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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.
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Manufacturer (Section D)
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key8116367
MDR Text Key128786577
Report Number2183870-2018-00549
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received11/29/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/29/2018 Patient Sequence Number: 1