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

Device Problems Complete Blockage (1094); Device Stenosis (4066)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/24/2021

Event Type  Injury  

Manufacturer Narrative

Device lot/serial information could not be obtained.Therefore, no manufacturing evaluation could be performed.The device remains in the patient.Consequently, a direct product analysis was not possible.Cause of the reported event cannot be established based on evaluation of the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.Cbas® heparin surface incorporates carmeda 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.

Event Description

The following publication was reviewed by gore: title: examination of cases of reocclusion and restenosis after viabahn placement source: dialysis vaivt 2022: 4() p.58-60 from may 2021 to october 2021, viabahn was placed in 24 cases for avg anastomotic stenosis at our hospital, and follow-up was possible in 22 cases.Two cases were excluded due to death.The observation period was 3 to 9 months after placement.12/22 cases with primary patency are group a, 6/22 cases with assisted primary patency are group b, and 4/22 cases with reconstruction are group c.In comparing group a and b, the number of cases was small and only a tendency was known, but the only cause leading to viabahn placement was stenosis in group a, and occlusion was common in group b, which can be said to be the difference.In addition, in this study, 11 of the 12 cases in group a were not able to get float at the tip of the viabahn, and the venous wall was in the state of apposition, and there were also cases who were placed near the venous valve.Due to the short observation period and the small number of cases, further investigation is considered necessary.(cuptured by mpdcase(b)(4).) case 1: a 73-year-old man.On (b)(6), placed viabahn for occlusion.Thrombectomy pta on (b)(6), but due to occlusion on (b)(6), he underwent a flow path change, thrombus removal, and pta twice, and then graft transplantation on (b)(6).(captured by mpdcase--(b)(4).) case 2: a 78-year-old woman.On (b)(6) vibahn was placed for stenosis, but on (b)(6) occluded, and reconstruction was performed.(captured by mpdcase-(b)(4).) case 3: 82-year-old male.On (b)(6), placed viabahn for occlusion, but on (b)(6) occluded.And reconstruction was performed.(captured by mpdcase-(b)(4).) case 4: a 76-year-old man.Avg was constructed at another hospital in (b)(6), and viabahn was placed at another hospital in (b)(6).On (b)(6), thrombectomy pta was performed, but viabahn was placed for occlusion on (b)(6), but occlusion occurred on the same day and thrombectomy was performed.Reocclusion occurred after thrombectomy for occlusion on (b)(6).(b)(6) thrombectomy, (b)(6) flow path change, (b)(6) thrombectomy, (b)(6) thrombectomy pta, viabahn placement, (b)(6) thrombectomy pta, (b)(6)thrombectomy pta, repeat occlusion occurred after viabahn placement.(captured by mpdcase-(b)(4).).

• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17159613
• MDR Text Key: 317584151
• Report Number: 2017233-2023-04040
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2023
• 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
• Date Manufacturer Received: 06/07/2023
• 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): Other; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male