MAUDE Adverse Event Report: WILLIAM COOK EUROPE UNKNOWN; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number UNKNOWN

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

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Article: multibranched endovascular repair using a modified endograft with hydrogel-reinforced fenestrations.Azuma et al., 2022.Catalog# is unknown but referred to as a cook zenith alpha stent graft.Similar to device under pma: 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

Description of event according to article azuma et al., 2022: the 40 patients underwent tevar for the indications listed in the article, this was primarily taaa.A physician-modified endograft (pmeg) based on zta was used in all patients.The four-fenestrated pmeg was made by burning fenestrations in the graft material and reinforcing these fenestrations with an azur peripheral hydrocoil.At the procedure, both femoral arteries were surgically exposed, the pmeg was implanted, the fenestrations were cannulated using an antegrade or retrograde approach, and bridging stents were implanted.All smas and renal arteries were revascularized, but the celiac artery was only revascularized in 29 patients because the ca was naturally occluded in 2 patients and had been occluded previously in 9 patients.Patient outcome: 3 patients experienced perioperative type ib endoleak.

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).Article: multibranched endovascular repair using a modified endograft with hydrogel-reinforced fenestrations.Azuma et al., 2022.Summary of investigational findings: during a literature review cook became aware of the article ¿multibranched endovascular repair using a modified endograft with hydrogel-reinforced fenestrations¿.This article is a study over 40 patients receiving a physician-modified endograft (pmeg) with hydrogel-reinforced fenestrations.The pmeg was in most cases made by modifying a zta-d (80% of cases) and in some cases a zta-de (20% of cases) was used.The graft was deployed on the back table and modified using a low-temperature cautery to burn fenestrations.The fenestrations were then reinforced with a coil from another manufacturer before the device was resheathed into the original sheath.It was reported that on postoperative ct angiography performed within 1 week, type ib endoleaks were observed in 3 cases.Per the instructions for use sent with this type of device the zta is intended for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta.The patient in this complaint received a pmeg placed in the abdominal aorta.The effects of the design modifications relative to the device¿s characteristics are unknown and the subsequent potential impact on the performance or effectiveness of the stentgraft can not be established.Requests have been sent to obtain more detailed information about the events in the article, however no more information has been made available.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: UNKNOWN
• 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: 15602825
• MDR Text Key: 301733441
• Report Number: 3002808486-2022-00981
• 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: 01/10/2023

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/10/2023
• 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): Life Threatening