MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problem Leak/Splash (1354)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 06/16/2022

Event Type  Injury  

Event Description

Justin george., et al."renovisceral stents in complex aortic grafts: assessing endoleaks, patency, and reintervention".A single-institution complex aortic aneurysm database was retrospectively reviewed for all fenestrated, branched, and parallel stent-graft cases from (b)(6) 2014 to (b)(6) 2021.Data on patient demographics, renovisceral stent-graft characteristics, and outcomes were collected and analyzed.Results: a total of 399 renovisceral stents were placed in 168 patients.The mean patient age was 74.5 years, and 77% were men.Of the 168 patients, 111 (66.1%) had received parallel stent-grafts and 57 (33.9%) had undergone fenestrated repair.Of the 399 stents, 58 were celiac artery, 90 were superior mesenteric artery (sma), and 251 were renal artery stents.The mean follow-up was 39.1 months.The 30-day mortality was 2.4% (n = 4).Aortic-related mortality was 2.4% (n = 4).The mean reintervention free survival was 34.3 months.Thrombosis occurred in three celiac artery (5.2%), four sma (4.4%), and nine renal artery (3.6%) stents.Gutter leaks were detected along three celiac artery (5.2%), one sma (1.1%), and seven renal artery (2.8%) stents.The use of viabahn stents in the celiac artery reinforced with bare metal stents (bmss) resulted in a statistically significant increase in gutter leaks (p =.02) and reintervention rates (p =.03).The use of covered stents with bms reinforcement in the renal arteries resulted in significantly increased development of gutter leaks (p<.01).Type ic endoleaks were detected in one celiac artery (1.7%), one sma (1.1%), and four renal artery (1.6%) stents.No type iiic endoleaks were detected.The reintervention rates were 8.6% for the celiac artery, 6.7% for the sma, and 7.6% for the renal artery stents.The article references gore® viabahn® vbx balloon expandable endoprosthesis being used during the cases from (b)(6) 2014 to (b)(6) 2021.

Manufacturer Narrative

Additional manufacturer narrative: cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Article: renovisceral stents in complex aortic grafts: assessing endoleaks, patency, and reintervention.Justin george, nicole ilonzo, kassandra carrion, shivani kumar, vivek prakash, rami tadros, james mckinsey, ajit rao, william e.Beckerman.Journal of vascular surgery.D4 serial number corrected to unknown.

Event Description

The following literature was reviewed: justin george., et al."renovisceral stents in complex aortic grafts: assessing endoleaks, patency, and reintervention." a single-institution complex aortic aneurysm database was retrospectively reviewed for all fenestrated, branched, and parallel stent-graft cases from august 1, 2014 to april 1, 2021.Data on patient demographics, renovisceral stent-graft characteristics, and outcomes were collected and analyzed.Results: a total of 399 renovisceral stents were placed in 168 patients.The mean patient age was 74.5 years, and 77% were men.Of the 168 patients, 111 (66.1%) had received parallel stent-grafts and 57 (33.9%) had undergone fenestrated repair.Of the 399 stents, 58 were celiac artery, 90 were superior mesenteric artery (sma), and 251 were renal artery stents.The mean follow-up was 39.1 months.The 30-day mortality was 2.4% (n = 4).Aortic-related mortality was 2.4% (n = 4).The mean reintervention free survival was 34.3 months.Thrombosis occurred in three celiac artery (5.2%), four sma (4.4%), and nine renal artery (3.6%) stents.Gutter leaks were detected along three celiac artery (5.2%), one sma (1.1%), and seven renal artery (2.8%) stents.The use of viabahn stents in the celiac artery reinforced with bare metal stents (bmss) resulted in a statistically significant increase in gutter leaks (p =.02) and reintervention rates (p =.03).The use of covered stents with bms reinforcement in the renal arteries resulted in significantly increased development of gutter leaks (p<.01).Type ic endoleaks were detected in one celiac artery (1.7%), one sma (1.1%), and four renal artery (1.6%) stents.No type iiic endoleaks were detected.The reintervention rates were 8.6% for the celiac artery, 6.7% for the sma, and 7.6% for the renal artery stents.The article references gore® viabahn® endoprosthesis being used during the cases from august 1, 2014 to april 1, 2021.

Manufacturer Narrative

Corrected b5 - event description (product).

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marcos ayala ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15032857
• MDR Text Key: 296045047
• Report Number: 2017233-2022-03128
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/15/2022
• Supplement Dates Manufacturer Received: 06/16/2022; 08/11/2022
• Supplement Dates FDA Received: 07/25/2022; 08/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male