GORE VIABAHN EndoprosthesisRecalls & reported problems across all models

We found 26 models of GORE VIABAHN Endoprosthesis by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 58 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2018 and Sep 8, 2026 — classified as 1 death, 13 injuries, 44 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (29 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported GORE VIABAHN Endoprosthesis problems

GORE VIABAHN Endoprosthesis models

26 models, most reported first. Each model has its own page with its reports, recalls and device details.

• GORE VIABAHN Endoprosthesis VBCR081001A

  Stent, Superficial Femoral Artery
  10 reports
• GORE VIABAHN Endoprosthesis VBCR080501A

  Stent, Superficial Femoral Artery
  5 reports
• GORE VIABAHN Endoprosthesis VBCR101002A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  4 reports
• GORE VIABAHN Endoprosthesis VBCR111002A

  Stent, Superficial Femoral Artery
  4 reports
• GORE VIABAHN Endoprosthesis VBCR131002A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  4 reports
• GORE VIABAHN Endoprosthesis VBCR050502A

  Stent, Superficial Femoral Artery
  3 reports
• GORE VIABAHN Endoprosthesis VBCR081002A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  3 reports
• GORE VIABAHN Endoprosthesis VBC101002A

  Stent, Superficial Femoral Artery
  3 reports
• GORE VIABAHN Endoprosthesis VBCR100502A

  Stent, Superficial Femoral Artery
  3 reports
• GORE VIABAHN Endoprosthesis VBCR081501A

  Stent, Superficial Femoral Artery
  2 reports
• GORE VIABAHN Endoprosthesis VBCR130502A

  Stent, Superficial Femoral Artery
  2 reports
• GORE VIABAHN Endoprosthesis VBC060502

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis VBC070502

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis VBC071002

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis VBC080502

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis VBC081002

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis VBC101502

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis VBC130502

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis VBCR060202A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 death1 report
• GORE VIABAHN Endoprosthesis VBCR060502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis VBCR070202A

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis VBCR070501A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis VBCR070502A

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis VBCR071501A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis VBCR071502A

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis VBCR081502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report

Recent GORE VIABAHN Endoprosthesis adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2026Activation Failure; Physical Resistance/Sticking

