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

Catalog Number UNKNOWN

Device Problems Device Slipped (1584); Material Twisted/Bent (2981)

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

Event Type  Injury  

Event Description

As initially reported to customer relations: jammeh, 2022 ¿anatomic characteristics associated with superior mesenteric artery stent graft placement during fenestrated para/suprarenal aneurysm repair¿ a total of 127 patients had undergone fevar with the zenith fenestrated endograft with from june 2012 to may 2020.34 (26.8%) had been treated with an sma scallop, 38 (29.9%) with an unstented sma fenestration, and 55 (43.3%) with a stent grafted sma fenestration sma stent graft placement was associated with a shorter infrarenal (1.73 +/- 6 1.18 mm) and infra-sma (16.9 6 +/-10.3 mm) neck length.The practice patterns had shifted significantly during the study period, with 86% of study participants treated with the zfen in the first year receiving a device with an sma scallop compared with only 13% in the final year.In contrast, the proportion of patients in the stent grafted sma fenestration group had increased from 14% to 50% between the first and final year of the study period.All patients had undergone preoperative imaging using cta to facilitate the production of customized proximal main body grafts with the appropriate alignments for fenestrations and/or scallops.In the sma stent graft group, 8- to 10-mm icast covered stents (atrium medical, hudson, nh) were used to line the fenestrations, and a balloon was flared at the orifice to create a seal between the bridging stent and main body.Only 8 of 69 patients (11.6%) had required brachial access for sma stent placement owing to steep, downward angulation.Each patient was treated with a device configured to include two small, reinforced fenestrations for the renal arteries and lined with icast covered stents.We will generally cannulate the sma branch first, followed by complete main body device deployment, balloon molding, and renal branch cannulation.The wire location relative to the stent struts can be evaluated with fluoroscopy, and any concerns regarding wire centrality can be further evaluated with 6-mm balloon inflation.At the conclusion of each procedure, aortography is performed to evaluate for endoleaks and confirm branch patency.No significant differences were found in the mean aneurysm size among the three cohorts (p ¼.79).The aortic diameter at the lower renal artery was significantly larger in the sma stent graft cohort than in the sma fenestration or sma scallop groups (30.8 6 6.8 mm vs 25.4 6 3.5 mm vs 26.1 6 4.2 mm; p ¼.01).The sma stent graft group had had a significantly shorter infrarenal neck length (1.73 6 1.2 mm vs 4.92 6 1.2 mm vs 6.28 6 1.4 mm; p ¼.03) and shorter infra-sma to proximal aneurysm distance (10.3 6 1.4 mm vs 23.8 6 1.2 mm vs 26.8 6 1.7 mm; p ¼.001).Technical success in the form of aneurysm exclusion with branch patency and no type i or iii endoleak on the completion angiogram was achieved in all patients.The sma stent graft group had had significantly longer operative times compared with the sma fenestration or sma scallop groups (335.5 +/- 16.4 minutes vs 265.0 +/- 12.8 minutes vs 269.0 +/- 12.7 minutes; p <.001; table ii).Likewise, the volume of blood loss (770 +/- 143 ml vs 303 +/- 35 ml vs 519 +/- 80 ml; p ¼.01) and transfusion rates (33% vs 8% vs 18%; p ¼.01) were higher in the sma stent graft group.However, no significant difference was found in the contrast volume administered (92.2 +/- 5.17 ml vs 87.1 +/- 6.73 ml vs 93.1 +/- 5.89 ml; p ¼.84), fluoroscopy time (65.4 +/- 3.76 minutes vs 58.3 +/- 3.94 minutes vs 51.4 +/- 4.75 minutes; p ¼.05), or radiation dose (3765 +/- 460 mgy vs 2694 +/- 323 mgy vs 4061 +/- 1188 mgy; p ¼.2).The length of hospital stay for the surviving patients ranged from 3 to 6 days without any significant differences across the three groups.All the patients were followed up with ct imaging at 1, 6, and 12 months, with annual follow-up thereafter.More recently treated patients were also followed up with renal and visceral duplex ultrasound to evaluate the stent grafts.Patients with chronic kidney disease were monitored with noncontrast-enhanced ct and concurrent abdominal duplex ultrasound for endoleak and renovisceral stent velocities.Reintervention with branch stent graft angioplasty or realignment was recommended for the patient with 50% stenosis.(b)(6): one patient (sma stent) had stent kinking which required lra stent distal extension.

Manufacturer Narrative

(b)(6) (same patient), (b)(6), and (b)(6) are related.Jammeh ml, sanchez la, ohman jw.Anatomic characteristics associated with superior mesenteric artery stent graft placement during fenestrated para/suprarenal aneurysm repair.J vasc surg.2022 jun;75(6):1837-1845.E1.

