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-2-28-109-R
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A patient of undisclosed gender and age underwent a zfen procedure on (b)(6) 2024 in which the zenith fenestrated aaa endovascular graft proximal body, g32537, was implanted."the proximal body zfen graft was twisted within the sheath.The rra (right renal artery) was a 10mm scallop that was supposed to be at 9:30 and under fluoro/inside the sheath the scallop was at about 1:00.The lra was in what looked to be the correct location (29mm from pe) as well as the anterior posterior marks.Once we started to unsheathe the rra fen started to move towards the patients right some, we had to do some wiggling of the graft to get it closer to the correct position.Once the graft was fully deployed the fen was closer to 10:15 to 10:30 as opposed to 9:30 making cannulation of the renal very difficult.I do not have pictures." additional information received: the physician think the device being incorrectly loaded in the sheath caused the issue the device was inspected prior to use in order to ensure no damage has occurred; no damage had occurred to packaging to device the device was positioned on the patient¿s abdomen prior to insertion to confirm that the graft was in the correct orientation, that was when the discrepancy was discovered.The anterior/posterior markers formed a cross and the tick marker appeared to be in the correct orientation.The anterior markers aligned with the tick mark when the gold markers were checked under fluoroscopy prior to insertion into the patient.The thumb screws (rmts) were aligned at 12 o¿clock, and were aligned with the anterior gold markers.The trigger wire was released per the ifu.The gold markers on the graft were not aligned as per the ifu; the rra was a scallop, was supposed to be at 9:30 and within the sheath it was at about 1:00, once deployed it was at about 10:30.All other markers appeared correct the gold markers did not rotate as per the ifu pre-procedure, the anterior markers were loaded near the inner cannula of the sheath so they did not rotate as expected it was not possible to align all the branches, fenestrations and scallops with the native vessels - not the rra deployment and branch, fenestrations and scallops alignment were done per the ifu the physician was able to land in the correct location but the rra was still misaligned.She had to wiggle the graft in the patient and do some corrective rotation to try to get it to line up the patient anatomy was not tortuous there was difficulty positioning graft there was difficulty accessing fenestrations/scallops/branches - the rra fen, we were unable to canulate before releasing the device from the delivery system no difficulty withdrawing trigger wires no difficulty deploying top cap the delivery system was rotated together as per the ifu no difficulties with the top cap removal or docking of the top cap for withdrawal no resistance on withdrawal of the device no point were the delivery system became twisted? (tortuous anatomy).The device was inspected prior to use in order to ensure no damage has occurred the device was able to be advanced to the target site the anterior markers realign into the correct orientation without adjustment by the physician after the top cap was deployed - but rra scallop did not the fenestrations were not correctly lined up in the sheath before and after deployment of the proximal body.We had to rotate the graft some after it was fully unsheathed to help correct for the right renal misalignment.We also were unable to cannulate the rra scallop while the graft was constrained.We ended up having to fully deploy the graft and try to get in after it was fully deployed but this was very difficult.The anterior markers realigned into the correct orientation without adjustment by the physician after the top cap was deployed, but rra scallop did not.(the rra scallop fenestration was originally at about 1:00 instead of 9:30.All other fenestrations and anterior posterior markers looked correct.As we started to unsheathe the device it started to somewhat self correct and the right renal fenestration started falling towards the patients right.But even once fully unsheathed and with some wiggling the fenestration was still at about 10:30 instead of 9:30.).
