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 Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Ischemia (1942); Myocardial Infarction (1969); Spinal Cord Injury (2432); Paraplegia (2448); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446)

Event Type  Injury  

Event Description

Two-hundred-sixty (260) patients enrolled between june of 2010 and january of 2015 in prospective nonerandomized physician-sponsored investigational device exemption protocols or with commercially available zenith fenestrated stent grafts.Early experience included consecutive patients treated between june 2010 and december 2013, whereas late experience included successive patients treated between december 2013 and january 2015.Group 1 consisted of 1 or 2 fenestrations or branches, group 2 had 3 vessels incorporated, and group 3 had at least 4 vessels incorporated.A total of 830 vessels (mean, 3.19 ± 0.8 vessels/patient) were targeted by fenestrations (n = 672), scallops (n = 136), or branches (n = 22).The most common device configurations consisted of two fenestrations and one scallop for 79 patients (30%) followed by 3 fenestrations in 50 patients (19%), and 4 fenestrations in 44 patients (17%).Total operative time and fluoroscopy time increased significantly from group 1 to group 2 and group 1 to group 3, but there was no difference between group 2 to group 3.Contrast volume increased with increasing number of vessels incorporated from group 1 to groups 2 and 3.Technical success was 99.6% for the entire cohort of patients with only one patient treated by 4 fenestrations who had technical failure due to renal artery disruption requiring coil embolization.There was no difference in technical success and ebl between groups.The median length of hospital stay was 3 days (iqr 2-5 days), and the median of intensive care was 1 day (iqr 0-2 days).The length of hospital stay and intensive care unit were significantly higher among patients in group 3 than group 1.Surgical team late experience: group 1: 41 patients group 2: 37 patients group 3: 52 patients incorporated renal mesenteric vessels (mean ± sd): group 1: 2.64 ± 0.59 group 2: 3.4 ± 0.49 group 3: 4.11 ± 0.31 fenestrated or branched vessels (mean ± sd): group 1: 1.82 ± 0.44 group 2: 3.0 group 3: 4.07 ± 0.26 total or time (min) (mean ± sd): group 1: 204 ± 77.5 group 2: 249 ± 116.1 group 3: 282 ± 81.2 fluoroscopy time (min) (mean ± sd): group 1: 58 ± 22.9 group 2: 80 ± 45.0 group 3: 85 ± 31.0 total contrast (ml) (mean ± sd): group 1: 91 ± 36.1 group 2: 104 ± 41.6 group 3: 122 ± 43.5 aorta coverage (mm) (mean ± sd): group 1: 147 ± 33 group 2: 199 ± 102 group 3: 201 ± 37 supraceliac coverage (mm) (median (iqr)): group 1: 0 (0-0) group 2: 0 (0-10) group 3: 38 (27-50) technical success, n (%): group 1: 124 (100) group 2: 80 (100) group 3: 55 (98) type ia endoleak ¿ completion angiogram, n (%): group 1: 7 group 2: 1 group 3: 0 ebl (ml) (mean ± sd): group 1: 373 ± 342 group 2: 458 ± 352 group 3: 397 ± 294 this pr395096: this pr covers 31 cases of adverse physiological responses.- major adverse event.Seven patients in total had myocardial infarction.There were 3 patients in group 2 and 4 patients in group 3.- major adverse event.Seven patients had respiratory failure.There were 3 patients in group 1, 1 patient in group 2, and 3 patients in group 3.- major adverse event.Two patients developed paraplegia.There was 1 patient in group 2 and 1 patient in group 3.- major adverse event.One patient had a stroke.The patient was in group 3.- major adverse event.Nine patients had bowel ischemia.There were 2 patients in group 1, 4 patient in group 2, and 3 patients in group 3.- three patients had congestive heart failure.There was 1 patient in group 1, 1 patient in group 2, and 1 patient in group 3.- two patients developed spinal cord injury.There was 1 patient in group 2 and 1 patient in group 3.Both patients became ambulatory at 3 months.

Manufacturer Narrative

Banga p, oderich gs, farber m, et al.Impact of number of vessels targeted on outcomes of fenestrated-branched endovascular repair for complex abdominal aortic aneurysms.Ann vasc surg.2021;72:98-105.Doi:(b)(4).Prs (b)(4) are related.Although the article under the section "device design" states the devices being used were: "patient-specific zenith manufactured fenestrated and branched stent grafts", the "methods" section indicates that the devices being used were either physician-sponsored investigational device exemption protocols or commercially available zenith fenestrated stent grafts.As there is no indication in the article to the fraction of patients receiving cmds or zfens, all events have been reported for zfens out of an abundance of caution.

