GORE VIABAHN Endoprosthesis with HeparinRecalls & reported problems across all models

We found 62 models of GORE VIABAHN Endoprosthesis with Heparin by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 285 adverse event reports in the FDA's MAUDE database, received between Aug 5, 2016 and Sep 28, 2026 — classified as 5 deaths, 85 injuries, 195 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (113 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 with Heparin problems

GORE VIABAHN Endoprosthesis with Heparin models

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

• GORE VIABAHN Endoprosthesis with Heparin VBJR061502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  18 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR081002A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  15 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR081502A

  Stent, Superficial Femoral Artery
  12 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR101002A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  12 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR051002A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  11 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR062502A

  Stent, Superficial Femoral Artery
  11 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR070502A

  Stent, Superficial Femoral Artery
  2 deaths10 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR061002A

  Stent, Superficial Femoral Artery
  10 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR071002A

  Stent, Superficial Femoral Artery
  9 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR060502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  9 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR100502A

  Stent, Superficial Femoral Artery
  9 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR080502A

  Stent, Superficial Femoral Artery
  8 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR051502A

  Stent, Superficial Femoral Artery
  8 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR090502A

  Stent, Superficial Femoral Artery
  8 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR050502A

  Stent, Superficial Femoral Artery
  7 reports
• GORE VIABAHN Endoprosthesis with Heparin VBH100502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  6 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR052502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  6 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR081002A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  5 reports
• GORE VIABAHN Endoprosthesis with Heparin VBH101002A

  Stent, Superficial Femoral Artery
  5 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR072502A

  Stent, Superficial Femoral Artery
  5 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR050702A

  Stent, Superficial Femoral Artery
  5 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR091002A

  Stent, Superficial Femoral Artery
  5 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR060502A

  Stent, Superficial Femoral Artery
  4 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR080501A

  Stent, Superficial Femoral Artery
  4 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR081502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 death4 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR080502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  4 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR070202A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  4 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR110502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  2 deaths4 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR130502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  4 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR131002A

  Stent, Superficial Femoral Artery
  4 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR071002A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  3 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR081501A

  Stent, Superficial Femoral Artery
  3 reports
• GORE VIABAHN Endoprosthesis with Heparin VBH130502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  3 reports
• GORE VIABAHN Endoprosthesis with Heparin VBH131002A

  Stent, Superficial Femoral Artery
  3 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR060202A

  Stent, Superficial Femoral Artery
  3 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR080702A

  Stent, Superficial Femoral Artery
  3 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR060702A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  3 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR101502A

  Stent, Superficial Femoral Artery
  3 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR062502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR070501A

  Stent, Superficial Femoral Artery
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR070502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR071001A

  Stent, Superficial Femoral Artery
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBH091502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBH101502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR082502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR070702A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJR070702A

  Stent, Superficial Femoral Artery
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR091502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBHR111002A

  Stent, Superficial Femoral Artery
  2 reports
• GORE VIABAHN Endoprosthesis with Heparin VBJ081002

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBHR060202A

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBHR061501A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBHR070201A

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBHR081001A

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBH090502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBH091002A

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBH110502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBH130202A

  Stent, Superficial Femoral Artery
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBJR071502A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBJR080202A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBJR080702A

  System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment
  1 report
• GORE VIABAHN Endoprosthesis with Heparin VBHR090702A

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

Recent GORE VIABAHN Endoprosthesis with Heparin adverse event reports

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

• MalfunctionSep 28, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925884 ↗
• MalfunctionSep 28, 2026Break; Activation Failure

  On (b)(6) 2026, the patient underwent treatment for stenosis using a GORE® VIABAHN® Endoprosthesis with HEPARIN Bioactive Surface (VIABAHN Device) that was intended to be placed in the right external iliac artery. It was reported the VIABAHN Device was advanced through a 7Fr (55 cm) COOK Flexor Ansel Guiding Sheath over a .018" (300 cm) ABBOTT Hi-Torque Steelcore Guidewire. Reportedly, the target treatment site was not predilated but the VIABAHN Device successfully reached the target treatment site. Upon attempted deployment, it was reported that the deployment line broke after an unknown length of the deployment line was pulled. It is unknown if there was any resistance felt. It was reported the endoprosthesis remained on the delivery catheter, fully constrained, and was removed in tandem with the delivery catheter through the sheath. Upon withdrawal, it was reported there was no endoprosthesis expansion noticed. Reportedly, there were no signs of delivery catheter breakage or detachment and no deployment line left inside the patient. It was reported there was no calcification and/or tortuous anatomy present. To complete the procedure, two new VIABAHN Devices were selected for use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917057 ↗
• MalfunctionSep 4, 2026Activation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50623722 ↗
• MalfunctionAug 14, 2026Activation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255607 ↗
• InjuryAug 4, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132769 ↗
• InjuryAug 4, 2026Insufficient Device Problem Information