Event or Problem Description
A patient of undisclosed gender and age underwent a zfen procedure on (b)(6) 2024 in which the zenith fenestrated aaa endovascular graft proximal body, g32537, was implanted."the proximal body zfen graft was twisted within the sheath.The rra (right renal artery) was a 10mm scallop that was supposed to be at 9:30 and under fluoro/inside the sheath the scallop was at about 1:00.The lra was in what looked to be the correct location (29mm from pe) as well as the anterior posterior marks.Once we started to unsheathe the rra fen started to move towards the patients right some, we had to do some wiggling of the graft to get it closer to the correct position.Once the graft was fully deployed the fen was closer to 10:15 to 10:30 as opposed to 9:30 making cannulation of the renal very difficult.I do not have pictures." additional information received: the physician think the device being incorrectly loaded in the sheath caused the issue the device was inspected prior to use in order to ensure no damage has occurred; no damage had occurred to packaging to device the device was positioned on the patient¿s abdomen prior to insertion to confirm that the graft was in the correct orientation, that was when the discrepancy was discovered.The anterior/posterior markers formed a cross and the tick marker appeared to be in the correct orientation.The anterior markers aligned with the tick mark when the gold markers were checked under fluoroscopy prior to insertion into the patient.The thumb screws (rmts) were aligned at 12 o¿clock, and were aligned with the anterior gold markers.The trigger wire was released per the ifu.The gold markers on the graft were not aligned as per the ifu; the rra was a scallop, was supposed to be at 9:30 and within the sheath it was at about 1:00, once deployed it was at about 10:30.All other markers appeared correct the gold markers did not rotate as per the ifu pre-procedure, the anterior markers were loaded near the inner cannula of the sheath so they did not rotate as expected it was not possible to align all the branches, fenestrations and scallops with the native vessels - not the rra deployment and branch, fenestrations and scallops alignment were done per the ifu the physician was able to land in the correct location but the rra was still misaligned.She had to wiggle the graft in the patient and do some corrective rotation to try to get it to line up the patient anatomy was not tortuous there was difficulty positioning graft there was difficulty accessing fenestrations/scallops/branches - the rra fen, we were unable to canulate before releasing the device from the delivery system no difficulty withdrawing trigger wires no difficulty deploying top cap the delivery system was rotated together as per the ifu no difficulties with the top cap removal or docking of the top cap for withdrawal no resistance on withdrawal of the device no point were the delivery system became twisted? (tortuous anatomy).The device was inspected prior to use in order to ensure no damage has occurred the device was able to be advanced to the target site the anterior markers realign into the correct orientation without adjustment by the physician after the top cap was deployed - but rra scallop did not the fenestrations were not correctly lined up in the sheath before and after deployment of the proximal body.We had to rotate the graft some after it was fully unsheathed to help correct for the right renal misalignment.We also were unable to cannulate the rra scallop while the graft was constrained.We ended up having to fully deploy the graft and try to get in after it was fully deployed but this was very difficult.The anterior markers realigned into the correct orientation without adjustment by the physician after the top cap was deployed, but rra scallop did not.(the rra scallop fenestration was originally at about 1:00 instead of 9:30.All other fenestrations and anterior posterior markers looked correct.As we started to unsheathe the device it started to somewhat self correct and the right renal fenestration started falling towards the patients right.But even once fully unsheathed and with some wiggling the fenestration was still at about 10:30 instead of 9:30.).
Additional Manufacturer Narrative
No part of the device was returned for evaluation.No images were received to assist the investigation.The work order (b)(4) was reviewed for 1 x zfen-p-2-28-109-r and appears complete and correct.There were no non-conformances documented at the time of manufacturing.The associated inspection record confirms that the device appeared to be manufactured to specification, prior to shipment.Review of specifications found that there are a number of processes and checks in place to ensure that the graft is loaded in the correct orientation within the delivery system.Review of the instructions for use (ifu) supplied with the device for general information found it contained appropriate warnings, precautions, and instructions to the user, including: 4.3 implant procedure fluoroscopy should be used during introduction and deployment to confirm proper operation of the delivery system components, proper placement of the graft, and desired procedural outcome to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).5.Adverse events potential adverse events that may occur and/or require intervention include, but are not limited to: death surgical conversion to open repair 10.2 'inspection prior to use' "inspect the device and packaging to verify that no damage has occurred as a result of shipping.Do not use this device if damage has occurred or if the sterilization barrier has been damaged or broken.If damage has occurred, do not use the product and return to your cook representative or your nearest cook office.Prior to use, verify correct devices (quantity and size) have been supplied for the patient by matching the device to the order prescribed by the physician for that particular patient".11.4.5 'proximal body placement' "4.Before insertion, position proximal body delivery system on patient¿s abdomen under fluoroscopy to assist with orientation and positioning.Rotate to a position where the anterior markers are situated in the most anterior (12:00 o¿clock) position.The sidearm of the hemostatic valve may serve as an external reference to the fenestration(s) and/or scallop(s), anterior and posterior markers and body side markers".Caution: maintain wire guide position during delivery system insertions.Caution: to avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).There is no evidence to suggest that the user did not follow the instructions for use.Based on the information received, it is most likely that the device was twisted and not compressed symmetrically during the loading process.The loading team in manufacturing was notified about this reported event and a corrective action process has been initiated to further investigate this issue.Further actions will be taken as necessary.The mandatory requirement to always check complaints history during a complaint investigation will ensure trends are constantly monitored.After considering this event the benefits of using this device still outweigh the known risks.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY
• Common Device Name: 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: tia gibb ; 95 brandl street; eight mile plains; brisbane ; AS
• MDR Report Key: 18966645
• Report Number: 9680654-2024-00021
• Device Sequence Number: 17717018
• Product Code: MIH
• UDI-Device Identifier: 10827002325378
• UDI-Public: (01)10827002325378(17)270205(10)AC1152130
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P020018
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2024

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ZFEN-P-2-28-109-R
• Device Lot Number: AC1152130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 03/25/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown