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-40-217

Device Problems Improper or Incorrect Procedure or Method (2017); Mechanical Jam (2983)

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

Event Date 12/22/2022

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Protocol#: similar to device marketed under pma/510(k): p140016.Investigation is still in progress.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

Description of event according to initial reporter: after delays in getting the procedure started due to a second active bleeding rupture requiring treatment, the procedure started at approx.12:45, with the same staff.There were difficulties with the surgical bypass anastomoses and it took time before the endovascular procedure could be begun.This part begun at approx.16:30 with percutaneous access on the right groin, a 300cm lunderquist wire was advanced to the arch and the first proximal device was positioned after completion of some angiograms to ascertain the precise origin of the left common carotid and brachiocephalic arteries.The device was positioned precisely and the anaesthetic team attempted to lowered the blood pressure medically but the patient barely responded.As the blood pressure got a bit lower the deployment began and as the zta-pt-44-40-233 was deployed the device windsocked backwards out of position leaving the proximal seal shorter than ideal, they attempted to move the device forward to a more ideal position but it moved a little but not enough.The device was deployed in this location and it was decided to use a second device to improve the proximal seal by extending beyond the original graft, as such a zta-pt-44-40-179 was introduced and deployed precisely to create the necessary proximal seal (approximately 30mm and a full extension beyond the previous location).A third device the zta-p-40-217 was then sized for overlap and distal sealing above the coeliac artery.The overlap between the grafts was viewed and accepted and whilst in a lateral position and under magnification the third device was deployed landing precisely above the coeliac artery origin.At his point it was attempted whilst still under magnification and without the visibility of the proximal end to remove the delivery system.Unfortunately the wires were still attached and this resulted in the graft being pulled down covering the coeliac and sma.It is noted that at this point it was approx.18:30.To attempt to move the distal graft back into position a second 260cm lunderquist wire was introduced and a large dryseal sheath into the left groin to allow a coda 46 balloon to be advance over the wire inside the third graft to be inflated and the device and the balloon pushed back up into position whilst the wires were still attached to the device delivery system.Some movement at the distal end was observed and some at the proximal end, but not what was desired.This method was tried a few more times and then as it wasn¿t achieving the desired results it was decided to release the device in its currently location as the digital end was facing the coeliac an sma origins, we could then use the longer delivery system sheath with the coda 46mm balloon to support the balloon and push the distal end up utilising the fabric gaps to allow some compression of the device, however prior to doing that it was decided as we had access to the sma to place a 260cm rosen wire and 7fr checkflo hfanl1 sheath into the sma, with the consensus that the dissected coeliac could be sacrificed if necessary but a periscope stent could be place into the sma to preserve that if necessary.The zta-p-40-217 was then released when this was achieved and the distal end of the graft didn¿t move.The large delivery sheath was then advanced via the right groin inside the third component and using the coda balloon inflated above the sheath and supported by the sheath it was pushed forward in another attempt to push the distal end of the graft back into its desire location, this was performed in increments along the distal segment of the graft and the distal end did appear to relocate a little more but not enough as it now appeared wedge on the anterior wall in the ostium of the coeliac artery, but it looked as though the distal stent was still pointing at the anterior wall, however it appeared to look a little malformed.It was decided to do a run and see what things looked like there was flow into both renals, the sma and the coeliac, at this point it was decided that nothing else could be done to improve the position of the graft and that as all of the vessels were filling in a normal manner, and the graft wasn¿t moving to withdraw and allow the patient to recover.Upon further examination of the final angiograms and the series taken through the case, it looks as though the initial pulling of the graft with the ties still in position and pushing may have partially separated the final stent on the posterior segment of the aorta away from the graft material, as the malformation of the stent and its markers suggest the anterior portion is in the original location, this coupled with the undisturbed contrast flow around that stent suggest that the fabric of the graft is open and not indeed across the aorta as there was no disturbance in the contrast flow on the angiogram as would be expected if the graft were filling before the aorta.Subsequently at approx 20:00 the anaesthetic team awakened the patient and he was observed to be moving both feet and not in any discomfort at that time, as this was another concern due to the coverage of such a large segment of the descending thoracic aorta.In addition to this i have also heard from the clinical team this morning as to the current prognosis, the patient is being held in hospital under observation as was planned, and other wise is alive and well, and able to move his limbs.Patient outcome: the whole device remains insitu, and the distal stent is still partially attached and secure, if this changes then that part will be retrieved.Patient will receive follow up cta's as normal.

