MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number G53451

Device Problem Flaked (1246)

Patient Problems Cardiac Arrest (1762); Death (1802); Paraplegia (2448); Multiple Organ Failure (3261)

Event Type  Death  

Manufacturer Narrative

(b)(4).Catalog# zteg-2pt-40-208-pf-us.(b)(4).Investigation is still in progress.

Event Description

Description of event according to initial reporter: "on a meeting on monday, physician indicated he had a patient that underwent a procedure and died a few days post op from multi-organ failure.Autopsy determined some of the hydrophillic coating in the organs, assumed from the delivery system." patient outcome: pt is deceased.

Manufacturer Narrative

(b)(4).Name and address for importer site: (b)(4).Summary of investigational findings: a preoperative cta study is provided along with the complaint report and autopsy report.The microscopic identification of hydrophilic polymer emboli within multiple tissues suggests that this may be a contributor to the various ischemic and infarction events that occurred in this patient.The origin of this material appears to be from polymer-coated sheaths covering various types of catheters, guidewires, coils and other intravascular devices.According to the provided imaging, there is no device implanted on the current study so this finding regarding use of the device is based on the reported implantation subsequent to this study.The specifications and profile of the device(s) implanted are not provided.However, given the proximal aortic neck measurements of 33 mm to 36 mm, a proximal thoracic component would need to be a 40 mm device.The autopsy report lists zteg 40 x 208 mm, zteg 36 x 157 mm, and zteg 32 x 160 mm devices, though it¿s not clear if these are the confirmed devices used.The introducer sheath for the tx2 32 mm is 20 french with an outer diameter of 7.7 mm while 36 mm and 40 mm device is 22 french with an outer diameter of 8.5 mm.All of these introducer sheaths exceed the bilateral access artery diameters.Combined with a fixed diameter stent in the right iliac artery and significant calcification in bilateral iliac arteries, these access vessels are outside of ifu for the presumed devices used, and could lead to significant difficulty in introducing and passing the above devices.Furthermore, there is significant atherosclerotic disease and calcification in the distal abdominal aorta.The abdominal aorta has a lumen of 11.1 mm with severe circumferential calcification.It is not possible to establish a direct link between the identified emboli and the used devices.However; the calcification and the size of the access vessel can possibly contribute to the reported event.The autopsy report states that cause of death was systemic shock, resulting in multisystem organ failure, most significantly being severe liver ischemia.Although some microemboli were found in the liver ¿associated with surrounding necrosis, not all areas of necrosis were associated with emboli.¿ in addition, the physician states polymer material ¿appears to be present on numerous types of devices, many of which were potentially used during the operative/post-operative course of this patient.¿ also, the physician states, ¿the ability to establish a direct link between these emboli and the various infarction events is made very difficult by the complex post-operative course.¿ little is known regarding the post-operative course and all devices that were used on this patient post-operatively.Attempts have been made to obtain this information with no success.Per the autopsy report, the source of the polymer coating was not determined.There is no evidence in the medical record that indicates the only source or primary source of the polymer coating was from the flexor sheath.There is no evidence in the autopsy report that indicates a causal relationship between the zenith flexor sheath and the patient¿s systemic shock.There is no evidence in the autopsy report that indicates a causal relationship between the flexor sheath and the patient¿s death.The autopsy report does not contain a history and physical which would shed light on the patient¿s diagnoses and medications that could have also contributed to the patient¿s death.The device was not returned for evaluation.Without visual, dimensional, and/or functional testing of the product, we are unable to determine if this is a manufacturing issue.Based on current information, there is no conclusive cause for the patient¿s systemic shock and subsequent death.At this time, clinical assessment cannot eliminate any possible causes for the patient¿s systemic shock and subsequent death such as user technique, product handling, human anatomy, device failure, or manufacturing related causes.Cook medical will continue to monitor for similar events.

