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

Catalog Number UNKNOWN

Device Problems Appropriate Term/Code Not Available (3191); Patient Device Interaction Problem (4001)

Patient Problems Infarction, Cerebral (1771); Death (1802); Seizures (2063)

Event Type  Death  

Manufacturer Narrative

(b)(4).Catalog# is referred to as a zta-pt-32-155.(b)(4).Similar to device under pma/510(k) p140016.Investigation is still in progress.

Event Description

Description of event according to article: the patient was treated for a thoracoabdominal aneurysm.The patient underwent a two-stage procedure.She first had a left carotid-subclavian transposition, which she tolerated well.Three months later, she had her aneurysm treated.A right ilio celiac bypass was done.A 10-mm pete graft was sewn end to side to the right common iliac artery as a conduit.Cook zenith alpha (zta-p-32-155) was deployed in zone 2, covering the origin of the left subclavian artery.Two custom stent grafts were then deployed with perfusion branches in the thoracic aorta and sma branch graft in the abdominal aorta.An iliac branch extension was inserted into the right common iliac artery (zsle 13-56).The patient immediately developed seizure postoperatively and deteriorated on pod 2 when her neurologic responses did not recover.Acute infarction, as well as microbleeds but no occlusion of middle cerebral artery.Autopsy examination confirmed hydrophilic polymer micro-emboli scattered through out the brain.Patient outcome: the stent graft remained in the patient as intended.The patient had seizures immediately after surgery, acute infarction and microbleeds in brain and kidney infarction,and subsequently died.Autopsy revealed hydrophilic polymer microemboli in brain, kidney, aortic adventitia and liver.The zenith alpha thoracic has a hydrophilic coating on the introduction system, and thus could be contributing to the adverse effects.Patient deceased.

Manufacturer Narrative

Manufacturers ref (b)(4).Ec method code: communication/interviews: summary of investigational findings: from a publication review, cook medical became aware of a literature article, ¿hydrophilic polymer embolization after thoracic endovascular aortic repair¿.The article is a case-report, and this complaint is opened based on case #2 in the article.Case #1 is addressed in (b)(4).Case #2 describes a female patient with a history of a type b dissection with intramural thrombus compromising bilateral renal artery flow and loss of the function of the left kidney.After the treatment of the type b dissection an extent 2 thoracoabdominal aneurysm noted at a 2 months follow-up ct.During a 6-year course the aneurysm increased in diameter from 4.2 cm to 6 cm, why it was decided to treat the patient using a two staged hybrid repair.During the second procedure a zta-pt-32-155, two costume made stentgrafts from an unknown provider, a zsle-13-56 and several other stentgrafts were implanted.The patient developed seizure immediately after her surgery.A ct head scan performed on postoperative day 2 revealed restricted diffusion of the left frontal cortex.On postoperative day 5 the patient was transferred to comfort care and eventually she died.Per the article, the autopsy examination confirmed hydrophilic polymer microemboli scattered throughout the brain.Emboli were also found in the right kidney, the aortic adventitia and in the liver.The information given in this complaint, the related complaint (pr#185687) and the article was reviewed, and a clinical assessment was performed.The reviewer comments that despite the evidence of hydrophilic polymer emboli in these cases it cannot be concluded whether the emboli caused or contributed to the deaths.The ifu for zenith alpha devices stated that the zenith alpha thoracic endovascular graft is indicated for the endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having vascular morphology suitable for endovascular repair.In this case the device was used in a hybrid procedure with open and endovascular procedures combined, which is an use that has not been evaluated.Based on the provided information no exact cause can be established.It is unclear how many of the devices used had a hydrophilic coating and it is therefore not possible to determine if the reported hydrophilic polymer emboli stems from the zenith alpha device.Internal actions has previously been initiated by cook inc.Due to complaints reported for "coating comes off/sloughs off/flakes off" between 2010 and 2015 and this action has been effective since 13feb2017.It is not known if the reported device was produced before or after this date.No evidence to suggest that the product was not manufactured according to specifications.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
• MDR Report Key: 9259363
• MDR Text Key: 164389692
• Report Number: 3002808486-2019-01779
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other
• Type of Report: Initial,Followup
• Report Date: 08/07/2020

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: 10/15/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR