GORE-TEX Stretch Vascular GraftRecalls & reported problems across all models

We found 10 models of GORE-TEX Stretch Vascular Graft by W. L. Gore & Associates, Inc. in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Jul 23, 2019 and Jul 12, 2024 — classified as 22 injuries.

The most frequently reported specific device problem is “Microbial Contamination of Device” (4 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 Stretch Vascular Graft problems

GORE-TEX Stretch Vascular Graft models

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

• GORE-TEX Stretch Vascular Graft S0604

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  8 reports
• GORE-TEX Stretch Vascular Graft SAX01D

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  4 reports
• GORE-TEX Stretch Vascular Graft S0607

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• GORE-TEX Stretch Vascular Graft S46045

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  2 reports
• GORE-TEX Stretch Vascular Graft S0504

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Stretch Vascular Graft S0508

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Stretch Vascular Graft S0602

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Stretch Vascular Graft S46048

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Stretch Vascular Graft SA1603

  PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
  1 report
• GORE-TEX Stretch Vascular Graft SA2404

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

Recent GORE-TEX Stretch Vascular Graft adverse event reports

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

• InjuryJul 12, 2024Microbial Contamination of Device; Device Stenosis; Microbial Contamination of Device; Device Stenosis

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT FOR AN ACUTE ISCHEMIA OF THE LOWER LIMBS WITH A GORE-TEX® STRETCH VASCULAR GRAFT - STANDARD-WALLED AXILLOBIFEMORAL REMOVABLE RINGED. THE GRAFT WAS IMPLANTED ON (B)(6) 2023, AS AN AXILLO-BI-FEMORAL BYPASS. IT WAS STATED THAT ON (B)(6) 2024, THE PATIENT PRESENTED TO EMERGENCY WITH A SIGNIFICANT BIOLOGICAL INFLAMMATORY SYNDROME AND THE BYPASS WAS THROMBOSED. A BYPASS THROMBECTOMY WAS PERFORMED ON (B)(6) 2024. SAMPLES WERE TAKEN AND FOUND TO CONTAIN A BACTERIODES FRAGILIS INFECTION, WHICH JUSTIFIED ANTI-BIOTHERAPY WITH CLINDAMYCIN. ON (B)(6) 2024, AFTER ABOUT 8 MONTHS, THE GRAFT WAS EXPLANTED FOR INFECTION AND A NEW REVASCULARISATION PROCEDURE. THE SURGEON NOTICED THAT THE DEVICE WAS THROMBOSED. A NEW RIGHT-SIDED AXILLO-FEMORAL BYPASS ASSOCIATED WITH A LEFT SUBARTICULAR FEMORO-POPLITEAL BYPASS WAS CREATED. THE PATIENT WENT INTO POSTOPERATIVE SHOCK WITH NEW THROMBOSIS OF THE BYPASS GRAFT, WITH NO POSSIBILITY OF SURGICAL INTERVENTION. COMFORT CARE WAS INITIATED, AND THE PATIENT DIED ON (B)(6) 2024.

  Patient problems: Bacterial Infection; Thrombosis/Thrombus

  MAUDE report 19727962 ↗
• InjuryDec 11, 2023Partial Blockage; Partial Blockage

  THE FOLLOWING WAS REPORTED TO GORE: MY CHILD WAS IMPLANTED WITH A ¿MASA VALVE¿ IN 2017 BUILT WITH THE OFF LABEL USE OF GORETEX STRETCH GRAFT AND PRECLUDE PERICARDIAL MEMBRANE. THE VALVE FAILED IN 2021. MULTIPLE ISSUES WERE IDENTIFIED BY THE SURGEON WHO REMOVED THE MASA VALVE, ONE: THE STITCHING OF THE SUTURES OF A LEAFLET TEARING AND THE LEAFLET ¿WAS FLOPPING IN THE WIND¿ WOULD YOU BE ABLE TO HELP MY SON AND I FILE A MAUDE ADVERSE EVENT REPORT? IT IS NOT YOUR PRODUCT THAT FAILED BUT THE OFF LABEL USE BY THE SURGEONS WHO FAILED TO GIVE INFORMED CONSENT THAT FAILED MY CHILD. ADDITIONAL INFORMATION RECEIVED ON DECEMBER 6, 2023: DATE OF IMPLANT (B)(6), 2017. PATIENT HAD CHF IN (B)(6) 2022. VALVE HAD FAILED FEBRUARY 2022, LEAFLETS SUTURES HAD COME LOOSE "FLOPPING" IN THE WIND, ALSO CALCIUM BUILDUP AND STENOSIS OF THE CONDUIT. THE DEVICES WERE EXPLANTED ON (B)(6), 2022. IT WAS REPORTED IT WAS A ROSS PROCEDURE. REGURGITIVE AORTIC VALVE - SURGEON RECOMMENDED MASA VALVE IN PLACE OF PULMONARY VALVE. ADDITIONAL NOTE: IT WAS REPORTED ON DECEMBER 7, 2023 THAT THE PATIENT IS DOING WELL.

  Patient problems: Stenosis

  MAUDE report 18305058 ↗
• InjuryOct 16, 2023Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available; Patient-Device Incompatibility; Appropriate Device Problem Term/Code Not Available

  GORE RECEIVED AN ADVERSE EVENT ALERT FROM A RETROSPECTIVE VASCULAR GRAFT STUDY. ON JUNE 4, 2019, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE CREATION OF A VASCULAR ACCESS GRAFT FOR HEMODIALYSIS BRACHIO-BASILIC IN THE LEFT ARM WITH A GORE-TEX® STRETCH VASCULAR GRAFT. THE DEVICE WAS IMPLANTED AND RETAINED AND THERE WERE NO ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME TWO DAYS LATER. ON (B)(6) 2019, THE PATIENT PRESENTED WITH A VASCULAR STEAL SYNDROME WHICH NEEDS MEDICAL OR SURGICAL INTERVENTION. THE ISSUE WAS RESOLVED ON (B)(6) 2019, BY CLOSING OF THE LEFT BRACHIO-BASILIC PROSTHETIC LINE. THE FULL DEVICE WAS EXPLANTED AS PART OF THE REINTERVENTION. AS PRIMARY RELATIONSHIP PROCEDURE-RELATED WAS MENTIONED.

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

  MAUDE report 17937970 ↗
• InjurySep 4, 2023Contamination; Contamination

  GORE RECEIVED AN ADVERSE EVENT ALERT FROM A RETROSPECTIVE VASCULAR GRAFT STUDY. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE CREATION OF A VASCULAR ACCESS GRAFT BRACHIO-BASILIC IN THE LEFT ARM FOR HEMODIALYSIS WITH A GORE-TEX® STRETCH VASCULAR GRAFT, BECAUSE OF AN ACCESS SITE INFECTION OF A JUGULAR CATHETER. THE DEVICE WAS IMPLANTED AND RETAINED AND THERE WERE NO ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2016, AND THE FIRST ORDER TO DIALYZE THROUGH THE GRAFT SUCCESSFULLY WAS ON (B)(6) 2016. ON (B)(6) 2016, THE PATIENT PRESENTED WITH AN INFECTION OF THE PROSTHETIC LOOP GRAFT. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED, AND TREATMENT REQUIRED. THE ISSUE WAS RESOLVED ON (B)(6) 2016. THE STUDY WAS DISCONTINUED, AS THE DEVICE WAS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17676110 ↗
• InjurySep 4, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  GORE RECEIVED AN ADVERSE EVENT ALERT FROM A RETROSPECTIVE VASCULAR GRAFT STUDY. ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR A HUMERO AXILLARY DIALYSIS ACCESS WITH A GORE-TEX® STRETCH VASCULAR GRAFT. THE DEVICE WAS IMPLANTED AND RETAINED AND THERE WERE NO ADVERSE EVENTS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED HOME 1 WEEK LATER. THE FIRST ORDER TO DIALYZE THROUGH THE GRAFT WAS ON (B)(6) 2016 AND WAS SUCCESSFUL. ON (B)(6) 2016, THE PATIENT PRESENTED WITH A VASCULAR STEAL SYNDROME ON THE HUMERO-AXILLARY PROSTHETIC LINE. PROFESSOR RINCKENBACH STATED THAT THERE IS NO ALLEGATION AGAINST THE GORE-TEX STRETCH VASCULAR GRAFT AND THAT THE GRAFT DID NOT CONTRIBUTE TO THE STEAL SYNDROME. THERE WAS A REINTERVENTION ON (B)(6) 2016, NAMELY BANDING OF THE ARTERIO-VENOUS ANASTOMOSIS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2016 AND AN ULTRASOUND PERFORMED ON (B)(6) 2016 SHOWED THAT EVERYTHING WAS OK.

