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

Catalog Number UNKNOWN

Device Problems Improper or Incorrect Procedure or Method (2017); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Ischemia Stroke (4418); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as cook zdeg.Similar to device under pma/510(k) p180001.(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.

Event Description

Description of event according to initial reporter: a 49-year-old male patient underwent emergency tevar 5 years ago due to extensive ischemia below the abdomen caused by acute type b dissection.The proximal device was placed in zone 2 with an axillary-axillary artery bypass (ax-ax).The device was a txd, 34mm in the proximal and tapered 24m in the distal site and 36mm bare stent was added to the distal device.The left subclavian artery (lsca) origin was not embolized.Postoperatively, ischemia was resolved and remodeling was successful.This time, cerebellar infarction occurred on the patient.The cause was found to be that the origin of the lsca was partially patent by migration of the proximal device, and a thrombus at the root traveled to the left vertebral artery area.Follow-up ct showed gradual migration of the device.After symptoms of the cerebellar infarction got calmed, additional tevar was performed in the proximal site.Patient outcome: the patient had a favorable outcome after the operation.

Manufacturer Narrative

Manufacturers ref# (b)(4).H6) e2402 - appropriate term / code not available for cerebellar infarction.Summary of investigational findings: this complaint adresses cerebral infarction.From a publication review, cook medical became aware of a literature article 27may2022.The article describes a 49-year-old male patient underwent emergency tevar 5 years ago due to extensive ischemia below the abdomen caused by acute type b dissection.The proximal device was placed in zone 2 with an axillary-axillary artery bypass (ax-ax).The device was a txd, 34mm in the proximal and tapered 24m in the distal site and 36mm bare stent was added to the distal device.The left subclavian artery (lsca) origin was not embolized.Postoperatively, ischemia was resolved and remodeling was successful.This time, cerebellar infarction occurred on the patient.The cause was found to be that the origin of the lsca was partially patent by migration of the proximal device, and a thrombus at the root traveled to the left vertebral artery area.Follow-up ct showed gradual migration of the device.After symptoms of the cerebellar infarction got calmed, additional tevar was performed in the proximal site.Discussion/conclusion: ¿although remodeling of the aorta seems to be successful in tevar for acute type b dissection, migration to the distal side may occur during the period after the initial treatment as the proximal side may not be oversized.This is especially important in the case of a 10mm taper dissection.This migration is hard to be recognized, so we should always keep it in mind during follow-up ct.In some cases, it may cause cerebral infarction in the left vertebral artery region.Per the reported information, the cause of cerebral infarction was found to be that the origin of the lsca was partially patent by migration of the proximal device, and a thrombus at the root traveled to the left vertebral artery area¿.The meaning of the ¿root¿ was not elaborated.Per the reported information from the rep, but not confirmed by the physician ¿for dissection cases, physicians tend not to make usual device selection* (*usual device selection: 4 mm up against the native vessel) by considering the fragility of the vessel in the proximal neck but they select a device of the same diameter as the vessel or only one size up (oversize).Therefore, this statement is likely to be saying that the non-oversized device selection could cause migration easily.¿ no imaging was provided for investigation.Per the sizing guide for proximal tapered devices ¿ 10 mm, aortic vessel with proximal diameter measured to 30 mm and distal diameter measured to 21 mm requires the device with graft diameter on 34 mm proximally and 24mm distally.According to the ifu, sizing outside of the recommendations can result in device migration.The information regarding vessel size was not provided.If sizing was according to the information provided by rep.(a device of the same diameter as the vessel or only one size up), the vessel diameter would be 34 or 33 mm.The choice of the device with proximal diameter on 34 mm is outside of recommendations in the sizing guide for proximal tapered devices for these vessel diameters.Based on the provided information, the cause of cerebral infarction is likely related to the stent graft migration which resulted in the left subclavian artery became patent and a thrombus traveled to the left vertebral artery.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.

Event Description

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

• 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: 14785552
• MDR Text Key: 294564509
• Report Number: 3002808486-2022-00855
• 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,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

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?: 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: 05/27/2022
• Initial Date FDA Received: 06/23/2022
• Supplement Dates Manufacturer Received: 11/23/2022
• Supplement Dates FDA Received: 11/24/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male