  On (b)(6) 2026, the patient underwent treatment for an aneurysm within a pre-existing AV fistula using two GORE® VIABAHN® Endoprosthesis with HEPARIN Bioactive Surface (VIABAHN Devices) that were intended to be placed in the arm. It was reported the physician advanced the VIABAHN Devices through an 8F TERUMO Sheath over a .035" GLIDEWIRE Guidewire. It was reported both VIABAHN Devices prematurely dislodged from the delivery catheters after insertion. It is unknown if there was any resistance during advancement. It is also unknown if there was an attempt to deploy the VIABAHN Devices and it is unknown what condition the deployment lines were in. It was reported, both VIABAHN Devices were removed from the patient. To complete the procedure, it was reported the AV fistula needed surgical conversion for repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132714 ↗
• MalfunctionJul 29, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50064114 ↗
• MalfunctionJul 27, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037846 ↗
• MalfunctionJul 22, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906642 ↗
• InjuryJun 26, 2026Device Endoleak

  ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS IN CONJUNCTION WITH GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS DEVICES. THE PROCEDURE WAS INITIALLY PLANNED TO INCLUDE A UNILATERAL ILIAC BRANCH ENDOPROSTHESIS (IBE); HOWEVER, DUE TO TORTUOUS ILIAC ANATOMY, THIS APPROACH WAS DETERMINED TO BE NOT FEASIBLE. DURING VASCULAR ACCESS PREPARATION USING PROGLIDE, AND PRIOR TO INITIATION OF THE INTENDED ENDOVASCULAR REPAIR, A RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY OCCURRED. AS THE PATIENT¿S BLOOD PRESSURE BEGAN TO DECREASE, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS DEPLOYED ACROSS THE RIGHT EXTERNAL ILIAC ARTERY TO CONTROL BLEEDING. FOLLOWING HEMODYNAMIC STABILIZATION, THE TREATING TEAM PROCEEDED WITH A STANDARD EVAR, WHICH INCLUDED COIL EMBOLIZATION AND COVERAGE OF THE RIGHT HYPOGASTRIC ARTERY, GIVEN THE ANATOMICAL CONSTRAINTS AS WELL AS THE INCREASING PROCEDURAL COMPLEXITY AND DURATION. FINAL INTRAOPERATIVE IMAGING DEMONSTRATED SATISFACTORY RESULTS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY. POSTOPERATIVELY,