Event Description

Two-hundred-sixty (260) patients enrolled between (b)(6) 2010 and (b)(6) 2015 in prospective nonerandomized physician-sponsored investigational device exemption protocols or with commercially available zenith fenestrated stent grafts.Early experience included consecutive patients treated between (b)(6): 2010 and (b)(6) 2013, whereas late experience included successive patients treated between (b)(6) 2013 and (b)(6): 2015.Group 1 consisted of 1 or 2 fenestrations or branches, group 2 had 3 vessels incorporated, and group 3 had at least 4 vessels incorporated.A total of (b)(4): vessels (mean, 3.19 ± 0.8 vessels/patient) were targeted by fenestrations (n = 672), scallops (n = 136), or branches (n = 22).The most common device configurations consisted of two fenestrations and one scallop for 79 patients (30%) followed by 3 fenestrations in 50 patients (19%), and 4 fenestrations in 44 patients (17%).Total operative time and fluoroscopy time increased significantly from group 1 to group 2 and group 1 to group 3, but there was no difference between group 2 to group 3.Contrast volume increased with increasing number of vessels incorporated from group 1 to groups 2 and 3.Technical success was 99.6% for the entire cohort of patients with only one patient treated by 4 fenestrations who had technical failure due to renal artery disruption requiring coil embolization.There was no difference in technical success and ebl between groups.The median length of hospital stay was 3 days (iqr 2-5 days), and the median of intensive care was 1 day (iqr 0-2 days).The length of hospital stay and intensive care unit were significantly higher among patients in group 3 than group 1.Surgical team late experience: group 1: 41 patients, group 2: 37 patients, group 3: 52 patients.Incorporated renal mesenteric vessels (mean ± sd): group 1: 2.64 ± 0.59, group 2: 3.4 ± 0.49, group 3: 4.11 ± 0.31.Fenestrated or branched vessels (mean ± sd): group 1: 1.82 ± 0.44 , group 2: 3.0 , group 3: 4.07 ± 0.26.Total or time (min) (mean ± sd): group 1: 204 ± 77.5 , group 2: 249 ± 116.1, group 3: 282 ± 81.2.Fluoroscopy time (min) (mean ± sd): group 1: 58 ± 22.9 , group 2: 80 ± 45.0 , group 3: 85 ± 31.0.Total contrast (ml) (mean ± sd): group 1: 91 ± 36.1, group 2: 104 ± 41.6 , group 3: 122 ± 43.5.Aorta coverage (mm) (mean ± sd): group 1: 147 ± 33, group 2: 199 ± 102, group 3: 201 ± 37.Supraceliac coverage (mm) (median (iqr)): group 1: 0 (0-0), group 2: 0 (0-10), group 3: 38 (27-50).Technical success, n (%): group 1: 124 (100), group 2: 80 (100) , group 3: 55 (98).Type ia endoleak ¿ completion angiogram, n (%): group 1: 7 , group 2: 1, group 3: 0.Ebl (ml) (mean ± sd): group 1: 373 ± 342 , group 2: 458 ± 352, group 3: 397 ± 294.This (b)(6): : this pr covers 31 cases of adverse physiological responses.- major adverse event.Seven patients in total had myocardial infarction.There were 3 patients in group 2 and 4 patients in group 3.- major adverse event.Seven patients had respiratory failure.There were 3 patients in group 1, 1 patient in group 2, and 3 patients in group 3.- major adverse event.Two patients developed paraplegia.There was 1 patient in group 2 and 1 patient in group 3.- major adverse event.One patient had a stroke.The patient was in group 3.- major adverse event.Nine patients had bowel ischemia.There were 2 patients in group 1, 4 patient in group 2, and 3 patients in group 3.- three patients had congestive heart failure.There was 1 patient in group 1, 1 patient in group 2, and 1 patient in group 3.- two patients developed spinal cord injury.There was 1 patient in group 2 and 1 patient in group 3.Both patients became ambulatory at 3 months.There was no difference in 30-day mortality between patients treated in group 1, group 2, and group 3 (0.8% vs.2.5% vs.1.9%, p ¼ 0.76).Any morbidity was also similar in group 1 (10.5%, 13/124), group 2 (17.7%, 14/80), and group 3 (17.9%, 10/56; p ¼ 0.23).There were four 30-day or in-hospital deaths in the entire cohort (1.5%).

Manufacturer Narrative

The device was not returned for evaluation.No imaging was received to assist with the investigation.Additional information was requested but no information was received.The device history record could not be reviewed as the lot numbers are unknown.Review of the general information from the instructions for use (ifu) likely supplied with the device found that it contains information relating to patient selection, potential adverse events and warnings and precautions.There is no evidence to suggest that the user did not follow the ifu.From the information received it is difficult to determine a definitive root cause for the reported events.The reported events are known effects of failure listed in the ifu.Should additional information be received at any time in the future the investigation may be updated, and an additional report may be supplied.

• 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): COOK AUSTRALIA; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• Manufacturer Contact: majbrit frosig ; brisbane technology park; 95 brandl street; eight mile plains, qld ; AS
• MDR Report Key: 17402039
• MDR Text Key: 319918322
• Report Number: 9680654-2023-00090
• 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: 08/17/2023

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: 07/25/2023
• Initial Date FDA Received: 07/26/2023
• Supplement Dates Manufacturer Received: 07/25/2023
• Supplement Dates FDA Received: 08/16/2023
• 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): Other