  On (b)(6) 2026, a patient underwent an endovascular procedure to treat a stenotic occlusion at the venous outflow anastomosis of an arteriovenous access graft (brand unknown) using a 10 mm x 10 cm GORE® VIABAHN® Endoprosthesis.It was reported that the delivery catheter advanced through an 8 Fr TERUMO Introducer Sheath over a 0.035-inch TERUMO GLIDWIRE Guidewire to the target treatment site.During deployment of the endoprosthesis, the deployment line was pulled and met resistance at the distal turnaround point of the endoprosthesis. The decision was made to stop deployment. The delivery system was removed from the patient successfully with the catheter intact. It was reported that there was no distal expansion of the endoprosthesis. An attempt was made to deploy the endoprosthesis on the back table, However, this was unsuccessful. To complete the procedure, another GORE® VIABAHN® Endoprosthesis was used with an Amplatz Super Stiff Guidewire.It was reported that there was no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669438 ↗
• MalfunctionApr 8, 2026Difficult or Delayed Positioning; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT PRESENTED FOR TREATMENT IN THE LEFT AXILLARY VEIN DUE TO CHRONIC REOCCURRING STENOSIS. DURING THE PROCEDURE, THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) WAS ADVANCED OVER AN 0.035 ANGIODYNAMICS BENTSON GUIDEWIRE. AS REPORTED, THE VIABAHN® DEVICE WAS ADVANCED WITHOUT THE AID OF A SHEATH. DEPLOYMENT WAS STARTED WHEN THE VIABAHN® STENT STARTED MOVING DISTALLY FROM THE TREATMENT AREA. THE VIABAHN® STENT WAS REPOSITIONED, BUT THE VIABAHN® LINE WAS STUCK AND DEPLOYMENT COULD NOT BE CONTINUED. THE CONSTRAINED VIABAHN® DEVICE WAS REMOVED FROM THE PATIENT WITH NO ISSUES AND NO HARM TO PATIENT. AS REPORTED, THE PHYSICIAN SAID THE ISSUE LIKELY OCCURRED BECAUSE HE REPOSITIONED WHILE DEPLOYING THE STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24824008 ↗
• MalfunctionApr 3, 2026Entrapment of Device; Device-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: A PATIENT PRESENTED FOR TREATMENT OF AN IN-STENT EDGE STENOSIS IN THE PATIENT'S ARM. AS REPORTED, THERE WAS A PRE-EXISTING GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE). IMPLANT DATE OF PRE-EXISTING VIABAHN® STENT IS UNKNOWN. DURING AN A-V CIRCUIT INTERVENTION, THE TARGET LESION WAS NOT PRE-DILATED. A 7MM X 5CM VIABAHN® DEVICE WAS DEPLOYED . ON IMAGING, THE EXPANDED VIABAHN® STENT END APPEARED TO BE BUNCHED. THE VIABAHN® STENT WAS POST-DILATED, WHICH FURTHER IMPROVED THE BLOOD FLOW. AS REPORTED, A SMALL SECTION OF THE STENOTIC LESION WAS NOT COVERED, AND THE COMPRESSED AREA WAS STILL PRESENT AT THE END OF THE PROCEDURE. THE PHYSICIAN CHOSE A 'WAIT AND SEE' APPROACH. THE PATIENT TOLERATED THE PROCEDURE AND WAS REPORTED TO BE RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780103 ↗
• MalfunctionFeb 23, 2026Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2026, A PATIENT UNDERWENT A REVISION OF A NATIVE FISTULA PROCEDURE FOR VASCULAR ACCESS IN THE UPPER RIGHT ARM, DURING WHICH A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS USED. DURING THE PROCEDURE, THE DELIVERY CATHETER WAS ADVANCED WITHOUT RESISTANCE THROUGH AN MERIT 8F SHEATH OVER A COOK BENTSON GUIDEWIRE TO THE TARGET TREATMENT SITE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE; HOWEVER, THE DEVICE DID NOT DEPLOY AS INTENDED. THE REPORTER STATED THAT WHEN PULLING ON THE DEPLOYMENT LINE, RESISTANCE WAS FELT. THE PHYSICIAN PULLED HARDER AND EXPERIENCED MORE RESISTANCE THAN DESIRED AND SUBSEQUENTLY DECIDED TO WITHDRAW THE DELIVERY CATHETER. A NEW VIABAHN DEVICE OF THE SAME SIZE WAS USED, AND THE REPLACEMENT DEVICE DEPLOYED AS INTENDED. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415700 ↗
• MalfunctionJan 16, 2026Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR TREATMENT FOR A LEFT UPPER ARM AV FISTULA ACCESS IN THE CEPHALIC ARCH. IT IS NOT SPECIFIED IF THERE WAS A PRE-EXISTING DEVICE. AS REPORTED, THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) REACHED THE INTENDED TREATMENT SITE AND DEPLOYMENT WAS STARTED. HOWEVER, THE VIABAHN® DEVICE DID NOT EXPAND COMPLETELY AT THE TREATMENT AREA (CEPHALIC ARCH). THE VIABAHN® DEVICE COULD NOT BE RELEASED FROM THE CATHETER UNTIL IT WAS PULLED BACK MORE PERIPHERALLY INTO THE CEPHALIC VEIN. IT WAS REPORTED THE CEPHALIC VEIN AREA WAS CONSIDERED TOO SMALL FOR THE VIABAHN® DEVICE. THE PHYSICIAN CHOSE A LARGER STENT (12X80 PROTEGE) TO TRAP THE VIABAHN® DEVICE TO PATIENT'S VESSEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 24096741 ↗
• MalfunctionDec 5, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A BASILIC VEIN OUTFLOW STENOSIS IN A DIALYSIS PATIENT, AN 8FR PINNACLE SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) OVER AN .035 STIFF GLIDE WIRE. AS REPORTED, THERE WERE NO PRE-EXISTING DEVICES IN THE TREATMENT AREA. IT WAS REPORTED THE VIABAHN® DEVICE REACHED THE INTENDED TREATMENT AREA AND DEPLOYMENT WAS STARTED, BUT THE DEPLOYMENT LINE WOULD NOT RELEASE. THE PHYSICIAN TRIED SEVERAL MANEUVERS WITHOUT SUCCESS. THE CONSTRAINED VIABAHN® DEVICE WAS REMOVED. A NEW VIABAHN® DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733687 ↗
• InjuryDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DIALYSIS ACCESS GRAFT REVISION (NON-GORE GRAFT). REPORTEDLY AFTER THE DEVICE WAS SUCCESSFULLY DELIVERED, THE PHYSICIAN FELT RESISTANCE DURING THE REMOVAL OF THE DELIVERY CATHETER. AFTER THE REMOVAL OF THE DELIVERY CATHETER, IT WAS OBSERVED TO BE MISSING THE DISTAL PORTION OF THE DELIVERY CATHETER. THE PATIENT WAS SENT HOME AND ADVISED TO GO TO THE EMERGENCY ROOM (ER) THE NEXT DAY. THE PATIENT WENT TO THE ER AND HAD THE CATHETER PIECE REMOVED WITH A SNARE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23706915 ↗
• MalfunctionNov 3, 2025Activation Failure; Activation Failure

  ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT AN UNKNOWN ETIOLOGY WHERE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED IN AN UNKNOWN ANATOMICAL LOCATION. THE PHYSICIAN REACHED THE TARGET TREATMENT AREA AND INITIATED DEPLOYMENT BY PULLING THE DEPLOYMENT LINE. THE DEPLOYMENT LINE WAS ABLE TO UNZIP FROM THE VIABAHN DEVICE, HOWEVER, THE VIABAHN ENDOPROSTHESIS WAS UNABLE TO EXPAND AND REMAINED ON THE DELIVERY CATHETER. THE VIABAHN DEVICE WAS REMOVED FROM THE PATIENT WITH NO ISSUES AND THE PROCEDURE WAS COMPLETED USING A NEW VIABAHN DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452127 ↗
• InjuryOct 20, 2025Difficult or Delayed Activation; Separation Problem; Difficult or Delayed Activation; Separation Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN ETIOLOGY WHERE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS INTENDED TO BE PLACED IN THE SUBCLAVIAN ARTERY. THE PHYSICIAN USED A 10FR TERUMO INTRODUCER SHEATH AND A 0.035" COOK MEDICAL ROADRUNNER® PC HYDROPHILIC WIRE GUIDE TO ADVANCE THE VIABAHN DEVICE TO THE TARGET TREATMENT AREA WITH NO RESISTANCE. DEPLOYMENT OF THE DEVICE WAS INITIATED; HOWEVER, THE VIABAHN DEVICE FAILED TO DEPLOY. IT IS UNCLEAR HOW MUCH OF THE DEPLOYMENT LINE WAS PULLED PRIOR TO THE ATTEMPT TO WITHDRAW THE CONSTRAINED DEVICE. DURING THE WITHDRAWAL OF THE VIABAHN DEVICE IN TANDEM WITH THE SHEATH, RESISTANCE WAS ENCOUNTERED. SUBSEQUENTLY, THE DEVICE UNINTENTIONALLY DISLODGED WITHIN THE PATIENT¿S UPPER ARM. A SURGICAL CUTDOWN WAS REQUIRED TO RETRIEVE THE DEPLOYED VIABAHN DEVICE. NO PRIOR ATTEMPTS WERE MADE TO RETRIEVE THE DISLODGED ENDOPROSTHESIS THROUGH NON-SURGICAL MEANS. THE PROCEDURE WAS COMPLETED BY SUTURING THE PATIENT¿S ARTERY. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED. THE PHYSICIAN NOTED THAT THERE WERE NO INDICATIONS OF TORTUOUS ANATOMY OR CALCIFICATION, AND THE ROOT CAUSE OF THE DEPLOYMENT ISSUE REMAINS UNDETERMINED.

