could have caused the damage to the sheath tip.The blue rotation handle had been rotated to stop indicating that the trigger wires had released the stent graft at some point during the procedure.The stent graft was returned in two pieces.The proximal part with bare alignment stent and first stent with barbs had been cut from the distal part of the stent graft.The cut was possibly performed during laparotomy.An imaging review of the provided planning and sizing worksheet with a 3-d reconstructions of the ascending aorta, arch prosthesis, and descending thoracic aorta were performed by an imaging expert.Per the findings in the image review: ¿the thoracic aorta was severely tortuous one greater than 90-degree kink at the diaphragm and a second at the mid descending thoracic aorta.The replaced arch was elongated and exaggerated.The distal arch prosthesis was ovoid near the anastomosis likely indicating an additional kink or stenosis at the anastomosis.Additional tortuosity was present in the severely tortuous right iliac arteries and moderately tortuous abdominal aorta.An overlay of the planning and sizing line drawing and 3d reconstruction illustrates the contrast between the typically anatomy of a thoracic aortic aneurysm and the exaggerated anatomy created by the arch prosthesis and the additional descending thoracic kinks.A through and through wire would have held the introducer tip along the outer posterior curvature of the thoracic aorta, anastomosis, and the arch prosthesis.To reach the desired proximal landing zone just distal the lsa branch origin, the introducer tip would have needed to reach at least the ia branch origin.The depth and position of the proximal landing zone was more consistent with ascending aortic or aortic valve target.¿ per the impression in the image review: "the complaint was likely given the severely tortuous anatomy, a narrowed or kinked distal arch prosthesis anastomosis, and the deep proximal landing zone.Although the ifu allows implantation up to a native left common carotid artery (lcca), prosthetic arch lcca or lsa branches are not equivalent.Prosthetic arch branches are located more anterior and closer to the aortic root.Reaching these prosthetic branch landing zones requires an insertion depth equivalent to the ascending aorta or aortic valve.¿ furthermore, a clinical assessment was performed by medical advisor.Per the clinical assessment: ¿the sheath and sheath tip had deformations that could indicate a difficult advancement and difficult advancement had been anticipated by the physician due to tortuous anatomy.Based on the information the physician did not consider the death to be caused by the devices used.However, the close time wise relation with the planned (but unsuccessful) tevar and resulting prolonged and open procedure cannot be rule out to have played a role.However, it cannot be concluded that the first device was faulty why the patient death is suggested to be regarded as procedure-related.It is noted that two zta-p were planned used (recommendation in ifu is to use a zta-p and a zta-d).However, it is assessed irrelevant for the difficulties and outcome.¿ it is reported that the patient had tortuous anatomy which is supported with the image review of the provided 3-d reconstructions of the aorta that shows there was severe tortuosity in the thoracic aorta and right iliac arteries and the replaced arch was elongated and exaggerated.According to the instruction for use ¿do not continue advancing the wire guide or any portion of the introduction system if resistance is felt.Stop and assess the cause of resistance; vessel, catheter, or graft damage may occur.Exercise particular care in areas of stenosis, intravascular thrombosis, or calcified or tortuous vessels.¿ based on the provided information, device evaluation, image review and clinical assessment the advancement difficulties is likely due to the severely tortuous anatomy, the narrowed or kinked distal arch prosthesis anastomosis, and the deep proximal landing zone.In addition it is noted that two zta-p were planned to be used combined and according to the ifu ¿zenith alpha thoracic endovascular graft the zenith alpha thoracic endovascular graft is a two-piece cylindrical endovascular graft consisting of proximal and distal components.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.

• 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: alex rahbek ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 17875149
• MDR Text Key: 324960808
• Report Number: 3002808486-2023-00253
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002449586
• UDI-Public: (01)10827002449586(17)240715(10)E4136923
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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-36-161-W1
• Device Lot Number: E4136923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 01/29/2024
• Supplement Dates FDA Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2021
• 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): Death; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male