MAUDE Adverse Event Report: WILLIAM A. COOK AUSTRALIA, PTY LTD ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY; MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number ZFEN-P-2-30-124

Device Problems Positioning Failure (1158); Premature Activation (1484); Malposition of Device (2616)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2023

Event Type  malfunction  

Event Description

Diameter reducing ties appear to have deployed during initial unsheathing of device.Device had wall contact and was not able to be repositioned.

Event Description

Diameter reducing ties appear to have deployed during initial unsheathing of device.Device had wall contact and was not able to be repositioned.On 22/2/23 received reply from the representative: updated on 15tgh march 23.Question: has the physician determined possible contributing factors that may have contributed to the reported event? - dr has not confirmed yet.Question: was the device ifu followed? if yes, has the device functioned as expected while following the ifu? if no, please provide details.Yes - device deployed as per ifu.Question: was any difficulty experienced during deployment? if yes, please provide details.- yes - the graft appeared to have wall contact, however diameter reducing ties were not deployed yet.No difficulty with unsheathing.Question: was the patient¿s anatomy tortuous? no.Question: are any ¿procedural notes¿ available? if so, please provide.Dr has not confirmed yet.Question: was the device inspected prior to use in order to ensure no damage has occurred? yes.Question: was there any difficulty positioning graft? - yes - the graft appeared to have wall contact, however diameter reducing ties were not deployed yet.Question: was there any difficulty withdrawing trigger wires? no.Question: was the delivery system rotated together as per the ifu? yes.

Event Description

Diameter reducing ties appear to have deployed during initial unsheathing of device.Device had wall contact and was not able to be repositioned.On 22/2/23 received reply from the representative: updated on 15th march 23.Question: has the physician determined possible contributing factors that may have contributed to the reported event? - dr has not confirmed yet.Question: was the device ifu followed? if yes, has the device functioned as expected while following the ifu? if no, please provide details.Yes - device deployed as per ifu question: was any difficulty experienced during deployment? if yes, please provide details.- yes - the graft appeared to have wall contact, however diameter reducing ties were not deployed yet.No difficulty with unsheathing.Question: was the patient¿s anatomy tortuous? no question: are any ¿procedural notes¿ available? if so, please provide.Dr has not confirmed yet.Question: was the device inspected prior to use in order to ensure no damage has occurred? yes question: was there any difficulty positioning graft? - yes - the graft appeared to have wall contact, however diameter reducing ties were not deployed yet.Question: was there any difficulty withdrawing trigger wires? no question: was the delivery system rotated together as per the ifu? yes.

Manufacturer Narrative

The grafts remain in situ, so the product was not returned for evaluation.Images were provided and reviewed by the medical director.The medical director stated the following: the segment of the aorta just above the renal arteries, forming the neck of the aneurysm, measures about 23mm at its smallest diameter.The diameter mismatch may have caused the problem.The following additional information was received: question: has the physician determined possible contributing factors that may have contributed to the reported event? ¿ dr has not confirmed yet.Question: was the device ifu followed? if yes, has the device functioned as expected while following the ifu? if no, please provide details.Yes - device deployed as per ifu question: was any difficulty experienced during deployment? if yes, please provide details.- yes - the graft appeared to have wall contact, however diameter reducing ties were not deployed yet.No difficulty with unsheathing.Question: was the patient¿s anatomy tortuous? no question: are any ¿procedural notes¿ available? if so, please provide.Dr has not confirmed yet.Question: was the device inspected prior to use in order to ensure no damage has occurred? yes question: was there any difficulty positioning graft? - yes - the graft appeared to have wall contact, however diameter reducing ties were not deployed yet.Question: was there any difficulty withdrawing trigger wires? no question: was the delivery system rotated together as per the ifu? yes a review of device history record for work order (b)(4) was reviewed and appears complete and correct.The device was manufactured to specification and did not reveal any discrepancies that could have contributed to the adverse event.The instruction for use (ifu) supplied with the device states: general information: table 9.5.1 proximal body graft diameter sizing shows that a 23 mm intended aortic vessel diameter should be matched with a 28 mm main body diameter.Based on the information it is likely that the mismatch of graft diameter with the vessel diameter may have contributed to this complaint.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Type of Device: MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane ; AS
• Manufacturer Contact: meena harish ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 16449045
• MDR Text Key: 310340342
• Report Number: 9680654-2023-00016
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002381602
• UDI-Public: (01)10827002381602(17)260117(10)AC1126168
• Combination Product (y/n): N
• PMA/PMN Number: P020018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/10/2023

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: ZFEN-P-2-30-124
• Device Lot Number: AC1126168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 02/27/2023
• Supplement Dates Manufacturer Received: 02/14/2023; 02/14/2023
• Supplement Dates FDA Received: 03/15/2023; 04/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2023
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Male