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-42-216-PF

Device Problems Bent (1059); Failure to Advance (2524)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Summary of investigational findings: based on the available information it has not been possible to determine the reason for the experienced advancement difficulties.It is plausible that the calcification in the vessels contributed to this event.However, root cause remains unknown.No evidence to suggest device not manufactured to current specifications.Cook medical will continue to monitor for similar events.

Event Description

Description of event according to initial reporter: an (b)(6) female patient underwent taa repair with right fa approach.Access route was confirmed to be larger than the main device (approximately 9 mm).Though sporadic calcifications could be observed, these would not possibly obstruct advancement of the delivery system since the calcifications were dotted.The patient was suitable for endovascular repair.The physician was a supervisory doctor and complied with ifu.Zteg-2p-38-152-pf was placed in the distal site first, then delivery system of zteg-2p-42-216-pf was advanced from the right fa to be placed in the proximal site.The delivery system could advance smoothly up to the cia though, the physician felt strong resistance when it entered to the aorta.Since tip of the device looked slightly bent on angiography, the delivery system was removed.The physician judged that it would be risky to continue to use the device, another device (zteg-2p-42-162-pf) was used instead ((b)(4)).Delivery system of zteg-2p-42-162-pf could advance with no problem and the stent graft was placed in the proximal side.Final angiography confirmed slight proximal type i endoleak though, the procedure was finished with no additional treatment since there was no backup device ready in the hospital.The physician took a wait-and-see approach and will plan an additional treatment as necessary ((b)(4)).The patient recovered and in stable condition.Patient outcome: the patient recovered and in stable condition as of (b)(6) 2013.

• 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: 6338539
• MDR Text Key: 67660799
• Report Number: 3002808486-2017-00524
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002527031
• UDI-Public: (01)10827002527031(17)160117(10)E3032821
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ZTEG-2P-42-216-PF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2013
• Initial Date FDA Received: 02/17/2017
• Date Device Manufactured: 01/17/2013
• 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 Age: 87 YR