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 Leak/Splash (1354); Material Separation (1562); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 05/20/2020

Event Type  Injury  

Event Description

The proximal graft and the distal graft separated creating a type 3 endoleak.Surgical intervention was required.The distal fenestrated component lost its overlap with the proximal fenestrated component.The distal component migrated down into the aneurysm at a difficult angle posteriorly.Also, the right and left iliac limbs lost seal within the common iliacs and migrated up into the aneurysm.The distal fenestrated graft and limbs folded in the aneurysm making reintervention difficult.Physician accessed the axillary artery and put a 8fr sheath down into the aorta.He stented the superior mesenteric artery with a gore 8x29 vbx and stented the left renal artery with a gore 6x29 vbx.He then drove a wire down into the proximal fenestrated graft.He was able to snake the wire into the distal graft and through the left iliac limb.The physician accessed both femoral arteries and then from the left side snared the wire from above.Once he had wire access he exchanged it to a stiff wire which helped straighten out the folded graft.He then accessed the patients right femoral artery with a wire and was able to get access into the aorta from both sides.He decided to reline the graft with a gore excluder graft.After the relining the grafts with the gore endografts an angiogram confirmed that the aneurysm was now sealed with no endoleak.

Event Description

The proximal graft and the distal graft separated creating a type 3 endoleak.Surgical intervention was required.The distal fenestrated component lost its overlap with the proximal fenestrated component.The distal component migrated down into the aneurysm at a difficult angle posteriorly.Also, the right and left iliac limbs lost seal within the common iliacs and migrated up into the aneurysm.The distal fenestrated graft and limbs folded in the aneurysm making reintervention difficult.Physician accessed the axillary artery and put a 8fr sheath down into the aorta.He stented the superior mesenteric artery with a gore 8x29 vbx and stented the left renal artery with a gore 6x29 vbx.He then drove a wire down into the proximal fenenstrated graft.He was able to snake the wire into the distal graft and through the left iliac limb.The physician accessed both femoral arteries and then from the left side snared the wire from above.Once he had wire access he exchanged it to a stiff wire which helped straighten out the folded graft.He then accessed the patients right femoral artery with a wire and was able to get access into the aorta from both sides.He decided to reline the graft with a gore excluder graft.After the relining the grafts with the gore endografts an angiogram confirmed that the aneurysm was now sealed with no endoleak.

Manufacturer Narrative

The device was not returned for evaluation.Additional information was received: patient was in hospital for 7 days then released.Upon reviewing imaging available for this complaint medical director stated "the endograft device failed due to loss of overlap and subsequent separation." the work order ac1006353 appears complete and correct.The graft appears to be manufactured as per the approved physician order.The device ifu states that the long-term performance of fenestrated endovascular grafts, including the stents placed in fenestrations/scallops, has not yet been established, and all patients should be advised that endovascular treatment requires life-long, regular follow-up to assess their health and the performance of their endovascular graft.Potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak, component migration.Based on the information provided, the root cause is unknown.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 factors.

• 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
• MDR Report Key: 10126672
• MDR Text Key: 197760244
• Report Number: 9680654-2020-00023
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 10827002325514
• UDI-Public: (01)10827002325514(17)201103(10)AC1006353
• 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
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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: 11/03/2020
• Device Model Number: G32551
• Device Catalogue Number: ZFEN-D-12-28-76-C
• Device Lot Number: AC1006353
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/26/2020
• Initial Date FDA Received: 06/07/2020
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR