MAUDE Adverse Event Report: COVIDIEN EVERCROSS 035; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA

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

Patient Problems Vascular Dissection (3160); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 11/01/2018

Event Type  Injury  

Event Description

Medtronic received and article on the feasibility and the outcomes of transjugular percutaneous endovascular treatment of dysfunctional hemodialysis access in patients with chronic kidney disease.50 transjugular treatments in 38 patients with arteriovenous fistulas or arteriovenous grafts from september 2011 to may 2015 were included in this study.Medical records and angiographies were retrospectively reviewed.Success rate, patency rate, procedure time, and complications including internal jugular vein stenosis were evaluated.The stenotic segment was dilated with an angioplasty balloon that was 10%¿20% larger than the diameter of the normal segment.In native avf including immature avf, a 3- to 7-mm balloon (evercross and 2 non-medtronic) was used in juxtaanastomotic and arterial anastomotic stenosis.A 3- to 14-mm balloon (evercross and 2 non-medtronic) was used for outflow vein stenosis.In immature avfs, if any accessory vein greater than one-third of the main fistula vein was identified following angioplasty with sufficient dilation of the stenosis, it was obliterated by coil embolization.In non-thrombosed avgs, a 3- to 6-mm balloon (evercross and 2 non-medtronic) was used for arterial anastomotic stenosis and a 6- to 8-mm balloon (evercross and 2 non-medtronic) was used for venous anastomotic stenosis and intra-graft stenosis.The balloon was inflated until complete effacement of the balloon waist, and balloon inflation was maintained for at least 2 min at 15¿30 atm.In cases of stenosis resistant to high-pressure balloon angioplasty, an additional cutting balloon angioplasty was done, followed by high-pressure balloon angioplasty.The final fistulography was performed, and manual compression at the puncture site of the ijv was applied.A total of 50 sessions of transjugular treatments were performed in 38 patients.Among a total of 50 cases, there were 31 native avfs and 19 avgs.There were 2 cases of thrombosed avfs (1 radiocephalic and 1 brachiocephalic) and 6 cases of thrombosed avgs (4 brachioaxillary and 2 brachiobasilic).There were 10 immature avfs (4 radiocephalic and 6 brachiocephalic) and no cases of thrombosed immature avf.The number of stenotic sites was 1 in 13 cases, 2 in 19 cases, and more than 3 in 18 cases.Among the 50 procedures, the technical success rate was 90% (n = 45/50) and the clinical success rate was 88% (n = 44/50).The conventional approach was performed in 4 of 5 technical failure cases (juxta-anastomotic segment stenosis in 3 brachiocephalic avfs and venous graft anastomotic stenosis in 1 brachioaxillary avg) due to severe stenosis.The other technical failure (radiocephalic avf) was due to dissection and thrombosis in the draining vein during the procedure, and an operation was performed.Primary and secondary patency rates were calculated for 32 patients who experienced clinical success.The primary patency rate was 77% at 6 months and 60% at 1 year.The secondary patency rate was 97% at 6 months and 93% at 1 year.Major complications occurred in three cases.In one case of radiocephalic avf, the procedure was stopped due to dissection and throm bosis and the patient underwent a surgical operation.Perforation occurred during conventional pta after transjugular approach failure in two brachiocephalic avfs with a severe, tight juxta-anastomotic stenosis, which was managed by balloon tamponade or manual compression; one patient underwent a graft interposition operation immediately after the procedure, while the other underwent non-tunneled hemodialysis catheter insertion.No complications occurred at the puncture site of the ijv.For the evaluation of ijv stenosis, follow-up venography or doppler us was performed for 21 patients.No newly developed stenosis was detected among the patients on follow-up by venography or doppler us.The mean ijv stenosis follow-up time using venography or doppler us was 19.3 (range, 0.2¿37.5) months.

Manufacturer Narrative

Age: average age, sex: majority sex.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERCROSS 035
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14955742
• MDR Text Key: 295480887
• Report Number: 2183870-2022-00223
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K082579
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/08/2022

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
• Initial Date Manufacturer Received: 06/15/2022
• Initial Date FDA Received: 07/08/2022
• 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: 68 YR
• Patient Sex: Male