MAUDE Adverse Event Report: COVIDEN GOOSENECK SNARE; CATHETER, PERCUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 04/26/2018

Event Type  Death  

Manufacturer Narrative

April 26, 2018 - date of published article."procedural and perioperative results in patients treated with fenestrated endovascular aneurysm repair planned by automated software in a physician-sponsored investigational device exemption trial of physician-modified endografts," journal of vascular surgery (2018), volume 68, issue 5, pages 1297¿1307.10.1016/j.Jvs.2018.02.045.If information is provided in the future, a supplemental report will be issued.

Event Description

Objective: fenestrated endovascular aneurysm repair (fevar) has been used successfully to treat patients with juxtarenal abdominal aortic aneurysms (jaaas).Barriers to wide adoption of fevar include complexity in planning of fenestration locations on endografts.The purpose of this study was to validate the use of automated planning software to design fenestrated endografts and to treat patients with complex abdominal aortic aneurysms.Consented patients presenting with symptomatic or asymptomatic jaaa were implanted with a physician-modified fenestrated endograft (index procedure) and followed up with clinical and imaging data at 30 days, 6 months, 12 months, and annually thereafter through 5 years.Procedural (index procedure) and perioperative (30-day) data of the first 30 patients in the automated planning arm are presented here.Procedural (index procedure) and perioperative (30-day) data were collected and are reported here.The primary safety end point for the study is defined as the proportion of patients who experience a major adverse event (mae) within 30 days of the implant procedure.Ae¿s reported were death, myocardial infarction, stroke, renal failure, respiratory failure, paralysis, bowel ischemia, and procedural blood loss of >1 l, myocardial infarction, renal failure, and respiratory failure.Results: thirty consecutive patients were enrolled into the automated planning arm of the ongoing physician sponsored ide trial from february 2016, the time the software was approved for use in the study, through august 2017.These patients are in addition to those who were already enrolled in the manual planning arm of the study beginning in 2011.Two additional patients were successfully treated in the manual planning arm.All 30 patients (100%) who had grafts planned by the automated software and modified by the surgeon were successfully implanted.A total of 87 fenestrations were made for 30 smas and 57 renal arteries with an average of 2.9 fenestrations per patient.Endografts for all patients had an sma fenestration, and all but three had bilateral renal fenestrations.In those three patients, only a single renal artery was patent on baseline ct; thus, only a single renal artery fenestration was made.Three patients (10%) had the sma stented for underlying stenosis, and renal arteries were stented whenever possible (95%).Two patients died a few weeks after the index procedure but within the first 30 days.Neither death was directly due to the underlying aaa, but the procedure cannot be ruled out as contributory.The first patient died of complications from existing chronic obstructive pulmonary disease.The second patient died of a brain hemorrhage.A total of five patients (16.7%) experienced a mae within the first 30 days.It was reported that one of the fenestrations in a patient failed to open during deployment as it was located at a kinked portion of the endograft.In another patient the fenestration failed to open because it was located in a folded or kinked part of the graft.The 30-day ct scan showed evidence of contrast material trickling through the fenestration into the renal artery, suggesting reasonable alignment between the fenestration and the vessel ostium, although the fenestration was twisted and partially collapsed.

• Brand Name: GOOSENECK SNARE
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COVIDEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8116367
• MDR Text Key: 128786577
• Report Number: 2183870-2018-00549
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2018
• 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): Death
• Patient Age: 74 YR