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

Model Number G35339

Device Problems Loss of or Failure to Bond (1068); Patient Device Interaction Problem (4001)

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 (b)(4) 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.((b)(4)- fda mfg report# 3002808486-2022-00815) the procedure was completed using a g35351-zta-p-34-161-w, e4239129.Information concerning the unknown graft (used in the first procedure, 12 months ago): (b)(6) 2017: right to left carotid to carotid bypass 7mm (device from another manufacturer), left carotid to subclavian artery bypass 7mm (device from another manufacturer), tevar with 36-32mm and 32mm cook alpha stent grafts with innominate snorkel with 13mm stent graft (device from another manufacturer), stent (device from another manufacturer) placement in the distal aortic arch.(b)(6) 2017: open repair of aaa with aortobiiliac graft 22mm x 11mm with visceral artery debranching with two 14mm x 7mm bifurcated grafts off aortoiliac reconstruction.(b)(6) 2017: redo stenting of right innominate stent with 10mm x 38mm (device from another manufacturer) and 10mm x 40mm (device from another manufacturer) and tevar from prior stent graft to infra-renal aortic graft with 32-28mm, and 2 28mm cook alpha grafts.(b)(6) 2017:embolization of left subclavian artery.(b)(6) 2022: 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.3.Intravascular ultrasound.Patient outcome: unknown.

Manufacturer Narrative

Manufacturer ref# (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.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: it is reported that on (b)(6) 2022, a male patient underwent endovascular stent graft repair of a distal type 1b endoleak related to a cook zenith alpha thoracic stent graft, previously placed on (b)(6) 2017.The repair was performed with an abdominal distal endovascular extension cuff 34 mm-161 mm alpha thoracic stent graft (zta-p-34-161-w) from cook medical.The issue was reportedly resolved after the additional procedure.This complaint is related to (b)(4).(manufacturer ref#3002808486-2022-00815) as the relative locations of the two listed 28mm proximal components implanted on (b)(6) 2017 were not specified in the reported information, a review of the device history record for both were performed.The reviews did not provide evidence that the devices were manufactured outside of specifications.The device master record was reviewed and it was noted that stent graft dimensions are inspected to be in accordance with specifications during manufacturing.An angiogram procedure (dated (b)(6) 2022) and postop ct study (dated (b)(6) 2022) were provided and reviewed by an expert imaging reviewer.As per review findings: ¿angiography shows the distal zta components from the distal ta to the suprarenal abdominal aorta with moderate tortuosity of the grafts.¿.¿there appears to be a small amount of contrast extending around the distal zta component consistent with a type 1b endoleak.¿ from the 1-day postop ct: "there is significant tortuosity throughout the thoracoabdominal segment, including a 65-degree angulation at the distal ta and a 75-degree angulation where the surgical aortobiiliac graft begins.The distal zta extension component lands beyond this angulation and into the proximal surgical graft" the imaging review also noted that the type 1b appears resolved.As per impression of the imaging reviewer: ¿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.¿.¿this severe tortuosity/angulation is outside the ifu for this device and is likely the cause of the failed distal seal and type 1b endoleak.However, since previous imaging is not provided, it cannot be determined if this tortuosity is due to disease progression over the postop period or if this was similar anatomy at the time of initial repair, in which case the repair was done outside of ifu.¿ it is noted that, based on imaging reviewers assessment, the type 1b endoleak was assessed related to the zta-p-28-155-w lot e3547027, why this was selected as the complaint device.As per anatomical requirements section in the instructions for use, no localized angulation should be larger than 45 degrees.Section 4.2 patient selection, treatment and follow-up describes: key anatomic elements that may affect successful exclusion of the thoracic lesion include severe angulation (radius of curvature < 20 mm and localized angulation > 45 degrees).However, as details of patient anatomy, dimensions, tortuosity, disease progression or position of the complaint device prior to the repair date in may 2022 are unknown, it has not been possible to establish a conclusive cause.It was noted that the distal end of the device was landed in the suprarenal (abdominal) aorta.As per ifu, the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta.Endoleak is listed as a potential adverse event in the ifu.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 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: 15603169
• MDR Text Key: 301732144
• Report Number: 3002808486-2022-00984
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002353395
• UDI-Public: (01)10827002353395(17)200202(10)E3547027
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140016
• 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
• Report Date: 01/30/2023

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: 02/02/2020
• Device Model Number: G35339
• Device Catalogue Number: ZTA-P-28-155-W
• Device Lot Number: E3547027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 01/27/2023
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2017
• 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: 43 YR
• Patient Sex: Male