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

Catalog Number ZTEG-2P-42-135-PF-US

Device Problems Flaked (1246); Insufficient Information (3190)

Patient Problems Death (1802); Embolism (1829); Embolus (1830)

Event Date 04/29/2015

Event Type  Death  

Manufacturer Narrative

Manufacturers reference: (b)(4).Investigation is still in progress.

Event Description

Description of event according to complainant: the physician reported that a couple of months ago, there was an unfortunate tevar (thoracic endovascular aneurysm repair) case on a very high risk patient.The patient died of massive micro-embolization, a complication that he anticipated that could happen, but he decided to do the repair because of the exceedingly large aneurysm.The physician just received the autopsy report; which showed "widespread micro-embolization of hydrophilic polymer to the kidneys, colon, rectum and lower extremities".The physician commented: "i don't think this was the cause of death." "i do think it was from cholesterol embolization".Patient outcome: the patient died of massive micro-embolization.

Manufacturer Narrative

(b)(4).Pt identifier) unknown as information was not provided.Age/date of birth) unknown as information was not provided.Weight) unknown as information was not provided.Implant date) unknown as information was not provided.(b)(4).Summary of investigational findings: autopsy report noted immediate cause of death as widespread microembolization of hydrophilic polymer to the kidney, colon, rectum and legs.Zenith delivery systems are coated with hydrophilic polymer to act as a lubricant during advancement to the intended vessel location.Due to tortuous anatomy and advancement difficulty, it is feasible to suggest that particles of coating dislodged from the surface of the sheath.Additional information provided by the physician and a review conducted by an independent physician indicate there is also a potential that the embolization occurred due to atherosclerotic emboli due to the patient's anatomy.Review of production records for all devices used noted the zteg-2pt--38-152-pf-us of wce lot# e3139358 was built using cinc sheath subassembly lot #f4336455.This cinc lot# noted the coating date of (b)(6) 2013, which is prior to implementation of coating process optimization on (b)(6) 2013.Process optimization resulted in thinner coating, better uv curing and improved coating adhesion; therefore, while not definitive, it is most likely that the hydrophilic polymer emboli found at autopsy originated from this device than others noted.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to complainant: the physician reported that a couple of months ago, there was an unfortunate tevar (thoracic endovascular aneurysm repair) case on a very high risk patient.The patient died of massive micro-embolization, a complication that he anticipated that could happen, but he decided to do the repair because of the exceedingly large aneurysm.The physician just received the autopsy report; which showed "widespread micro-embolization of hydrophilic polymer to the kidneys, colon, rectum and lower extremities".The physician commented: "i don't think this was the cause of death." "i do think it was from cholesterol embolization" patient outcome: the patient died of massive micro-embolization.

• Brand Name: ZENITH TX2 TAA ENDOVASCULAR GRAFT PROXIMAL COMPONENT
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM COOK EUROPE; 4632 bjaeverskov; DA
• Manufacturer Contact: marianne hoey ; sandet 6; bjaeverskov 4632 ; DA 4632 ; 56868686
• MDR Report Key: 5009494
• MDR Text Key: 23215936
• Report Number: 3002808486-2015-00096
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZTEG-2P-42-135-PF-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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): Death