MAUDE Adverse Event Report: WILLIAM COOK EUROPE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZTA-PT-38-34-217-W1

Device Problems Material Frayed (1262); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): p140016.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a (b)(6) year old male patient who had aaa repair with other manufacturer's y-graft in 2004 underwent taa repair.The patient anatomy was determined as suitable for endovascular repair.The aneurysm was located at the aorta arch.After 1 debranch was created, the user inserted zta-pt-38-34-217-w1 from the right common femoral artery over a lunderquist wire guide to place the stent graft in the decending aorta starting from zone 2.However the delivery system would not advance any further with very strong resistance when it reached where the external iliac artery was tortuous and anastomosis site of the y-graft implanted in 2004.He removed the delivery system and found the sheath has become slightly kinked and the tip became slightly frayed.The user decided to give up on tevar.Open surgery for vessel replacement will be planned later.Patient outcome: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The patient did require additional procedures due to this occurrence, stated in description of event.

Event Description

Additional information received 23apr2021: the leg of the y-graft previously placed was tortuous.

Manufacturer Narrative

Manufacturer ref# (b)(4).Summary of investigational findings: a 76-year-old male patient who had abdominal aortic aneurysm repair with other manufacturer's y-graft in 2004 underwent thoracic aortic aneurysm repair.The patient anatomy was determined as suitable for endovascular repair.The aneurysm was located at the aorta arch.After 1 debranch was created, the physician inserted zta-pt-38-34-217-w1 from the right common femoral artery over a lunderquist wire guide to place the stent graft in the descending aorta starting from zone 2.Very strong resistance was felt when the device reached where the external iliac artery was tortuous and anastomosis site of the y-graft implanted in 2004 and the delivery system would not advance any further.The physician removed the delivery system and found the sheath has become slightly kinked and the tip became slightly frayed.The physician decided to give up on tevar.Open surgery for vessel replacement will be planned later.No adverse effects on the patient was reported due to the advancement difficulties.Review of device history record gave no indication of the device being produced outside of specifications.Ct images and the planning and sizing sheet were provided and reviewed by an imaging expert.Per the findings of the imaging review ¿there is severe tortuosity of the aorto-iliac segment where an aortobi-iliac graft was previously placed for abdominal aortic aneurysm repair.The legs of this graft show significant redundancy resulting in severe tortuosity at the proximal legs as well as distally at the distal cia anastomoses.There is also moderate calcification and tortuosity of the native proximal right external illiac artery (eia)¿.Based on these findings the imaging reviewers¿ impressions is ¿the difficulty with device delivery is most likely due to the access anatomy and severe tortuosity of the aorto-iliac segment".Based on the imaging review the advancement difficulties was most likely due to patient anatomy.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: ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENTS
• 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: 11699393
• MDR Text Key: 247328838
• Report Number: 3002808486-2021-01132
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002448671
• UDI-Public: (01)10827002448671(17)211220(10)E3809206
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/10/2021

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 Expiration Date: 12/20/2021
• Device Catalogue Number: ZTA-PT-38-34-217-W1
• Device Lot Number: E3809206
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2021
• Initial Date FDA Received: 04/21/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR