GORE-TEX Vascular GraftRecalls & reported problems across all models

We found 17 models of GORE-TEX Vascular Graft by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 40 adverse event reports in the FDA's MAUDE database, received between Jan 14, 2019 and Jan 27, 2025 — classified as 2 deaths, 38 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (10 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-TEX Vascular Graft problems

GORE-TEX Vascular Graft models

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

• GORE-TEX Vascular Graft SRRT06060080L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  9 reports
• GORE-TEX Vascular Graft RRT06060080L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  6 reports
• GORE-TEX Vascular Graft RRT07070080L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  4 reports
• GORE-TEX Vascular Graft RRT08070080L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  3 reports
• GORE-TEX Vascular Graft V06070L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  3 reports
• GORE-TEX Vascular Graft SRD06005045L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• GORE-TEX Vascular Graft SRRT06030040L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 death2 reports
• GORE-TEX Vascular Graft ST0701

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• GORE-TEX Vascular Graft RT05005015L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Vascular Graft SRRT06070080L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 death1 report
• GORE-TEX Vascular Graft ST0507

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Vascular Graft ST0601

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Vascular Graft ST0608

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Vascular Graft ST0804

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Vascular Graft ST0807

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Vascular Graft ST35010A

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Vascular Graft VT07070L

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report

Recent GORE-TEX Vascular Graft adverse event reports

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

• DeathJan 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY: UNEXPECTED DEATH, POSSIBLY RELATED TO AV (ARTERIOVENOUS) GRAFT HEMORRHAGE AT ACCESS SITE. PATIENT WAS FOUND UNRESPONSIVE IN ROOM, HEMORRHAGE EVIDENT. DNR (DO-NOT-RESUSCITATE ORDER). 2200-A:-OTHER USED TO CAPTURE HEMORRHAGE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21246375 ↗
• InjuryJul 10, 2024Complete Blockage; Device Stenosis; Complete Blockage; Device Stenosis

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE FROM THIRD PARTY: ON (B)(6) 2024, THE PATIENT PRESENTED WITH A COMPROMISED RIGHT LOWER LIMB DUE TO SEVERE CHRONIC ISCHEMIA. ON THE SAME DAY, IN AN ATTEMPT TO SAVE THE LIMB, A GORE-TEX® STRETCH VASCULAR GRAFT (GRAFT) WAS IMPLANTED AS A PROSTHETIC RIGHT FEMORO-TIBIAL BYPASS TO TREAT ISCHEMIA. ON THE SAME DAY, THE PATIENT UNDERWENT RIGHT TRANSFEMORAL AMPUTATION BECAUSE OF ACUTE ISCHEMIA. IT WAS REPORTED THAT A SEGMENT OF THE GRAFT WAS EXPLANTED FROM THE AMPUTATED LOWER LIMB. REPORTEDLY THIS GRAFT SEGMENT APPEARED TO BE THROMBOSED. IT WAS MENTIONED BY THE SURGEON THAT GRAFT THROMBOSIS WAS MOST PROBABLY CAUSED BY INSUFFICIENT BLOOD FLOW PER MINUTE THROUGH THE GRAFT DUE TO GENERAL CRITICAL ISCHEMIA. BECAUSE OF GENERAL CRITICAL ISCHEMIA AND BECAUSE THE LOWER LIMB WAS ALREADY COMPROMISED, THEY DECIDED AGAINST A FURTHER MINIMAL-INVASIVE PROCEDURE TO RE-ESTABLISH BLOOD FLOW THROUGH THE GRAFT AND INSTEAD AMPUTATED THE LOWER LIMB.

  Patient problems: Ischemia; Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 19712398 ↗
• InjuryJun 17, 2024Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR AN ACUTE ISCHEMIA IN THE LEFT LOWER LIMB WITH A GORE-TEX® STRETCH VASCULAR GRAFT - THIN-WALLED REMOVABLE RINGED. THE PROSTHESIS WAS IMPLANTED ON (B)(6) 2023, AS A BYPASS BETWEEN THE SUPRA-ARTICULAR POPLITEAL ARTERY AND THE SUB-ARTICULAR POPLITEAL ARTERY OF THE LEFT LOWER LIMB IN ORDER TO TREAT AN ACUTE ISCHEMIA WITH SENSITIVOMOTOR DISORDERS. AN ABSCESS WAS NOTED ON THE POPLITEAL FOSSA. ON (B)(6) 2024, AFTER APPROXIMATELY 1 MONTH, THE PROSTHESIS WAS EXPLANTED DUE TO A PSEUDOMONAS INFECTION. DURING THE SAME PROCEDURE, A FEMOROPOPLITEAL BYPASS USING AN ARTERIAL ALLOGRAFT WAS IMPLANTED. THE PATIENT WAS AUTHORISED TO RETURN HOME ON (B)(6) 2024.

  Patient problems: Bacterial Infection

  MAUDE report 19545255 ↗
• InjuryApr 30, 2024Partial Blockage; Partial Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON MAY 9, 2022 A 6MM GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED AS PART OF A BYPASS BETWEEN THE LEFT SUBCLAVIAN ARTERY AND THE LEFT COMMON CAROTID ARTERY. THE PATIENT WAS FURTHER TREATED WITH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESES (TBE) IN ZONE 1. ON (B)(6) 2022 DURING THE PATIENT'S ONE MONTH FOLLOW UP, IT WAS NOTICED THAT THE GRAFT HAD OCCLUDED. A BILATERAL UPPER EXTREMITY AND LOWER EXTREMITY ARTERIAL DOPPLER WERE PERFORMED. THE LEFT UPPER EXTREMITY ARTERIAL DOPPLER SHOWS LEFT SUBCLAVIAN ARTERIAL DISEASE WITH MODERATE FLOW REDUCTION TO THE WRIST. THE PHYSICIAN EVALUATED THE PATIENT WITH NO INTERVENTION NECESSARY. IT WAS NOTICED THAT THE PATIENT'S DECREASED FLOW IN THE LEFT SUBCLAVIAN IS CONSISTENT WITH THE KNOWN OCCLUSION OF THE LEFT CAROTID STENT THAT WAS IDENTIFIED OUTPATIENT.

  Patient problems: Obstruction/Occlusion; Reduced Blood Flow

  MAUDE report 19217875 ↗
• InjuryMar 28, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, A GORE-TEX® VASCULAR GRAFT GRAFT (THIN-WALLED, REMOVABLE RINGS) WAS IMPLANTED IN A BYPASS PROCEDURE, FROM THE AXILLARY ARTERY TO THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). DURING A FOLLOW-UP ON (B)(6) 2023, THE IMAGING SCAN SHOWED THE VASCULAR GRAFT APPEARANCE WAS NORMAL. AS REPORTED, THE PHYSICIAN WAS NOT AWARE OF ANY TRAUMA THE PATIENT EXPERIENCED. THE PHYSICIAN DID SPECULATE IT WAS POSSIBLE THE ILIAC CREST WAS RUBBING ON THE VASCULAR GRAFT, LEADING TO SOME DETERIORATION. IT WAS ALSO POSSIBLE THE PATIENT CHANGED SLEEPING POSITIONS WHICH CAUSED THE VASCULAR GRAFT TO DEGRADE. DURING A FOLLOW-UP ON (B)(6) 2024, IMAGING SHOWED THE 6MM GORE-TEX® VASCULAR GRAFT APPEARED TO BE DISRUPTED IN THE DISTAL TO MID-SECTION. AS REPORTED, THE PATIENT WAS ASYMPTOMATIC. RE-INTERVENTION WAS PLANNED FOR A LATER DATE. ON (B)(6) 2024, THE RE-INTERVENTION WAS PERFORMED. AN 8X25 GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED TO COVER THE DISRUPTED SECTION OF THE GORE-TEX® VASCULAR GRAFT. PATIENT WAS RECOVERING WELL FOLLOWING THE SUCCESSFUL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19000310 ↗
• InjuryOct 30, 2023Microbial Contamination of Device; Contamination /Decontamination Problem; Microbial Contamination of Device; Contamination /Decontamination Problem

  THE FOLLOWING WAS REPORTED TO GORE FROM THE VIDOC STUDY DATABASE: ON (B)(6) 2015, THIS 79-YEAR-OLD PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR PERIPHERAL ARTERY DISEASE IN THE RIGHT LOWER EXTREMITY. THE PATIENT WAS TREATED WITH A GORE-TEX® STRETCH VASCULAR GRAFT. NO ADVERSE EVENTS WERE REPORTED DURING THE PROCEDURE. THE DEVICE WAS IMPLANTED AND RETAINED. ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED WITH RIGHT LOWER LIMB ISCHEMIA WHICH REQUIRED INTERVENTION. MEDICAL/SURGICAL INTERVENTION, AT THAT TIME, IS UNKNOWN (B)(4). SEVERAL WEEKS LATER, ON (B)(6) 2016, THE PATIENT WAS HOSPITALIZED WITH ¿PROSTHETIC (DISTAL FLOW) SEPSIS (WITHIN THE GORE DEVICE) WHICH REQUIRED INTERVENTION. ON (B)(6) 2016, EVACUATION OF HEMATOMA WAS PERFORMED, NOT LOCATED WITHIN THE STUDY DEVICE, BUT INTERVENTION INCLUDED IN THE FORM OF EXPLANTATION OCCURRED. THE PATIENT DIED ON (B)(6) 2017 (B)(4).