Event Description

Additional information received 17feb2023: debranched left subclavian artery with surgical crossover to the left common carotid artery, to create a sealing area up to the left common carotid artery.Final location of the device was approx.10 to 15mm distal to the intended proximal sealing area, hence the use of a proximal extension.

Manufacturer Narrative

Manufacturers ref# (b)(4).Investigation is still in progress.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

Manufacturers ref# (b)(4) summary of investigational findings: the male patient with a dissection underwent an urgent treatment including a subclavian carotid bypass and an endovascular procedure.The dissection was located approx.10mm distal to the left subclavian artery (lsa) origin, and throughout the descending thoracic aorta.A zta-pt-44-40-233 was deployed.The device was pushed by blood pressure backwards out of position leaving the proximal seal shorter than ideal (pr(b)(4), mhra ref# 2023/006/007/601/017).The second device to improve the proximal seal by extending beyond the original graft, as such a zta-pt-44-40-179 was introduced and deployed precisely to create the necessary proximal seal (approximately 30mm and a full extension beyond the previous location).A third device the zta-p-40-217 (complaint device) was then sized for overlap and distal sealing above the coeliac artery.The wires were still attached, and this resulted in the graft being pulled down covering the coeliac and superior mesenteric artery (sma).Per the reported information, there were no problem with the device, but it was a human error.The ballooning was performed few times to push the stent graft back, whilst the wires were still attached to the delivery system.It was decided to release the device in its currently location as the digital end was facing the coeliac an sma origins.The wires were released from the introduction system in the normal manner using the rotation handle.It was attempted to pull and push the zta-p-40-217 in a desirable location by advancing the large sheath from another manufacturer was via the right groin inside the third component and using the coda balloon inflated above the sheath.The distal end did appear to relocate a little more but not enough as it now appeared wedge on the anterior wall in the ostium of the coeliac artery, but it looked as though the distal stent was still pointing at the anterior wall, however it appeared to look a little malformed.However, there was flow into both renal arteries, the sma and the coeliac and at this point it was decided that nothing else could be done to improve the position of the graft and that as all of the vessels were filling in a normal manner, and the graft wasn¿t moving to withdraw and allow the patient to recover.Upon further examination of the final angiograms the distal stent of the zta-p-40-21 graft appeared to be separated from the graft material in the posterior of the aorta (near the spine) (pr(b)(4)) attempted to pull and push the zta-p-40-217 in a desirable location but attached in the anterior region, near the coeliac and sma arteries.No additional intervention is planned, only a clinical follow-up.The patient was awakened, and he was observed to be moving both feet and not in any discomfort at that time, as this was another concern due to the coverage of such a large segment of the descending thoracic aorta.The patient was being held in hospital under observation as was planned, and otherwise was well, and was able to move his limbs.Review of the device history record gave no indication of the device being produced out of specification.No imaging was provided.It was not possible to evaluate the blue rotation handle and release wires, as no device was returned for investigation.Therefore, the cause of inability to release the wires during deployment can not be established.Per the event description, the wires were still attached after deployment, and this resulted in the graft being pulled down.It was reported as a human error.According to the instruction for use "under fluoroscopy, turn the blue rotation handle in the direction of the arrow until a stop is felt.This indicates that the uncovered stent and proximal end of the graft have opened and that the distal attachment to the introducer has been released." it is noted that zta devices are used for treatment of dissection which is outside of intended use.Additionally, it is noted that two zta-pt and one zta-p used in combination.According to the instructions for use, the proximal component can be either tapered or non-tapered and may be used independently or in combination with a distal component.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, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 16085138
• MDR Text Key: 306501564
• Report Number: 3002808486-2023-00004
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002347097
• UDI-Public: (01)10827002347097(17)251103(10)E4327199
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 06/21/2023

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-40-217
• Device Lot Number: E4327199
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2022
• Initial Date FDA Received: 01/03/2023
• Supplement Dates Manufacturer Received: 02/17/2023; 06/14/2023
• Supplement Dates FDA Received: 02/22/2023; 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2022
• 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 Sex: Male