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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Material Puncture/Hole (1504); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Article: https://doi.Org/10.1016/j.Jvscit.2020.05.005.Catalog# is unknown but referred to as cook tx2 distal extension.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: initial repair of the taaa was done by bevar where a 4-branched stent graft was created by the physician via modification of a tx2.The modification included sewing on viabahn covered stents (from another manufacturer) on the tx2 stent graft to create 4 directional branches.After the procedure there was initially a decrease in sac diameter, but at 35 months after the procedure the aneurysm sac had enlarged.Enlargement continued.Patient outcome: the stent grafts remained in the patient as intended.Occult endoleak.4 years after the initial procedure, endovascular repair by bevar was needed.

Event Description

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

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: during a literature review cook became aware of the article ¿total realignment of multibranch stent graft using redo branch-in-branch endovascular repair for occult endoleak with rapid aneurysm sac expansion¿.This article is a case report describing a 65-year-old man with multiple sclerosis who had a thoracoabdominal aneurysm which was treated with a physician modified endograft (pmeg) based on a tx2 stentgraft.The tx2 stentgraft was modified with four directional branches constructed using viabahn stent grafts anastomosed with running 5-0 suture.After the procedure the patient had decrease in sac diameter from 82 mm to 70 mm 4 months after the index procedure with no evidence of endoleak.However, at 35 months, the aneurysm sac enlarged to 89 mm, reaching 103 mm at 45 months.During this interval, multiple 1-mm-slice cta was performed with delayed-phase sequences, all of which failed to demonstrate an endoleak.Two ceus examinations were performed by a dedicated team of vascular radiologists and technologists, both of which confirmed no evidence of endoleak.46 months after the procedure the patient presented emergently with severe new-onset thoracic back pain and cta demonstrated rapid expansion of 5 mm in 1 month and new fresh blood products within the aneurysm sac in the non-contrast-enhanced phase, indicating an occult endoleak despite no evidence of any endoleak in the arterial phase and in two delayed phase sequences.Furthermore, the patient was diagnosed with disseminated intravascular coagulopathy (dic).The authors hypothesized that the progressive thrombocytopenia resulted from dic due to platelet consumption within the excluded aneurysm sac.The authors speculated that the endoleak might originated from the anastomotic line of one or more of the directional branches and needle holes from the diameter-reducing tie, although this could not be demonstrated.An additional procedure with total realignment of the branched endograft was performed using a new pmeg stentgraft based on a zta stentgraft (pr377049).Per the instructions for use sent with this type of device the zenith tx2 taa endovascular graft with pro-form and the z-trak plus introduction system is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta.Furthermore, the device should not be re-sheathed after deployment.Based on the information provided in the article it is likely that the described endoleak stems from the modifications done to the stent graft.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.

• 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: 15560701
• MDR Text Key: 301345067
• Report Number: 3002808486-2022-00971
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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?: No
• 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: 10/05/2022
• Initial Date FDA Received: 10/07/2022
• Supplement Dates Manufacturer Received: 11/17/2022
• Supplement Dates FDA Received: 11/22/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male