  Patient problems: Failure of Implant

  MAUDE report 23337702 ↗
• MalfunctionOct 15, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR AN ARTERIOVENOUS (AV) FISTULA IN THE UPPER ARM USING A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE). IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE VIABAHN DEVICE OVER A 0.035" GLIDEWIRE THROUGH A CORDIS 8FR INTRODUCER SHEATH. THE PHYSICIAN ENCOUNTERED RESISTANCE DURING ADVANCEMENT. WHILE ATTEMPTING TO DEPLOY THE DEVICE, THE PHYSICIAN WAS ABLE TO PULL THE DEPLOYMENT LINE (SOME STRING WAS PULLED), BUT FULL DEPLOYMENT WAS UNSUCCESSFUL. THE DEVICE WAS SUBSEQUENTLY WITHDRAWN THROUGH THE SHEATH, AND NO COMPONENTS REMAINED INSIDE THE PATIENT. IT WAS REPORTED THAT THE TARGET TREATMENT AREA HAD BEEN REACHED PRIOR TO THE DEPLOYMENT ATTEMPT, AND SOME DEVICE EXPANSION WAS OBSERVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PHYSICIAN WAS UNCERTAIN ABOUT THE CAUSE OF THE DEPLOYMENT ISSUE, AND THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23306012 ↗
• MalfunctionSep 3, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6), 2025 A PATIENT UNDERWENT A PROCEDURE FOR STENOSIS IN A PREVIOUSLY IMPLANTED UPPER EXTREMITY GRAFT (BRAND UNKNOWN) USING AN 8 MM × 10 CM GORE® VIABAHN® ENDOPROSTHESIS. IT WAS REPORTED VASCULAR ACCESS WAS ESTABLISHED USING AN UNKNOWN SIZE / BRAND INTRODUCER SHEATH OVER A AN UNKNOW SIZE / BRAND GUIDE WIRE. IT IS UNKNOWN WHETHER THE TARGET LESION UNDERWENT PRE-DILATION PRIOR TO ATTEMPTED DEVICE DELIVERY. REPORTEDLY, DURING DEPLOYMENT THE DEPLOYMENT LINE WAS PULLED AND THE ENDOPROSTHESIS STARTED BUCKLING. THE DELIVERY SYSTEM CATHETER WAS WITHDRAWN FROM THE PATIENT INTACT AND WITHOUT DISTAL EXPANSION OF THE ENDOPROSTHESIS. THE DEPLOYMENT LINE APPEARED TO BE WRAPPED AROUND THE END OF THE STENT. REPORTEDLY, THE DEPLOYMENT LINE WAS NOT BROKEN. AN ATTEMPT TO ACTUATE THE DEPLOYMENT MECHANISM OUTSIDE THE PATIENT WAS MADE. THE ENDOPROSTHESIS DEPLOYED ON THE BACK TABLE WITH EXTRA FORCE. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956616 ↗
• MalfunctionSep 2, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: A PATIENT PRESENTED FOR TREATMENT OF A DIALYSIS ACCESS OUTFLOW STENOSIS. AS REPORTED, THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) WAS PLACED AT THE TREATMENT ZONE AND DEPLOYMENT WAS STARTED. HOWEVER, THE DEPLOYMENT LINE BECAME STUCK AFTER IT UNRAVELED ABOUT A FOURTH OF THE WAY ON THE FIRST LAYER. AS THE SECOND LAYER WAS NOT UNRAVELED, THE VIABAHN® DEVICE REMAINED CONSTRAINED AND WAS REMOVED WITH NO ISSUES AND NO IMPACT TO THE PATIENT. A NEW VIABAHN® DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22940300 ↗
• MalfunctionAug 26, 2025Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDER WENT ENDOVASCULAR TREATMENT OF A VENOUS ANASTOMOSIS OF AN AV GRAFT WITH A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE). HOWEVER, THE DEPLOYMENT LINE GOT STUCK WHEN THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THIS VSX DEVICE IN THE VENOUS ANASTOMOSIS OF AN AV GRAFT. HE TRIED ONE MORE TIME BUT FELT IT WAS SAFER TO REMOVE THIS DEVICE. THE PHYSICIAN SUCCESSFULLY DEPLOYED A NEW VSX DEVICE TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22899663 ↗
