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

Catalog Number ZTA-DE-26-104-W1

Device Problems Loss of or Failure to Bond (1068); Off-Label Use (1494); Obstruction of Flow (2423)

Patient Problems Fatigue (1849); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Type  Injury  

Event Description

Description of event according to article: the patient was treated endovascularly for the coarctation, as he refused open repair.First, the stenotic lesion was gently dilated with a coda balloon, then a zta distal extension was implanted.The pressure gradient decreased to 17 mm hg, and the ankle brachial index (abi) improved to 0.9.However, two months later the abi had decreased to 0.7 at 1-year follow-up ct showed that the graft was infolded and a thrombus had formed within the graft.The patient had no symptoms and thus refused intervention.At two years post-operation, the abi had decreased to 0.6 and he had developed refractory hypertension at the upper extremity.The patient now experienced fatigue at exercise, he and agreed to reintervention.The reintervention was performed by open surgery where the zta was partially removed and a j graft shield neo vascular graft was implanted instead.It was noted that the lumen of the zta was severely collapsed and almost completely filled by a thrombus.The postoperative course was uneventful.One year later, the abi had recovered to 0.99/1.06, there were no signs of recurrent stenosis.

Manufacturer Narrative

Manufacturers ref# (b)(4).Blank fields on this form indicate the information is unknown or unavailable.Similar to device marketed under 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

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

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: from a publication review, cook medical became aware of a literature article ¿late open conversion after endovascular treatment for the coarctation of aorta in adult due to restenosis with thrombus¿ in journal of vascular surgery cases, innovations and techniques from september 2022 (japan).The article describes a 22-year-old male patient diagnosed with a thoracic aortic coarctation resulting in hypertension in the upper extremity with a significant pressure gradient from the lower limb (99/56mmhg).The ankle brachial index (abi) was 0.6.The stenotic lesion was severely kinked, and the orifice was pinhole - shaped.The patient was treated endovascularly as he refused open repair.First, the stenotic lesion was gently dilated with a coda balloon, then a zta-de-26-104-w1 (complaint device) was implanted.The pressure gradient decreased to 17 mm hg, and the abi improved to 0.9.However, two months later the abi had decreased to 0.7 and 1-year follow-up ct revealed infolding of the stent graft and thrombus formation inside the graft.The patient had no symptoms and thus refused intervention.At two years post-operation, the abi had decreased further to 0.6 and refractory hypertension at the upper extremity had developed.The patient complained of fatigue on exertion and agreed to undergo reoperation.Open graft interposition was performed under the partial cardiopulmonary bypass through the left fourth intercostal space thoracotomy.When the stenotic lesion was incised, the lumen was severely collapsed and was almost completely filed with organized thrombus.The stent graft was transected and removed, leaving the distal two stents in the native arterial wall because the stents were highly adherent to the arterial wall and no thrombus was inside.The stenosed lesion was replaced with a j graft shield neo 18-mm straight vascular graft.The postoperative course was uneventful.One year later, the abi had recovered to 0.99/1.06 and there were no signs of recurrent stenosis.According to the instructions for use, the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta.Based on the provided information a likely cause of the reported restenosis accompanied by thrombus formation is that the zta stent graft was used for treatment of coarctation, 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.

• Brand Name: ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS
• 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: 15354892
• MDR Text Key: 299289084
• Report Number: 3002808486-2022-00938
• Device Sequence Number: 1
• Product Code: MIH
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/03/2023

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-DE-26-104-W1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/05/2022
• Supplement Dates Manufacturer Received: 01/02/2023
• Supplement Dates FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 22 YR
• Patient Sex: Male