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

Model Number G35391

Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Open or Close (2921); Activation Failure (3270)

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

Event Date 05/28/2022

Event Type  Injury  

Event Description

Description of event according to initial reporter: patient with previous repair had a graft (unknown manufacturer) 12 months ago.An endoleak was noted and a g35391-zta-d-34-142-w was used in attempt to repair the endoleak.Four, possibly five stents appeared to not open.All but one was able to be resheathed.The last stent was able to be removed by slowly removing the whole delivery system.The procedure was completed using a g35351-zta-p-34-161-w, e4239129.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Manufacturer ref# (b)(4).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.

Event Description

Add info received on (b)(6)2022: when the physician brought back the sheath to deploy the stent graft the stents did not appear to open.The physician brought back the sheath about 5 stent lengths before deciding to re-advance sheath and remove the device from the patient.The zta-d-34-142-w was replaced with a zta-p-34-161-w.Add info received on (b)(6)2022: information concerning the unknown graft (used in the first procedure, 12 months ago): 30sep2017: right to left carotid to carotid bypass 7mm (another manufacturer), left carotid to subclavian artery bypass 7mm (another manufacturer), tevar with 36-32mm and 32mm cook alpha stent grafts with innominate snorkel with 13mm stent graft (another manufacturer), stent (another manufacturer) placement in the distal aortic arch.03oct2017: open repair of aaa with aortobiiliac graft graft 22mm x 11mm with visceral artery debranching with two 14mm x 7mm bifurcated grafts off aortoiliac reconstruction.13nov2017: redo stenting of right innominate stent with 10mm x 38mm (another manufacturer) and 10mm x 40mm(another manufacturer) and tevar from prior stent graft to infra-renal aortic graft with 32-28mm, and 2 28mm cook alpha grafts.04dec2017:embolization of left subclavian artery.28may2022: 1.Left femoral artery open exposure for introduction of endovascular stent graft.2.Endovascular stent graft repair of distal type 1b endoleak with an abdominal distal endovascular extension cuff 34 mm-161 mm alpha thoracic stent graft from cook medical.3.Intravascular ultrasound.

Manufacturer Narrative

Manufacturer ref# pr365036 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

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

Manufacturer Narrative

Manufacturers ref# pr(b)(4).Summary of investigational findings: a patient presented with an endoleak from a previous repair 12 months ago (included several devices).The complaint device zta-d-34-142-w was used in an attempt to repair the endoleak.During retraction of the sheath, four to five stents appeared not to open.All but one was re-sheathed.The last stent was able to be removed by slowly removing the whole delivery system.A zta-p-34-161-w was used to complete the procedure.An angiogram procedure and postop ct study were provided and an imaging review was performed by an imaging expert.According to the imaging review, one angiogram procedure is dated (b)(6) 2022.This is 56 months following the primary tevar procedure on (b)(6) 2017 and 55 months post-secondary intervention for distal tevar extension on (b)(6) 2017.An extensive thoracoabdominal aortic aneurysm was previously repaired by arch debranching and multiple zta grafts extending from the ascending aorta (with innominate snorkel) to the suprarenal aorta and concomitant abdominal aortic debranching and surgical aortobiliac graft placement.At 55 months, there is a type 1b endoleak at the distal zta component (p-28-155) where it lands in a severe angulation (at least 75 degrees) in the suprarenal aorta.This is confirmed on the angiogram study.A new zta device (d-34-142) (complaint device) is delivered from the left iliac graft up to the mid segment of the distal zta component.The first 3 stents are unsheathed along the overlap but the graft incompletely expands.The cause of the incomplete deployment cannot be determined from the imaging provided.The severe aortic tortuosity may have contributed to the deployment issues.The introductions system was returned and evaluated.Around 17mm of the proximal part of the stent graft was visible from the sheath tip.The stent graft was still attached to the uat by the nitinol wires.Additionally, deformations were observed on the tip of the sheath.During the evaluation, the stent graft was deployed (according to the ifu) and the stent graft expanded completely in the distal end but incomplete in the proximal end (the 2 proximal stents).At a later inspection, there was a complete expansion of the stent graft.No non-conformances were observed by inspection of the stent graft.Factors that may affect immediately expansion is the compressed dry state that the stent graft presented in after deployment.Furthermore, the stent graft had been exposed to a partial deployment and re-sheathing before returning it to cook.The damages observed on the sheath tip was likely caused by the re-sheathing of the stent graft.The device evaluation could not establish a cause for the reported incomplete expansion of the stent graft.Review of the device history record found that all discovered non-conformances were properly dispositioned before release and no indication that the device was produced outside of specification.Based on the provided information it has not been possible to determine the cause for the incomplete expansion of the first three stents when attempting to deploy the stent graft inside the patient.According to the imaging review, the target segment for the complaint device had at least 75-degree angulation.Per the ifu for this device "no localized angulation should be larger than 45 degrees.".It cannot be ruled out that the angulation did contribute to the device's incomplete expansion.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 ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL 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: 14673529
• MDR Text Key: 294170427
• Report Number: 3002808486-2022-00815
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002353913
• UDI-Public: (01)10827002353913(17)241019(10)E4171075
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2023

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 Model Number: G35391
• Device Catalogue Number: ZTA-D-34-142-W
• Device Lot Number: E4171075
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/28/2022
• Initial Date FDA Received: 06/13/2022
• Supplement Dates Manufacturer Received: 06/20/2022; 12/28/2022
• Supplement Dates FDA Received: 07/04/2022; 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2021
• 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): Life Threatening
• Patient Age: 43 YR
• Patient Sex: Male