• MalfunctionJul 24, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR STENOSIS IN THE CEPHALIC ARCH/SUBCLAVIAN VEIN WHERE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS INTENDED TO BE USED. ACCESS TO THE TARGET SITE WAS SUCCESSFULLY ACHIEVED VIA A 10FR BOSTON SCIENTIFIC SUPER SHEATH AND A 180 CM BOSTON SCIENTIFIC BENTSON GUIDEWIRE WITHOUT ANY RESISTANCE. UPON DELIVERY OF THE VIABAHN DEVICE, DEPLOYMENT WAS INITIATED BY PULLING ON THE DEPLOYMENT LINE. DURING THIS PROCESS, THE PHYSICIAN ENCOUNTERED RESISTANCE. THE ENDOPROSTHESIS PARTIALLY EXPANDED AT THE DISTAL END; HOWEVER, EXPANSION CEASED MIDWAY AND COULD NOT BE COMPLETED. MULTIPLE ATTEMPTS WERE MADE TO FULLY DEPLOY THE DEVICE, BUT RESISTANCE ALONG THE DEPLOYMENT LINE PERSISTED. ULTIMATELY, THE DEVICE WAS RETRIEVED IN TANDEM WITH THE SHEATH AND WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE PROCEDURE WAS THEN COMPLETED USING BALLOON ANGIOPLASTY. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT. NO TORTUOUS ANATOMY NOR CALCIFICATION WAS PRESENT IN THE TARGET TREATMENT AREA. HOWEVER, A PREVIOUSLY PLACED STENT (MANUFACTURER UNKNOWN) WAS PRESENT AT THE TREATMENT SITE. THE PHYSICIAN IS UNSURE WHAT CAUSED THE DEPLOYMENT LINE TO BECOME STUCK SINCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592942 ↗
• MalfunctionJul 24, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR INTERVENTION TO ADDRESS GENERALIZED ARTERIAL DISEASE INVOLVING THE LEFT EXTERNAL ILIAC ARTERY. A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS SUCCESSFULLY DEPLOYED AT THE INTENDED TREATMENT SITE. THE DEVICE WAS ADVANCED AND IMPLANTED WITHOUT RESISTANCE USING AN 8FR COOK MEDICAL INTRODUCER SHEATH AND A TERUMO 0.035" GLIDEWIRE ADVANTAGE® GUIDEWIRE. DURING THE ATTEMPTED WITHDRAWAL OF THE VIABAHN DELIVERY SYSTEM THROUGH THE SHEATH, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN APPLIED ADDITIONAL FORCE, AND UPON REMOVAL, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM HAD DETACHED AND REMAINED WITHIN THE PATIENT. THE DETACHED COMPONENT WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. THE PATIENT¿S VASCULAR ANATOMY DEMONSTRATED TYPICAL CALCIFICATION AND TORTUOSITY. THERE WERE NO REPORTED ADVERSE EFFECTS OR CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589500 ↗

Other W. L. Gore & Associates, Inc. products

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• GORE EXCLUDER AAA Endoprosthesis with C3 Delivery51 models · 988 reports
• GORE DUALMESH PLUS BIOMATERIAL12 models · 734 reports
• GORE VIABAHN VBX Balloon Expandable Endo111 models · 557 reports · 1 recall
• GORE DUALMESH Biomaterial13 models · 485 reports
• GORE EXCLUDER Iliac Branch Endoprosthesis6 models · 469 reports
• GORE EXCLUDER Conf AAA Endo - Trunk-Ipsilateral10 models · 427 reports