  Patient problems: Hematoma; Insufficient Information; Sepsis

  MAUDE report 18030370 ↗
• InjurySep 5, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO GORE THAT THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM FOR ISCHEMIA EXCEEDED AT THE LEVEL OF THE LEFT LOWER LIMB WITH NECROSIS GOING UP ABOVE THE ANKLE. A LEFT TRANS-FEMORAL AMPUTATION WAS PERFORMED ON (B)(6) 2023. ON (B)(6) 2023, A RIGHT ILIO-FEMORO-POPLITEAL-LEG THROMBECTOMY WAS PERFORMED ASSOCIATED WITH A GORE PROSTHETIC SUB-ARTICULAR FEMORO-POPLITEAL BYPASS (GORE-TEX® STRETCH VASCULAR GRAFT THIN WALL REMOVABLE RINGS) OF THE RIGHT LOWER LIMB TO TREAT THE CRITICAL ISCHEMIA. IT WAS STATED THAT ON (B)(6) 2023, DUE TO A THROMBOSIS, A NEW SURGICAL TREATMENT WAS PERFORMED FOLLOWING OBLITERATION OF THE GORE BYPASS AND THE ILIAC AXIS UPSTREAM. ABLATION OF THE THROMBOSED BYPASS WAS PERFORMED ASSOCIATED WITH REPAIR OF THE FEMORAL TRIPOD WITH PATCH, THROMBECTOMY AND STENTING ANGIOPLASTY OF THE RIGHT EXTERNAL ILIAC ARTERY. A FEMORO-FIBULAR BYPASS WITH THE GREAT SAPHENOUS VEIN IN SITU WAS PERFORMED AND A VASCULAR PERICARDIUM PATCH WAS IMPLANTED ON BOTH BRANCHES OF THE DEEP AND CIRCUMFLEX FEMORAL ARTERIES. EXTERNAL ILIAC ARTERY ANGIOPLASTY WAS ALSO PERFORMED AND THE POST-OPERATIVE FOLLOW-UP WAS SIMPLE WITHOUT AGGRAVATION. THE PATIENT RETURNED HOME ON (B)(6) 2023.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17682047 ↗
• InjurySep 5, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED URGENTLY TO THE VASCULAR SURGERY DEPARTMENT BY HIS ANGIOLOGIST ON (B)(6) 2023, WITH WORSENING PAIN IN THE RIGHT LOWER LIMB WITH NO TROPHIC DISORDERS OR SENSORY-MOTOR DEFICITS. ON (B)(6) 2023, A THROMBO-EMBOLECTOMY OF THE SUPERFICIAL FEMORAL ARTERY AND THE RIGHT POPLITEAL ARTERY WAS PERFORMED. ON (B)(6) 2023, THE PATIENT PRESENTED WITH ACUTE ISCHAEMIA AND MOTOR DEFICIT OF THE RIGHT LOWER LIMB AND UNDERWENT A PROSTHETIC SUB-ARTICULAR FEMORO-POPLITEAL BYPASS WITH A GORE-TEX® STRETCH VASCULAR GRAFT THIN WALLED REMOVABLE RINGS. ON (B)(6) 2023, A FOLLOW-UP DOPPLER ULTRASOUND REVEALED OBSTRUCTION OF THE BYPASS AT ITS ORIGIN. THROMBECTOMY OF THE FEMORO-POPLITEAL BYPASS COMBINED WITH ANGIOPLASTY OF THE RIGHT ANTERIOR TIBIAL ARTERY WAS PERFORMED. THE POST-OPERATIVE FOLLOW-UP WAS UNFAVOURABLE, WITH THE LEG REMAINING ISCHAEMIC AND DEFICIENT. AMPUTATION WAS THEREFORE DECIDED ON (B)(6) 2023. AFTER AMPUTATION, THE PATIENT PRESENTED WITH AN EPISODE OF RECTAL BLEEDING AND ACUTE RENAL FAILURE. HE, WAS THEN TRANSFERRED TO A RE-EDUCATION AND FUNCTIONAL REHABILITATION ESTABLISHMENT AND THEN TO AN ESTABLISHMENT FOR THE ELDERLY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 17681873 ↗
• InjuryAug 30, 2023Microbial Contamination of Device; Microbial Contamination of Device

  A STUDY ALERT FROM THE PVG 21-01 CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2016, THE PATIENT UNDERWENT TREATMENT FOR AN OCCLUSIVE PERIPHERAL ARTERY DISEASE IN WHICH A GORE-TEX® STRETCH VASCULAR GRAFT WAS USED AS A BYPASS FOR A FEMORO-PERONEAL PROCEDURE. THE PATIENT WAS DISCHARGED ON (B)(6) 2016. REPORTEDLY, THE WHOLE PROCEDURE WAS UNEVENTFUL, VASCULAR ACCESS WAS SUCCESSFULLY GAINED, DEVICE DEPLOYED AS INTENDED, CATHETER WAS SUCCESSFULLY REMOVED AND THE PATENCY OF THE DEVICES WERE CONFIRMED AT THE END OF THE PROCEDURE. THE PATIENT RECEIVED AN ADDITIONAL ANTIPLATELET MEDICATION DURING THE PROCEDURE. REPORTEDLY ON (B)(6) 2018 A GRAFT INFECTION WAS DISCOVERED, THIS WAS A RECORDED AS DEVICE-RELATED. AN UNSPECIFIED REINTERVENTION WAS ADMINISTERED AND THE PATIENT REQUIRED WITHOUT A SEQUELAE.

  Patient problems: Bacterial Infection; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17649094 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED TO GORE THAT, ON (B)(6) 2016, THIS PATIENT UNDERWENT A SURGICAL REPAIR OF PERIPHERAL ARTERIAL DISEASE LOCATED IN THE COMMON FEMORAL ARTERY AND WAS TREATED WITH A GORE-TEX® STRETCH VASCULAR GRAFT, THE PATIENT RECEIVED HEPARIN AS AN ADDITIONAL ANTIPLATELET TREATMENT. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE, IT WAS ALSO RECORDED THAT THE PROCEDURE WAS UNEVENTFUL, THE DEVICE WAS IMPLANTED AND RETAINED, AND THAT THE PATIENT WAS DISCHARGED ON (B)(6), 2016. ON (B)(6) 2016, AN ADVERSE EVENT TERMED "HEMATOMA EVACUATION OF THE RIGHT SCARPA" WAS REPORTED. IT WAS RECORDED IN THE REGISTRY THAT THIS ADVERSE EVENT IS PROCEDURE-RELATED, REQUIRED AN INTERVENTION/TREATMENT AND RESOLVED WITHOUT SEQUALAE.

  Patient problems: Hematoma

  MAUDE report 17649065 ↗
• InjuryAug 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT THE PATIENT PRESENTED WITH A CRITICAL LIMB THREATENING ISCHEMIA DUE TO AN OCCLUSION OF THE LEFT SUPERFICIAL FEMORAL ARTERY HAS BEEN TREATED WITH A GORE-TEX® STRETCH VASCULAR GRAFT ON (B)(6) 2023. REPORTEDLY IN VIEW OF THE DEPTH AND EXTENT OF THE WOUNDS AND DUE TO THE VERY HIGH RISK OF A RAPID ADVERSE AND LIFE-THREATENING OUTCOME THE GRAFT WAS EXPLANTED DURING A MAJOR AMPUTATION ON (B)(6) 2023. FURTHERMORE IT WAS REPORTED THAT THE AMPUTATION WAS NOT ASSOCIATED WITH OCCLUSION/THROMBOSIS OF THE GRAFT.

  Patient problems: Insufficient Information; Ischemia

  MAUDE report 17628924 ↗
• InjuryAug 20, 2023Partial Blockage; No Apparent Adverse Event; Partial Blockage; No Apparent Adverse Event

  REPORTEDLY ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® STRETCH VASCULAR GRAFT TO TREAT AN OCCLUSIVE PERIPHERAL ARTERIAL DISEASE. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. REPORTEDLY ON (B)(6) 2016, AN ADVERSE EVENT TERMED "STENOSIS OF THE RIGHT FEMORAL BIFURCATION" WAS DISCOVERED, THE PRIMARY RELATIONSHIP WAS RECORDED AS PROCEDURE RELATED. A REINTERVENTION (NOT FURTHER SPECIFIED) WAS PERFORMED AND THE PATIENT RECOVERED WITHOUT A SEQUELAE.

