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

Catalog Number PAHR070502E

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

Patient Problems Renal Failure (2041); Thrombosis/Thrombus (4440)

Event Date 07/25/2022

Event Type  Injury  

Manufacturer Narrative

Note: vbx device occlusions, onset date september 15, 2020, were reported to fda with manufacturer report numbers 2017233-2020-01381 and 2017233-2020-01382 previously.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains implanted and was therefore not available for engineering evaluation.The physician reported that the patient had self-discontinued his antiplatelet drugs one week before he was admitted to the hospital.He further reported that the patient had an infection that was unrelated to the implanted devices and that the patient has drunk to little.The doctor suspected that all of this combined to cause the re-occlusion.Therefore the most probable root cause of the reported occlusion is considered to be related to patient condition.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

On (b)(6) 2020, the patient underwent a branched endovascular aortic repair (bevar) to treat a thoracoabdominal aneurysm type iv with a customized fenestrated / branched stent graft component (cook medical).Three gore® viabahn® vbx balloon expandable endoprostheses (vbx device) were implanted via a cut-down to the left axillary artery to extend the branches into the left renal artery, the right renal artery and the superior mesenteric artery (sma).All viabahn vbx devices were navigated to their intended locations and deployed without issues.At the end of the procedure all viabahn vbx devices were patent.On september 15, 2020, endovascular thrombectomy was performed to treat occlusion of the vbx devices implanted in the renal arteries (reported to fda with manufacturer report numbers 2017233-2020-01381 and 2017233-2020-01382).Both renal artery were relined distally with a gore® viabahn® endoprosthesis (viabahn device) with propaten bioactive surface and proximally with a begraft+ aortic stent graft (bentley).On (b)(6) 2022, the patient was admitted to the hospital as an emergency case.He presented with renal failure because of re-occlusion of the vbx devices and the viabahn devices implanted in the left and right renal artery.The onset date of the occlusion remains unknown.The physician reported that the patient had self-discontinued his antiplatelet drugs one week before he was admitted to the hospital.He further reported that the patient had an infection that was unrelated to the implanted devices and that the patient has drunk to little.The doctor suspected that all of this combined to cause the re-occlusion.On (b)(6) 2022, an endovascular reintervention was performed to treat the occlusions.After cannulation of the left renal artery, they performed a pulse-spray-lysis (16 mg actilysis).Remaining thrombus was partially resolved with thrombectomy.After this the left kidney was re-perfused.Residual thrombus in the proximal part of the previous implanted stent was relined with a vbx device, and a high-grade stenosis at the transition into the renal hilum was treated with a short dynamic renal stent (biotronik).Then they cannulated the right renal artery and performed a pulse-spray-lysis (23 mg actilysis).After a single passage, the right kidney was re-perfused with minimal residual thrombus in the proximal part of the previous implanted stent which was relined with a short viabahn device.Final angiography control showed that both kidneys were perfused.It was reported that the patient tolerated the procedure and is doing well.

Manufacturer Narrative

Conclusion a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The device remains implanted and was therefore not available for engineering evaluation.The available information reported in the complaint does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.The reported information indicated suspected cause for device occlusion was related to irregular antiplatelet drug therapy and non-device related infection.The viabahn device ifu states the following: "failure or inability to use appropriate anticoagulant and/or antiplatelet therapy prior to, during, and following the procedure may lead to thrombotic occlusions, potentially requiring surgery." the ifu also states: "following endovascular treatment of patients using the gore® viabahn® endoprosthesis with propaten bioactive surface, anticoagulant and/or antiplatelet therapy is recommended at a dosage deemed appropriate by the physician.".

Manufacturer Narrative

Sections d2 (code) and g4 (pma/510(k) number have been corrected.

• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15277149
• MDR Text Key: 298416535
• Report Number: 2017233-2022-03266
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2023
• Device Catalogue Number: PAHR070502E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/11/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 78 KG