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

Device Problem Complete Blockage (1094)

Patient Problem Occlusion (1984)

Event Date 02/03/2020

Event Type  Injury  

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.

Event Description

The following information was reported to gore: in an article titled "short-term outcomes of the t-branch off-the-shelf multibranched stent graft for reintervention after previous infrarenal aortic repair" it states the following: a retrospective two-center study was undertaken.All consecutive patients who underwent endovascular repair using t-branch stent graft after previous infrarenal aortic repair between january 2010 and august 2018 were included.Demographics, past medical history, cardiovascular risk factors, and intraoperative and perioperative details were recorded.Technical success and early (30-day) mortality, morbidity, target vessel patency, and presence of endoleak were analyzed.During the first year of follow-up, survival, freedom from reintervention, and patency rates were recorded.Gore® viabahn® endoprostheses and gore® viabahn® vbx balloon expandable endoprostheses were used as branch grafts in the study as well as non-gore devices.One patient developed target artery instability (type ic endoleak) at the distal branch attachment of the superior mesenteric artery stent that had been bridged using a gore® viabahn® endoprosthesis.This led to a reintervention.(reported separately pt.434-1).Additionally, three target vessels occluded at 12 months post implant: 1 celiac artery (reported separately pt.434-3), 1 superior mesenteric artery (this report-pat.434-2), 1 right renal artery (reported separately pt.434-4).

Event Description

Describe event or problem: the following information was reported to gore: in an article titled "short-term outcomes of the t - branch off - the - shelf multibranched stent graft for reintervention after previous infrarenal aortic repair" it states the following: a retrospective two-center study was undertaken.All consecutive patients who underwent endovascular repair using t-branch stent graft after previous infrarenal aortic repair between january 2010 and august 2018 were included.Demographics, past medical history, cardiovascular risk factors, and intraoperative and perioperative details were recorded.Technical success and early (30-day) mortality, morbidity, target vessel patency, and presence of endoleak were analyzed.During the first year of follow-up, survival, freedom from reintervention, and patency rates were recorded.Gore® viabahn® endoprostheses and gore® viabahn® vbx balloon expandable endoprostheses were used as branch grafts in the study as well as non-gore devices.One patient developed target artery instability (type ic endoleak) at the distal branch attachment of the superior mesenteric artery stent that had been bridged using a gore® viabahn® endoprosthesis.This led to a reintervention.(reported separately pt.434-1).Additionally, three target vessels occluded at 12 months post implant: 1 celiac artery, 1 superior mesenteric artery, 1 right renal artery.The three target vessel occlusions potentially involving gore® viabahn® vbx balloon expandable endoprostheses are being reported under case 434-3.Relevant tests / laboratory data, including dates.This patient's lab values were not given but the study group values as a whole were as follows: serum creatinine concentration, mg/dl 1.5 6 1.4 (1.1, 0.9-1.6).Egfr, ml / min / 1.73 m2 58 6 23 (57, 40-76).Body mass index, kg/m2 27 6 3 (26, 24-30).

Manufacturer Narrative

B.5.Updated.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 10388090
• MDR Text Key: 203107333
• Report Number: 2017233-2020-01100
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P40037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR