GORE VIABAHN Endoprosthesis with Heparin VBJR061502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00733132623747), received between Feb 28, 2019 and May 21, 2026 — classified as 5 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (9 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR TREATMENT OF A STENOTIC SUPERFICIAL FEMORAL ARTERY (SFA) WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED. THE PHYSICIAN REACHED THE TARGET TREATMENT AREA GOING THROUGH A TERUMO 7F DESTINATION¿ GUIDING SHEATH AND OVER AN 0.018" TERUMO GLIDEWIRE ADVANTAGE® WITHOUT ANY RESISTANCE. THE PHYSICIAN INITIATED DEPLOYMENT BY PULLING THE DEPLOYMENT LINE ALL THE WAY, HOWEVER, THE VIABAHN DEVICE DID NOT DEPLOY AS INTENDED. THE DEPLOYMENT LINE WAS NOT PULLED TOO HARD NOR TOO FAST. THE DEVICE WAS SUBSEQUENTLY WITHDRAWN FROM THE PATIENT THROUGH THE SHEATH, NO DEVICE EXPANSION WAS NOTED. THE PROCEDURE WAS COMPLETED USING AN NEW VIABAHN DEVICE. THERE WERE NO REPORTS OF PATIENT HARM, AND THE PATIENT IS REPORTED TO BE DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244034 ↗
• MalfunctionMar 10, 2026Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE INVOLVING THE SUPERFICIAL FEMORAL ARTERY (SFA) FOR AN UNKNOWN ETIOLOGY. DURING THE PROCEDURE, THE DELIVERY CATHETER ADVANCED NORMALLY VIA AN UP-AND-OVER CONTRALATERAL APPROACH USING A 6F INTRODUCER SHEATH FROM AN UNSPECIFIED MANUFACTURER OVER AN 0.018" GLIDEWIRE ADVANTAGE AND TO THE INTENDED TREATMENT LOCATION. WHEN ATTEMPTING TO DEPLOY THE DEVICE, THE OPERATOR WAS UNABLE TO INITIATE DEPLOYMENT; THE DEPLOYMENT LINE APPEARED STUCK. THE SYSTEM WAS SUBSEQUENTLY WITHDRAWN WITHOUT RESISTANCE, AND THE ENDOPROSTHESIS REMAINED FULLY CONSTRAINED UPON REMOVAL. REPORTEDLY, THERE WAS AN UNSUCCESSFUL ATTEMPT TO DEPLOY THE ENDOPROSTHESIS ON THE BACK TABLE. THE EVENT HAD NO REPORTED IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24560038 ↗
• MalfunctionDec 15, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO RELINE A STENT (BRAND UNKNOWN) THAT HAD THROMBOSED IN THE SUPERFICIAL FEMORAL ARTERY UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (GORE® VIABAHN® DEVICE). DURING THE PROCEDURE, THE DELIVERY SYSTEM CATHETER ADVANCED THROUGH A 6F COOK INTRODUCER SHEATH OVER AN UNSPECIFIED BRAND .018"GUIDEWIRE TO THE TARGET TREATMENT SITE. IT WAS REPORTED, TRACKING THROUGH THE INTRODUCER SHEATH WAS UNREMARKABLE. DURING DEPLOYMENT, THE DEPLOYMENT LINE WAS PULLED BUT THE ENDOPROSTHESIS FAILED TO RELEASE FROM THE DEPLOYMENT MECHANISM AS INTENDED. EXCESS FORCE WAS APPLIED, HOWEVER THE ENDOPROSTHESIS WOULD NOT RELEASE. IT WAS REPORTED THERE WAS NO DISTAL EXPANSION INITIATED FROM THE ATTEMPTED DEPLOYMENT, AND THE DEPLOYMENT LINE DID NOT BREAK. TO MITIGATE ANY ASSOCIATED RISK, THE SYSTEM CATHETER WAS WITHDRAWN FROM THE PATIENT. IT WAS REPORTED INTACT. ADDITIONAL GORE® VIABAHN® DEVICES WERE ADVANCED AND DEPLOYED SUCCESSFULLY DURING THE PROCEDURE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23803061 ↗
• MalfunctionOct 27, 2025Difficult or Delayed Activation; Difficult or Delayed Activation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT PRESENTED FOR TREATMENT OF AN IN-STENT STENOSIS. AS REPORTED, THERE WAS A PRE-EXISTING BARE METAL STENT (BMS). DURING DEPLOYMENT OF THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE), THE DEPLOYMENT LINE UNRAVELED UNTIL ABOUT ONE (1) CM OF THE VIABAHN® DEVICE REMAINED CONSTRAINED. IN ORDER TO FULLY EXPAND THE VIABAHN® DEVICE, BALLOON CATHETERS (UNSPECIFIED MANUFACTURER) WERE USED. EVENTUALLY, THE VIABAHN® DEVICE WAS FULLY EXPANDED AND THE DEPLOYMENT LINE WAS REMOVED WITH THE CATHETER. THE PHYSICIAN SUSPECTS THE DEPLOYMENT LINE GOT CAUGHT ON THE BMS, WHICH INTERFERED WITH THE DEVICE EXPANSION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23398322 ↗
• MalfunctionSep 3, 2025Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AUGUST 12, 2025, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR AN UNKNOWN ANATOMICAL LOCATION DURING TREATMENT OF AN UNKNOWN ETIOLOGY. AFTER THE VSX DEVICE WAS ADVANCED ACROSS THE LESION, THE PHYSICIAN ATTEMPTED TO DEPLOY. HOWEVER, AFTER DEPLOYMENT WAS INITIATED THE DEPLOYMENT LINE GOT HUNG UP AT THE TURN AROUND AND STARTED TO BOW STRING THE STENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956652 ↗
• MalfunctionJul 22, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR A PERIPHERAL ARTERY DISEASE (PAD) WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS ATTEMPTED TO BE USED IN THE SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED PRIOR TO INTRODUCING THE VIABAHN DEVICE, AN ELUVIA BOSTON SCIENTIFIC BARE-METAL STENT WAS INITIALLY IMPLANTED IN THE SFA. AFTER PRE-DILATING THE TARGET TREATMENT AREA, THE PHYSICIAN ADVANCED THE VIABAHN DEVICE OVER A TERUMO GLIDE WIRE ADVANTAGE .018" THROUGH A TERUMO DESTINATION 7FR INTRODUCER SHEATH TO SFA WITHOUT RESISTANCE. DEPLOYMENT OF THE VIABAHN DEVICE WAS INITIATED AND THE DEVICE ADVANCED; HOWEVER, THE PHYSICIAN SUSPECTS THE DEVICE MAY HAVE BECOME CAUGHT ON THE PREVIOUSLY IMPLANTED BARE-METAL STENT RESULTING IN A BREAKAGE OF THE DEPLOYMENT LINE. THE DEVICE WAS ONLY PARTIALLY DEPLOYED, AND IT REMAINS UNKNOWN HOW MANY INCHES WERE PULLED BEFORE THE DEPLOYMENT LINE BROKE. AT THIS TIME, THE PHYSICIAN SLOWLY WITHDREW THE PARTIALLY DEPLOYED VIABAHN DEVICE OUT OF THE PATIENT. REPORTEDLY, NOTHING WAS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A NEW VIABAHN DEVICE. THE DEPLOYMENT LINE WAS NOT PULLED TOO HARD

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571718 ↗
• MalfunctionMay 19, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR CALCIFICATION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WHERE A 6X15 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS USED. IT WAS REPORTED THE PHYSICIAN WAS ABLE TO REACH THE TARGET TREATMENT AREA GOING THROUGH AN INTRODUCER SHEATH (BRAND AND SIZE UNKNOWN) AND OVER A BOSTON SCIENTIFIC V-18¿ CONTROLWIRE¿ GUIDEWIRE, EVEN THOUGH THE TREATMENT AREA WAS NOT PREDILATED. THE PHYSICIAN INITIATED DEPLOYMENT BY TWISTING THE DEPLOYMENT KNOB AND PULLING THE DEPLOYMENT LINE. WHEN PULLING THE DEPLOYMENT LINE, A LOT OF RESISTANCE WAS FELT AND NOTICED BOWSTRINGING. NO FORCE WAS USED TO PULL THE DEPLOYMENT LINE, INSTEAD THE PHYSICIAN DECIDED TO WITHDRAW THE VIABAHN DEVICE THROUGH THE SHEATH. NO DEVICE EXPANSION WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING A NEW 6X15 VIABAHN DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22047216 ↗
• MalfunctionNov 5, 2024Difficult to Advance; Difficult to Advance

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 6 MM X 15 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS INTENDED FOR USE FOR AN UNKNOWN ETIOLOGY IN AN UNKNOWN LOCATION. IT WAS REPORTED THERE WAS RESISTANCE FELT WHEN THE VIABAHN® DEVICE WAS ADVANCED. THE VIABAHN® DEVICE WAS REMOVED FROM THE PATIENT AND IT APPEARED TO HAVE SEPARATION AT AN UNKNOWN PORTION OF THE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER VIABAHN® DEVICE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610477 ↗
• MalfunctionOct 25, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 6 MM X 15 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS INTENDED FOR USE IN AN UNKNOWN LOCATION FOR AN UNKNOWN ETIOLOGY. REPORTEDLY, WHEN THE PHYSICIAN PULLED THE DEPLOYMENT LINE OF THE VIABAHN® DEVICE IT WAS STUCK, AND THEREFORE LED TO FAILURE TO DEPLOY VIABAHN® DEVICE. THE PHYSICIAN THEN REMOVED THE VIABAHN® DEVICE WITHOUT DIFFICULTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER VIABAHN® DEVICE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20535304 ↗
• MalfunctionMay 17, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR CHRONIC TOTAL OCCLUSION (CTO) IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A 6 MM X 15 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). IT WAS REPORTED THE DELIVERY CATHETER WAS ADVANCED USING A 6F ANSEL INTRODUCER SHEATH OVER AN 0.014" COMMAND GUIDEWIRE TO THE PRE-DILATED TARGET LESION. REPORTEDLY, THE DEPLOYMENT KNOB WAS UNSCREWED AND THE DEPLOYMENT LINE WAS PULLED, BUT NOTHING HAPPENED (NOT STUCK, NO RESISTANCE FELT). THE DEPLOYMENT LINE CAME CLEAN OUT OF THE PATIENT AND THE ENDOPROSTHESIS FAILED TO DEPLOY. IT WAS REPORTED THE DELIVERY CATHETER AND ENDOPROSTHESIS WERE WITHDRAWN FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19344563 ↗
• InjuryFeb 7, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2024, A 6MM X 15CM A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS IMPLANTED FOR TREATMENT OF AN IN-STENT RESTENOSIS (UNKNOWN MANUFACTURER) LOCATED IN THE POPLITEAL ARTERY. APPROXIMATELY 10 HOURS POST-IMPLANT, THE PATIENT DEVELOPED LEG ISCHEMIA AND WAS EMERGENTLY TAKEN TO THE OR. AFTER THE DISTAL POPLITEAL ARTERY EXPOSURE AND CUT DOWN, THE ARTERY WAS OPENED AND THERE WAS NO FORWARD FLOW THROUGH THE VIABAHN DEVICE. AS SOON AS THE VIABAHN DEVICE WAS PULLED, THERE WAS SIGNIFICANT BLOOD INFLOW. THE VIABAHN DEVICE WAS EXPLANTED AND DISCARDED. THE ARTERIOTOMY WAS PATCHED WITH A BOVINE PATCH. BLOOD FLOW WAS RESTORED TO THE LOWER LEG WITH THAT TECHNIQUE.

  Patient problems: Ischemia

  MAUDE report 18660126 ↗
• InjuryNov 19, 2021Failure to Deliver; Detachment of Device or Device Component; Failure to Deliver; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A 6MM X 15CM GORE® VIABAHN® ENDOPROSTHESIS (VSX) DEVICE WAS INTENDED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY FOR TREATMENT OF STENOSIS. AFTER THE DEVICE WAS ADVANCED ACROSS THE LESION THE PHYSICIAN ATTEMPTED TO DEPLOY THE VSX DEVICE. HOWEVER, AFTER THE DEPLOYMENT LINE WAS REMOVED FROM THE PATIENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY CATHETER AND FELT RESISTANCE. AN ANGIOGRAPH SHOWED APPROXIMATELY 10 CENTIMETERS OF THE VSX DEVICE HAD FULL EXPANSION AND THE REMAINING DEVICE WAS STILL CONSTRAINED. THE PHYSICIAN ATTEMPTED TO CAPTURE THE DEVICE IN THE INTRODUCER SHEATH BUT WAS UNSUCCESSFUL. THE PHYSICIAN DECIDED TO PULL THE DELIVERY CATHETER AND VSX DEVICE TO THE ACCESS SITE, AND PERFORM A CUT DOWN TO REMOVE THE VSX DEVICE. AN ADDITIONAL VSX DEVICE WAS SUCCESSFULLY DELIVERED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 12847775 ↗
• MalfunctionJul 22, 2020Mechanical Problem; Mechanical Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020 THE PATIENT WAS BEING TREATED FOR OCCLUSIVE DISEASE IN THE PATIENTS SUPERFICIAL FEMORAL ARTERY USING GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE. IT WAS REPORTED THE DEPLOYMENT LINE WAS PULLED AND ONLY 25 PERCENT OF THE DEVICE EXPANDED. THE PHYSICIAN STATED THE SUSPECTED CAUSE OF THE DEVICE ONLY PARTIALLY DEPLOYING IS UNKNOWN. THE DEVICE WAS EXPLANTED FROM THE PATIENT. ANOTHER GORE® VIABAHN® ENDOPROSTHESIS WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10311832 ↗
• MalfunctionJan 2, 2020Difficult or Delayed Activation; Material Split, Cut or Torn; Difficult or Delayed Activation; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR OCCLUDED LEFT LEG SFA REPAIR. THE DOCTOR USED AN UP-AND-OVER APPROACH TO THE LESION. THE DEVICE WAS ADVANCED INTO PLACE. WHEN THE DEPLOYMENT LINE WAS PULLED, IT BROKE LEAVING THE GORE® VIABAHN® ENDOPROSTHESIS PARTIALLY DEPLOYED. THE FSA REPORTED THE DEPLOYMENT LINE, AT THE BREAK, APPEARED FRAYED. THE DOCTOR CUT THE CATHETER LONGITUDINALLY, MAKING LIKE A PEEL-AWAY SHEATH, LOCATED THE BROKEN DEPLOYMENT LINE AND COMPLETED THE DEVICE DEPLOYMENT BY PULLING THE REMAINING DEPLOYMENT LINE.

  Patient problems: Occlusion

  MAUDE report 9540964 ↗
• InjuryDec 20, 2019Material Separation; Material Separation

  ON (B)(6) 2019, THE PATIENT WAS BEING TREATED FOR AN UNKNOWN ETIOLOGY USING GORE® VIABAHN® ENDOPROSTHESES. IT WAS REPORTED THE DEPLOYMENT LINE BROKE NEAR THE PROXIMAL END OF THE STENT. THE STENT WAS REPORTEDLY APPROXIMATELY 75 PERCENT DEPLOYED WHEN THE DEPLOYMENT LINE BROKE. IT IS REPORTEDLY UNKNOWN WHAT CAUSED THE DEPLOYMENT TO BREAK. THE DEPLOYMENT LINE THAT REMAINED WAS REPORTEDLY TOO FAR DOWN FOR THE PHYSICIAN TO GRAB TO COMPLETE THE DEPLOYMENT. THE PHYSICIAN REPORTEDLY CUT THE HUB OF THE CATHETER. THE 6FR COOK ANSEL SHEATH WAS EXCHANGED FOR A 8FR COOK ANSEL SHEATH. AN ATTEMPT TO RETRIEVE THE ENTIRE DEVICE BY WITHDRAWING IT THROUGH THE SHEATH WAS UNSUCCESSFUL AS THE DEVICE WOULD NOT COME BACK INTO THE SHEATH. IT WAS REPORTED THE PHYSICIAN DECIDED TO SURGICALLY REMOVE THE DEVICE. A BYPASS PROCEDURE WAS ALSO PERFORMED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9504103 ↗
• MalfunctionAug 30, 2019Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE BY THE DOCTOR: THE PATIENT PRESENTED FOR A THORACIC DUCT CASE. THE GORE® VIABAHN® ENDOPROSTHESIS WAS TO BE PLACED IN THE PATIENT'S LYMPHATIC SYSTEM. THE GORE® VIABAHN® ENDOPROSTHESIS WAS PLACED IN THE TRUNK OF THE LYMPHATIC SYSTEM (IN THE ABDOMEN) AND ADVANCED TO THE SUBCLAVIAN VEIN. A SECOND WIRE WAS ADVANCED FROM THE ARM TO SNARE THE GORE® VIABAHN® ENDOPROSTHESIS IN THE LYMPHATIC SYSTEM. THE DOCTOR REPORTED THAT PATIENT ANATOMY WAS VERY TORTUOUS. WHEN THE DEVICE WAS POSITIONED, THE DEPLOYMENT LINE WAS PULLED. THE DEPLOYMENT HALTED AT THE DISTAL END OF THE GORE® VIABAHN® ENDOPROSTHESIS. THE DOCTOR WAS UNABLE TO COMPLETE DEPLOYMENT OF THE GORE® VIABAHN® ENDOPROSTHESIS SO PROCEEDED WITH STANDARD TREATMENT OF USING GLUE AND A COIL TO SEAL OFF THE DUCT. THE GORE® VIABAHN® ENDOPROSTHESIS REMAINS IN THE PATIENT. ACCORDING TO THE DOCTOR, THE PATIENT IS FINE.