  Patient problems: Stenosis

  MAUDE report 17581218 ↗
• InjuryAug 10, 2023Microbial Contamination of Device; Obstruction of Flow; Microbial Contamination of Device; Obstruction of Flow

  GORE RECEIVED AN ADVERSE EVENT ALERT FROM A RETROSPECTIVE VASCULAR GRAFT STUDY. IT WAS REPORTED THAT, ON (B)(6) 2015, THE PATIENT PRESENTED WITH AN OCCLUSION IN THE RIGHT LEG DUE TO PERIPHERAL ARTERY DISEASE (PAD, FONTAINE SCALE IV - ULCERATION OR GANGRENE) AND UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® VASCULAR GRAFT USED AS A FEMORO-POPLITEAL BYPASS. REPORTEDLY THERE WAS NO PRE-EXISTING INFECTION IN THE FIELD OF TREATMENT. HEPARIN WAS USED DURING THE PROCEDURE. THE GRAFT WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2015, THE PATIENT PRESENTED WITH DEHISCENCE OF THE INCISION SCAR AT THE ACCESS SITE WITHOUT THE GRAFT BEING EXTERNALLY EXPOSED. REPORTEDLY THE CAUSE FOR DEHISCENCE WAS INFECTION OF THE INCISION SITE BECAUSE OF CHRONIC SEPSIS OF AN ABDOMINAL PLAQUE AND UNDERNOURISHMENT. THE INFECTION OF THE INCISION SITE WAS REPORTEDLY RELATED TO THE PROCEDURE. THE INFECTION HAS SPREAD AND LED TO GRAFT INFECTION AND SEPTIC THROMBOSIS OF THE GRAFT SECONDARY TO GRAFT INFECTION. IT WAS REPORTED THAT BACTERIOLOGICAL TESTING CONFIRMED BACTERIAL INFECTION OF THE GRAFT. ON (B)(6) 2015, THE GRAFT WAS EXPLANTED DUE TO INFECTION AND THROMBOSIS. THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR 3 WEEKS. RE

  Patient problems: Bacteremia; Bacterial Infection; Post Operative Wound Infection; Thrombosis/Thrombus

  MAUDE report 17499226 ↗
• InjuryAug 7, 2023Fluid/Blood Leak; Fluid/Blood Leak

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® PROPATEN® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT WAS INTENDED FOR USE IN THE RIGHT PULMONARY ARTERY AS AN ANASTOMOSIS GRAFT. IT WAS REPORTED ON (B)(6) 2023, THE GORE® PROPATEN® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT WAS WEEPING AND A REINTERVENTION HAS BEEN PLANNED TO EXPLANT THE GRAFT. ON (B)(6) 2023, A REINTERVENTION WAS PERFORMED TO EXPLANT THE GORE® PROPATEN® VASCULAR GRAFT CONFIGURED FOR PEDIATRIC SHUNT. THE CASE WAS COMPLETED WITH A HOMOGRAFT. IT WAS REPORTED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Unspecified Heart Problem

  MAUDE report 17472752 ↗
• InjuryJul 21, 2023Microbial Contamination of Device; Microbial Contamination of Device

  ON (B)(6) 2015, A GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED FOR DIALYSIS ACCESS IN A STUDY PATIENT'S LEFT ARM. THE VASCULAR GRAFT WAS IMPLANTED FROM BRACHIAL ARTERY TO CEPHALIC VEIN WITH NO ISSUES. PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2015. AS REPORTED, THE MOST RECENT ACCESS PRIOR TO IMPLANT WAS A FISTULA IN THE PATIENT'S PROXIMAL LEFT ARM. THIS ACCESS WAS ABANDONED DUE TO STENOSIS. ON (B)(6) 2015, SURGICAL SITE INFECTION WAS OBSERVED. PER STUDY INFORMATION, THIS WAS A PROCEDURE-RELATED INFECTION THAT REQUIRED MEDICAL OR SURGICAL INTERVENTION. ON (B)(6) 2016, THE VASCULAR GRAFT WAS EXPLANTED DUE TO INFECTION THAT SPREAD TO THE VASCULAR GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Bacterial Infection; Post Operative Wound Infection

  MAUDE report 17373774 ↗

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