  Patient problems: Clinical Endoleak

  MAUDE report 25643414 ↗
• MalfunctionJun 4, 2026Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE CELIAC ARTERY DURING TREATMENT OF AN AORTIC ANEURYSM BEING TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). REPORTEDLY, AFTER THE DEVICE WAS ADVANCED OVER AN 0.035" ROSEN GUIDE WIRE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE VSX DEVICE. HOWEVER, AFTER DEPLOYMENT WAS INITIATED THE DEPLOYMENT LINE GOT HUNG UP AND THE PHYSICIAN WAS UNABLE TO COMPLETE DEPLOYMENT. WITH NO DEVICE EXPANSION, THE DELIVERY SYSTEM WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394709 ↗
• InjuryMay 21, 2026Entrapment of Device; Detachment of Device or Device Component; Device Damaged by Another Device; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, TREATMENT WAS REQUIRED IN THE PATIENT'S ILIAC ARTERY DUE TO AN ANEURYSM. AS REPORTED, A PREVIOUSLY IMPLANTED BARE METAL STENT WAS AT THE INTENDED TREATMENT SITE. THROUGH A SHEATH (UNSPECIFIED BRAND/SIZE) A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS ADVANCED OVER A LUNDERQUIST WIRE. IT WAS REPORTED THE PHYSICIAN DID NOT REALIZE THE WIRE WENT INTO INTERSTICES OF EXISTING BARE METAL STENT. THE VIABAHN® DEVICE DEPLOYMENT WAS STARTED AND THE FIRST LAYER UNRAVELED, THEN THE DEPLOYMENT LINE BROKE ON THE BARE METAL STENT. AS REPORTED, THE VIABAHN® STENT PARTIALLY EXPANDED; THE CATHETER WAS STUCK AND THE PHYSICIAN ATTEMPTED TO PULL BACK THE VIABAHN® CATHETER. THE DISTAL TIP BROKE OFF WHEN PULLING THE WIRE THAT WAS STUCK IN THE CATHETER. A CUTDOWN WAS PERFORMED TO REMOVE THE VIABAHN® DEVICE. IT WAS REPORTED THE PATIENT IS RECOVERING WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25250079 ↗
• MalfunctionMay 21, 2026Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A STENOSED STENT (UNKNOWN MANUFACTURE) WITHIN AN ARTERIOVENOUS (AV) FISTULA IN THE ARM USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). DURING THE PROCEDURE, THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING THE VIABAHN DEVICE TO THE TARGET TREATMENT AREA USING AN UNSPECIFIED SHEATH AND GUIDEWIRE. HOWEVER, UPON INITIATION OF DEPLOYMENT, THE PHYSICIAN NOTED THAT THE DEPLOYMENT LINE WOULD NOT PULL, RESULTING IN FAILURE TO DEPLOY. NO PORTION OF THE DEPLOYMENT LINE WAS SUCCESSFULLY PULLED, AND NO DEVICE EXPANSION WAS OBSERVED. DUE TO THE INABILITY TO DEPLOY THE VIABAHN DEVICE, THE PHYSICIAN WITHDREW THE VIABAHN DEVICE THROUGH THE SHEATH AND DISCARDED IT. A NEW VIABAHN DEVICE WAS SUBSEQUENTLY INTRODUCED AND DEPLOYED SUCCESSFULLY WITHOUT ISSUE, COMPLETING THE PROCEDURE. THE PHYSICIAN REPORTED THAT NO FORCE WAS USED TO PULL THE DEPLOYMENT LINE AND WAS UNSURE OF THE EXACT CAUSE OF THE ISSUE BUT SUSPECTED THAT THE DEPLOYMENT LINE MAY HAVE BECOME CAUGHT ON THE PREVIOUSLY IMPLANTED STENT WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25245070 ↗
• MalfunctionMay 21, 2026Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT TREATMENT FOR AN ANEURYSM WITH STENOSIS IN THE UPPER REGION OF AN EXISTING RIGHT FEMORAL-POPLITEAL BYPASS GRAFT (UNKNOWN MANUFACTURE) USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS REPORTED THE LESION WAS PRE-DILATED AND THE DELIVERY CATHETER ADVANCED TO THE TARGET TREATMENT SITE THROUGH A 7F TERUMO PINNACLE® DESTINATION® GUIDING SHEATH OVER A .035" TERUMO GLIDEWIRE ADVANTAGE GUIDEWIRE SUCCESSFULLY. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE ENDOPROSTHESIS, IT WAS REPORTED ONE-THIRD OF THE DEPLOYMENT LINE WAS PULLED, WHEN BOWSTRINGING WAS OBSERVED AND DEPLOYMENT WAS CEASED. THE PHYSICIAN THEN WITHDREW THE DELIVERY CATHETER THROUGH THE SHEATH WITH NO DELIVERY CATHETER DAMAGE OR ENDOPROSTHESIS DISTAL EXPANSION NOTICED. IT WAS REPORTED THE VIABAHN DEVICE WAS DEPLOYED SUCCESSFULLY ON THE BACK TABLE AND DISCARDED. TO COMPLETE THE PROCEDURE, IT WAS REPORTED A NEW DEVICE WAS SELECTED, ADVANCED AND DEPLOYED WITHOUT INCIDENT. IT WAS REPORTED THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25244628 ↗
• 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 ↗

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

• GORE EXCLUDER AAA Endoprosthesis81 models · 1,121 reports
• GORE DRYSEAL FLEX Introducer Sheath29 models · 1,009 reports
• 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