  Patient problems: No Information

  MAUDE report 8952682 ↗
• InjuryJun 5, 2019Entrapment of Device; Detachment of Device or Device Component; Entrapment of Device; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT WAS TREATED DUE TO AN OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). AS REPORTED, THIS PATIENT HAD PREVIOUS SURGERIES AND ACCESS FROM THE FEMORAL ARTERY WAS NO LONGER AN OPTION. PEDAL APPROACH, WITH ACCESS FROM THE ANTERIOR TIBIAL ARTERY WAS MADE. AFTER ACCESS WAS OBTAINED, MULTIPLE BALLOON CATHETERS INCLUDING A 5X15 STERLING AND 3X200 MUSTANG WERE USED FOR VESSEL DILATION. A 6FR TERUMO SHEATH WAS THEN USED TO ADVANCE A 6X15 GORE® VIABAHN® ENDOPROSTHESIS OVER A PLATINUM PLUS WIRE. AS THE VIABAHN DEVICE WAS ADVANCED, IT BECAME STUCK WITHIN THE SHEATH. THE PHYSICIAN ATTEMPTED TO PULL THE DEVICE BACK OUT. AS THE VIABAHN DEVICE WAS MANIPULATED, THE WIRE INSIDE THE CATHETER WAS BROKEN. THE DEPLOYMENT LINE AT THE TRANSITION WAS SEVERED. THE PATIENT WAS TRANSFERRED FOR SURGICAL REPAIR. THE TIBIAL ARTERY WAS CUT DOWN TO ALLOW FOR THE CONSTRAINED VIABAHN DEVICE AND SHEATH TO BE REMOVED. AFTER THE ARTERY WAS REPAIRED, A SECOND ACCESS WAS MADE AT THE POPLITEAL ARTERY, LOCATED BEHIND THE KNEE. WIRE ACCESS WAS ACHIEVED, AND TWO VIABAHN DEVICES (6X25 AND 5X15) WERE DEPLOYED TO TREAT THE OCCLUSION IN THE SFA. POST PROCEDURE, THE PATIENT WAS REPORTED TO BE R

  Patient problems: Perforation of Vessels

  MAUDE report 8671202 ↗
• InjuryFeb 28, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2016, THIS PATIENT WAS IMPLANTED WITH A GORE® VIABAHN® ENDOPROSTHESIS TO TREAT AN IN-STENT RESTENOSIS IN THE LEFT SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2019, THE PATIENT PRESENTED WITH PAIN AT REST IN THE LOWER LEFT LEG. ON (B)(6) 2019, AN ANGIOGRAM OF THE LEFT LOWER LEG WAS PERFORMED. A REPEAT INTERVENTION WAS PERFORMED; HOWEVER, DETAILS WERE NOT PROVIDED.

  Patient problems: Pain

  MAUDE report 8377839 ↗