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

Catalog Number UNKNOWN

Device Problems Device Dislodged or Dislocated (2923); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems No Information (3190); 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 zenith alpha graft.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a secondary intervention is scheduled on a case from a couple years ago.The case is schedule on (b)(6) 2020 and reason for the secondary intervention is for component separation of zenith alpha grafts, which is believed to be caused by the tortuosity of the anatomy.

Manufacturer Narrative

Manufacturers ref# (b)(4) 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

Additional information received on 09dec2020: tevar (b)(6) 2017 zta-p-40-167-w proximally, followed by zta-p-46-125-w hybrid debranching/tevar (b)(6) 2018 zta-36-32-161-w placed distally, then telescoped zta-pt-42-38-225-w, followed by zta-pt-42-38-173 into the zta-p-40-167-w.Secondary intervention due to separation of the zta-36-32-161-w from the zta-pt-42-38-225.Clinical signs prior to the secondary intervention aneurysm growth present due to separation.No endoleak documented between 6 mo.Visits.Aneurysm measures 6.3 cm.

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: a patient underwent initial tevar in 2017 where a zta-p-40-167-w was placed proximally, followed by zta-p-46-125-w.The patient then got a hybrid debranching tevar in 2018 where a zta-36-32-161-w placed distally, then telescoped zta-pt-42-38-225-w, followed by zta-pt-42-38-173 into the previously placed zta-p-40-167-w.In (b)(6) 2020 a separation of the zta-36-32-161-w from the zta-pt-42-38-225 was observed and an additional procedure was performed with two zta-pt devices.According to the physician the patient had tortuous anatomy and tortuosity was present prior to first tevar in 2017.A single ct study were provided and reviewed by an imaging expert.The imaging expert confirms the event in this complaint based on the provided ct.Per the findings of the imaging review ¿the 3rd overlapping zta graft (likely the 42-38 x 225 mm tapered component from the secondary intervention) extends distally by another 68 mm and terminates in another severe >90-degree angulation in the distal thoracic aorta.There is no distal graft wall apposition here and complete loss of overlap with the next zta component resulting in a large type 3a endoleak perfusing the aneurysm sac.The maximum sac diameter is 66 mm in the distal thoracic aorta¿ and ¿the next zta component (36-32 x 161 mm tapered component from the secondary intervention) begins just below the celiac trunk about 89 mm below the distal edge of the previous graft.This component lacks any proximal graft wall apposition in the aneurysmal aorta but there is no endoleak seen around this graft in the distal segment of the taaa sac¿.Based on these findings the imaging reviewers¿ impressions is ¿the current study shows an extent ii taaa.There is severe tortuosity of the thoracic aorta with 2 separate angulations >90 degrees and a significant 65-degree angulation of the infrarenal aorta.Previous imaging is not provided to compare this anatomy to that at the time of the initial repair or the secondary intervention.The current anatomy, however, is outside the ifu for these devices.It cannot be determined if this was progression of disease of the taa after the initial repair (requiring the secondary intervention) or if the initial preop imaging also showed an extensive taaa which was inadequately treated during the primary repair.It is reported the distal 2 components were overlapped during the previous secondary intervention.The loss of component overlap is most likely due to progression of disease and significant elongation of the distal thoracic aorta with severe resulting tortuosity and complete distraction of the distal 2 zta components.Previous imaging would be needed to confirm this by comparing the aortic anatomy and the position and overlap of components at the time of the secondary intervention.According to the instructions for use, shipped with this type of devices "no localized angulation should be larger than 45 degrees".It has not been possible to establish an exact cause of the event but based on the imaging review patient anatomy could have contributed to the separation of the stent grafts.Cook will reopen the investigation if further information is received.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
• MDR Report Key: 10994344
• MDR Text Key: 223456766
• Report Number: 3002808486-2020-01124
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P140016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2021

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
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 12/09/2020; 07/12/2021
• Supplement Dates FDA Received: 12/21/2020; 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 113