MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE ILIAC; STENT, ILIAC

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

Patient Problems Reocclusion (1985); Renal Failure (2041)

Event Date 08/19/2020

Event Type  Injury  

Manufacturer Narrative

Journal title: use of stainless steel, balloon-expandable chimney grafts is durable though caution is required when lining angulated renal arteries title: journal of endovascular therapy year: 2020 ref: doi: 10.1177/1526602820948260.Average age, majority gender, date of publication.Journal reported death but there is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

This article presents a retrospective review of 116 elective patients who underwent chimney endovascular aneurysm repair (chevar) procedures and aims to analyse the overall performance of flexible nitinol stents used to line chimney grafts (cgs) chevar of pararenal pathologies.Of the devices used in this study, medtronic¿s endurant ii abdominal stent-graft was included.The cgs were preferably short to avoid an angulated segment within the target vessel, but a minimum 10-mm overlap between the aortic stentgraft and the cg had to be maintained.After deployment of the cgs, kissing balloon dilation was performed to ensure an adequate seal at the proximal neck and to minimize the gutters.After partial retraction of the stiff wire and intraoperative evaluation of the resulting cg angle, the need for an additional stent was evaluated, especially if the distal part of the cg impinged on the angulated segment of the target vessel.A bare nitinol stent was deployed to improve the flexibility and smooth the transition.Lining was performed to modulate the distal angulation and prevent kinking and stenosis.The use of self-expanding bare stents was preferred to covered stents in order to minimize lumen loss that comes with deploying an additional device.The uncovered stents used for lining included the medtronic¿s complete se.Both chimney stent-grafts and the lining stents were sized 1:1 relative to the native vessel diameter.Thus, a 6-mm cg was lined with a 6-mm bare metal stent, which was long enough to entirely overlap the cg.Depending on the angulation of the target vessel, the entire segment was covered by the self-expanding stent to improve the transition within the artery.The author reports the superior mesenteric artery (sma) has a characteristically straight trajectory not always present in the renal arteries.However, the indication for lining the sma was per se similar to the renal arteries.Three-dimensional (3d) reconstruction and centerline measurements of 1-mm-slice thoracoabdominal computed tomography angiography (cta) scans were performed preoperatively for planning and chevar feasibility analysis.Target renal artery angle measurements on the preoperative cta were performed in the multiplanar reconstruction mode based on the centerline for the present study.The results were compared with the angulation in the transverse, coronal, and sagittal views.A standard follow-up protocol was designed including 1-mm-slice thoracoabdominal cta at discharge, duplex ultrasound at 6 months, and cta at 12 months and then annually.If >5-mm aneurysm sac enlargement was detected by duplex, a dditional cta was performed.Patients with renal insufficiency (glomerular filtration rate 1.5 mg/dl) underwent either magnetic resonance angiography or cta using no more than 40 ml of contrast through a transbrachially placed aortic flush catheter.Criteria for r eintervention were symptoms of cg occlusion, such as lumbar pain or renal function impairment, and imaging-confirmed occlusion or >70% stenosis or kinking of the cg.Primary outcomes were cg patency and freedom from reintervention in the entire study cohort and a subgroup evaluation of the lined vs unlined cgs.Secondary outcomes included subgroup evaluation of cg patency in patients having single vs multiple cgs and analysis of potential confounders in occlusion risk.Stent patency, procedure-related success, and endoleaks were determined.Cg-related secondary procedures were defined as reinterventions due to cg occlusions or high-grade (>70%) stenosisconfirmed by angiography.Cg-related reinterventions included all secondary procedures for the treatment of type i, ii, iii, or gutter-related endoleaks, as well as surgical access complications, thrombosis of the iliac limbs, or internal bleeding.Over 9 years, 172 non-medtronic covered stents were used as cgs in the renovisceral vessels.Vessel lining was electively performed in 43 vessels of 32 patients.Thirty-day mortality was 1.7%.Both patients suffered from heart insufficiency and developed an acute coronary syndrome leading to multiorgan failure and death.Mean clinical follow-up was 33.8 months while imaging follow-up was 27.3 months.At th e end of follow-up, 27 of 116 patients died.Patient survival at last follow-up was 76.7%, with an estimated mean survival time of 71.4 months.The overall patency rate in patients with the non-medtronic covered stent was 92% at 1 year and 90.4% in the second and third years, respectively.The mean takeoff angle of the renal arteries was 33°±12°.The mean angle of the lined renal arteries was 44.2°±23°.Eight cg occlusions were observed during the entire follow-up period, 6 of which had been lined; 7 had occurred within the first year after surgery.The median occlusion time was 4.75 months.Multiple cgs had been placed in half of the occluded cases.Four of 8 occlusions were asymptomatic and incidentally detected on routine imaging, thus reintervention was not attempted.Successful cg rescue was achieved in 3 of 4 symptomatic cg occlusions using endovascular techniques in a left renal artery and a sma and an iliorenal bypass in the third case.All 3 successfully rescued renal cgs resulted in normalization of renal function.The other 5 patients had stage iii renal function impairment, but no cg occlusion led to hemodialysis.Estimated freedom from reintervention in the entire cohort was 87% at the end of the first year, 85% in the third year, and 76.0% at the end of the fourth year.Primary patency rates were 96.9% at 12 months in the unlined group vs 77.1% for the lined group, while the estimated freedom from reintervention was 87.6% and 83.4% for the unlined vs lined groups, respectively.Lining represented an independent risk factor for cg occlusion.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10546986
• MDR Text Key: 207730964
• Report Number: 9612164-2020-03495
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P090006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2020

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/17/2020
• 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
• Patient Age: 74 YR