Manufacturer Narrative

No part of the device was returned for evaluation.No imaging was supplied to assist the investigation.No additional information was received, despite three requests being made.A review of device history record could not be completed as the lot number is unknown.The instructions for use supplied with the complaint device was reviewed and contains appropriate warnings and precautions for use.Based on the information provided a definitive root cause could not be determined from the investigation.Possible root causes are: incorrect sizing, inadequate radial outward forces provided by implant components, inadequate fixation, procedural/patient factors.

Event Description

As initially reported to customer relations: jammeh, 2022 ¿anatomic characteristics associated with superior mesenteric artery stent graft placement during fenestrated para/suprarenal aneurysm repair¿.A total of 127 patients had undergone fevar with the zenith fenestrated endograft with from june 2012 to may 2020.34 (26.8%) had been treated with an sma scallop, 38 (29.9%) with an unstented sma fenestration, and 55 (43.3%) with a stent grafted sma fenestration sma stent graft placement was associated with a shorter infrarenal (1.73 +/- 6 1.18 mm) and infra-sma (16.9 6 +/-10.3 mm) neck length.The practice patterns had shifted significantly during the study period, with 86% of study participants treated with the zfen in the first year receiving a device with an sma scallop compared with only 13% in the final year.In contrast, the proportion of patients in the stent grafted sma fenestration group had increased from 14% to 50% between the first and final year of the study period.All patients had undergone preoperative imaging using cta to facilitate the production of customized proximal main body grafts with the appropriate alignments for fenestrations and/or scallops.In the sma stent graft group, 8- to 10-mm icast covered stents (atrium medical, hudson, nh) were used to line the fenestrations, and a balloon was flared at the orifice to create a seal between the bridging stent and main body.Only 8 of 69 patients (11.6%) had required brachial access for sma stent placement owing to steep, downward angulation.Each patient was treated with a device configured to include two small, reinforced fenestrations for the renal arteries and lined with icast covered stents.We will generally cannulate the sma branch first, followed by complete main body device deployment, balloon molding, and renal branch cannulation.The wire location relative to the stent struts can be evaluated with fluoroscopy, and any concerns regarding wire centrality can be further evaluated with 6-mm balloon inflation.At the conclusion of each procedure, aortography is performed to evaluate for endoleaks and confirm branch patency.No significant differences were found in the mean aneurysm size among the three cohorts (p ¼.79).The aortic diameter at the lower renal artery was significantly larger in the sma stent graft cohort than in the sma fenestration or sma scallop groups (30.8 6 6.8 mm vs 25.4 6 3.5 mm vs 26.1 6 4.2 mm; p ¼.01).The sma stent graft group had had a significantly shorter infrarenal neck length (1.73 6 1.2 mm vs 4.92 6 1.2 mm vs 6.28 6 1.4 mm; p ¼.03) and shorter infra-sma to proximal aneurysm distance (10.3 6 1.4 mm vs 23.8 6 1.2 mm vs 26.8 6 1.7 mm; p ¼.001).Technical success in the form of aneurysm exclusion with branch patency and no type i or iii endoleak on the completion angiogram was achieved in all patients.The sma stent graft group had had significantly longer operative times compared with the sma fenestration or sma scallop groups (335.5 +/- 16.4 minutes vs 265.0 +/- 12.8 minutes vs 269.0 +/- 12.7 minutes; p <.001; table ii).Likewise, the volume of blood loss (770 +/- 143 ml vs 303 +/- 35 ml vs 519 +/- 80 ml; p ¼.01) and transfusion rates (33% vs 8% vs 18%; p ¼.01) were higher in the sma stent graft group.However, no significant difference was found in the contrast volume administered (92.2 +/- 5.17 ml vs 87.1 +/- 6.73 ml vs 93.1 +/- 5.89 ml; p ¼.84), fluoroscopy time (65.4 +/- 3.76 minutes vs 58.3 +/- 3.94 minutes vs 51.4 +/- 4.75 minutes; p ¼.05), or radiation dose (3765 +/- 460 mgy vs 2694 +/- 323 mgy vs 4061 +/- 1188 mgy; p ¼.2).The length of hospital stay for the surviving patients ranged from 3 to 6 days without any significant differences across the three groups.All the patients were followed up with ct imaging at 1, 6, and 12 months, with annual follow-up thereafter.More recently treated patients were also followed up with renal and visceral duplex ultrasound to evaluate the stent grafts.Patients with chronic kidney disease were monitored with noncontrast-enhanced ct and concurrent abdominal duplex ultrasound for endoleak and renovisceral stent velocities.Reintervention with branch stent graft angioplasty or realignment was recommended for the patient with 50% stenosis.(b)(4): one patient (sma stent) had stent kinking which required lra stent distal extension.

• Brand Name: ZENITH FENESTRATED GRAFT
• 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: 16200637
• MDR Text Key: 307675529
• Report Number: 9680654-2023-00010
• Device Sequence Number: 1
• Product Code: MIH
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2023

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 01/05/2023
• Supplement Dates FDA Received: 03/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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