Manufacturer Narrative

Manufacturer ref# (b)(4).Article: hydrophilic polymer embolization after thoracic endovascular aortic repair.Yang et al., 2019.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

Additional information received from article 30oct2019: the procedure was a hybrid procedure of abdominal visceral debranching and tevar for repair of thoracoabdominal aneurysm.A 74-year-old woman had her extent ii thoracoabdominal aortic aneurysm treated by a hybrid procedure of abdominal visceral debranching and tevar.Following an infrarenal aortobifemoral bypass four-vessel debranching was completed.On the back table, a 6-mm hybrid graft was sewn onto an 8-mm hybrid graft.The 8-mm proximal graft was then sewn onto the right external iliac artery.The 6- and 8-mm grafts were then deployed into the left renal artery and the superior mesenteric artery (sma), respectively.Similarly, another y-configuration hybrid graft was made with 7- and 8-mm hybrid grafts deployed into the right renal and celiac arteries, respectively, with the inflow from the left external iliac artery.Last, an 11-mm pete graft was sewn onto the aortobifemoral bypass as an endovascular conduit.A 32 x 160-mm tapered cook alpha thoracic graft was first deployed.A tapered 40 x 208- mm tapered graft was then inserted and landed distal to the subclavian artery.Last, a third tapered 36 x 157-mm graft was inserted as a bridge.A compliant balloon was used in the graft overlap regions and the distal seal zone.No sign of endoleak was noted, and successful perfusion to the four visceral vessels was observed.At the end of the procedure, the right leg demonstrated some signs of worsening ischemia, and therefore simple balloon angioplasty was done.Postoperatively, she developed an acute kidney injury as well as aspiration pneumonia.She was extubated on postoperative day (pod) 7 but suffered a bradycardiac arrest on pod 8, requiring reintubation.After arrest, she was found to have a subacute stroke, probably secondary to an embolic shower to the left frontal and occipital cortex, leaving her with partial right hemiparesis.On pod 14, she went into shock and fulminant hepatic failure.Ct imaging demonstrated a grossly ischemic liver and an ischemic left kidney.She became densely paraplegic on pod 15.The patient was transitioned to comfort care and died on pod 17.Autopsy determined the cause of death to be systemic shock and multiorgan failure.Microscopic hydrophilic polymer emboli within multiple organs likely contributed to tissue infarction.Scattered nonorganic microemboli in the liver, kidneys, brain, lungs, spleen, bowel, and lower extremity soft tissue were found.However, all visceral bypass grafts were patent.The pathology report described the appearance of the hydrophilic polymer embolic material as similar to that in previous reports.It is unclear whether the polymer emboli contributed to the intraoperative finding of worsening right leg ischemia.Patient outcome: additional information received from article 30oct2019: the patient had worsening of an ischemic leg at the end of the procedure.Later, she suffered from kidney injury, aspiration pneumonia, bradycardiac arrest, stroke, hemiparesis, shock, hepatic failure.The patient died on postoperative day 17.Autopsy revealed hydrophilic polymer microemboli within multiple organs.The zenith alpha thoracic and zenith tx2 taa has a hydrophilic coating on the introduction system, and thus could be contributing to the adverse effects.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: this complaint was reopened based on the article ¿hydrophilic polymer embolization after thoracic endovascular aortic repair¿ published in 2019.The article was clinically evaluated and it was found that case #1 was similar to the case described in this complaint despite some inconsistencies between the reported information for this complaint e.G.The rpn provided with the autopsy report and the information in the article.In the clinical assessment it was noted that the article describes the implant procedure as a hybrid procedure with open and endovascular procedures combined, this is outside of the intended use for these devices.The information in the article does not change the conclusion or risk assessment of this complaint.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.

Event Description

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

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT
• 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: 6823343
• MDR Text Key: 83767114
• Report Number: 3002808486-2017-01664
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002534510
• UDI-Public: (01)10827002534510(17)170726(10)E3240378
• Combination Product (y/n): N
• PMA/PMN Number: P070016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,other,user
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: G53451
• Device Catalogue Number: ZTEG-2PT-40-208-PF-US
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/18/2017
• Date Manufacturer Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 74 YR