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

Model Number G32551

Device Problems Material Separation (1562); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Approximately three years post implant, the bifurcated graft separated from the tube graft.The physician had to reline the endograft.

Manufacturer Narrative

No part of the device was returned for evaluation.The medical director who reviewed the imaging provided stated "the grafts were implanted in (b)(6) 2019, and an early post-op ct scan shows a good overlap of almost 3 full stents at that time, between the zfen-p and the zfen-d.3 years later, on (b)(6) 2022, the ct shows that the zfen-d has pulled out of the zfen-p, resulting in a large type 3 endoleak.The aaa is large in diameter, and the grafts have ¿bowed¿ resulting in the separation.Fortunately, the surgeon was able to bridge the separation gap by relining it.This case is a separation between the two main graft components.It is device-related, due to the same diameter fit at the overlap between the two components, combined with the presence of a large aneurysm.The endograft gradually works its way across the aneurysm and comes to lie against the wall of the aneurysm.This horizontal movement over time results in the distal component pulling out of the proximal one, which is held in place by its bridging stents.In summary ¿ this is a case of graft separation almost certainly caused by the slip fit between the two main graft components at the overlap, despite a good 3-stent overlap at the time of implant".Additional information was received as follows: additional products used during the implant procedure: tube graft g32549, lot ac1028670, cook coda balloon.The instructions for use (ifu) were followed during the implant procedure, no issue during implant.Ballooning was performed on the top 2 seal stents of proximal piece, overlap zone of bifurcated graft inside of proximal piece, and distal seal zone in each common iliac.The patient was on intraoperative heparin.The type iii endoleak was between bifurcated and proximal grafts.No separation was noted between the distal graft and leg graft.Covered stents were placed in the renal arteries through the small fenestrations.1/3 overlap of the covered stent was left inside the aorta.The intra-aortic segment of the covered stent was flared with an oversized angioplasty balloon.The implanted graft/stent migrated over time.There was clear separation between graft components.Regular follow up scans were done as per ifu.The migration was found on scans, which made reintervention necessary.There was no evidence of twisting of the grafts within graft components.Work order (b)(4) was reviewed for 1 x zfen-d-12-28-76-c and appears complete and correct.The associated inspection record confirms that the device was manufactured to specification, prior to shipment.Based on the information provided, and review of the provided imaging, a definitive root cause could not be determined.It is possible that the separation was due to: - insufficient fixation (friction) between the proximal and distal components - inadequate retention forces.- distal device separation.- patient-related anatomy factors.

Event Description

Approximately three years post implant, the bifurcated graft separated from the tube graft.The physician had to reline the endograft.

• Brand Name: ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT DISTAL BIFURCATED 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 QLD 4 113; AS QLD 4113
• Manufacturer (Section G): WILLIAM A. COOK AUSTRALIA, PTY LTD; 95 brandl street; eight mile plains; brisbane QLD 4 113; AS QLD 4113
• Manufacturer Contact: tia gibb ; 95 brandl street; eight mile plains; brisbane QLD 4-113 ; AS QLD 4113
• MDR Report Key: 14018502
• MDR Text Key: 288658348
• Report Number: 9680654-2022-00006
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)200808(10)AC1001202
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 06/16/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2020
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1001202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2017
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male