  Patient problems: Reduced Blood Flow

  MAUDE report 17675909 ↗
• InjuryAug 30, 2023Partial Blockage; Complete Blockage; Partial Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE CREATION OF A VASCULAR ACCESS GRAFT FOR HEMODIALYSIS WITH A GORE-TEX® VASCULAR GRAFT, THE ACCESS CONFIGURATION WAS RECORDED AS HUMERO-AXILLARY CONFIGURATION. DURING THE PROCEDURE ANTICOAGULANT / ANTIPLATELET WAS USED AND THE DEVICE WAS IMPLANTED; RETAINED SUCCESSFULLY AND NO ADVERSE EVENT WAS REPORTED DURING THE PROCEDURE. ON (B)(6) 2016, AN ADVERSE EVENT TERMED "THROMBOSIS OF THE LEFT HUMERO-AXILLARY PROSTHETIC LINE (GORE GRAFT THROMBOSED))" WAS DISCOVERED AND THE PRIMARY RELATIONSHIP WAS RECORDED AS DISEASE RELATED. NO REINTERVENTION WAS PERFORMED AND THE PATIENT RECOVERED WITHOUT A SEQUELEA.

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 17649140 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2019, THE PATIENT UNDERWENT SURGICAL TREATMENT FOR THE CREATION OF A VASCULAR ACCESS GRAFT FOR HEMODIALYSIS WITH A GORE-TEX® STRETCH VASCULAR GRAFT. DURING THE PROCEDURE ANTICOAGULANT / ANTIPLATELET WAS USED AND THE DEVICE WAS IMPLANTED AND RETAINED SUCCESSFULLY. ON (B)(6) 2019, AN ADVERSE EVENT TERMED HEMATOMA AFTER THE CREATION OF HUMERO-AXILLARY PROSTHETIC LINE WAS DISCOVERED AND THE PRIMARY RELATIONSHIP WAS RECORDED AS PROCEDURE RELATED. A REINTERVENTION IN THE FORM OF A REVISION SURGERY WAS PERFORMED AND THE PATIENT RECOVERED WITHOUT A SEQUELEA. ACCORDING TO REPORTS ON (B)(6) 2020, ANOTHER ADVERSE EVENT TERMED FALSE ANEURYSM ON THE RIGHT PROSTHETIC HUMERO AXILLARY LINE WAS RECORDED. THE PRIMARY RELATIONSHIP WAS RECORDED AS DISEASE RELATED AND THE PATIENT RECOVERED WITHOUT A SEQUELEA AFTER AN UNSPECIFIED REINTERVENTION WAS PERFORMED.

  Patient problems: Aneurysm; Hematoma; Pseudoaneurysm

  MAUDE report 17649120 ↗
• InjuryJul 24, 2023Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2018, A GORE-TEX® STRETCH VASCULAR GRAFT (VASCULAR GRAFT) WAS IMPLANTED IN A STUDY PATIENT IN A DIALYSIS ACCESS APPLICATION. THE IMPLANT WAS IN THE PATIENT'S LEFT ARM, FROM THE BRACHIAL ARTERY TO CEPHALIC VEIN. ON (B)(6) 2018, THE VASCULAR GRAFT WAS REPORTEDLY ABANDONED DUE TO REPEATED THROMBOSIS. DATE(S) OF THROMBOSIS WERE NOT PROVIDED. ON (B)(6) 2018, A RIGHT BRACHIAL TO CEPHALIC ARTERIOVENOUS FISTULA WAS CREATED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17383414 ↗
• InjuryJul 20, 2023Partial Blockage; Partial Blockage

  FROM A CLINICAL STUDY THE FOLLOWING INFORMATION WAS OBTAINED: ON (B)(6) 2018, A GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED IN A DIALYSIS ACCESS APPLICATION. THE IMPLANT WAS IN THE STUDY PATIENT'S LEFT ARM (BRACHIAL TO BRACHIAL). ON (B)(6) 2018, THROMBOSIS OF THE VASCULAR GRAFT (PROSTHETIC LINE) WAS REPORTED. INTERVENTION WAS PERFORMED. THE REPORTED ISSUE WAS LISTED AS DISEASE-RELATED AND RESOLVED WITHOUT SEQUELAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17358236 ↗
• InjuryJul 5, 2023Complete Blockage; Complete Blockage

  REPORTEDLY ON (B)(6) 2023, THIS PATIENT UNDERWENT SURGICAL TREATMENT WITH A GORE-TEX® STRETCH VASCULAR GRAFT IN ORDER TO CREATE A HEMODYLIASIS ACCESS. THE ACCESS CONFIGURATION WAS RECORDED TO BE A RIGHT HAND HUMORO-AXILLARY BYPASS. IT WAS RECORDED THAT ON THE SAME DAY, AN ADVERSE EVENT TERMED "EARLY THROMBOSIS" WAS DISCOVERED AND REINTERVENTION WAS PERFORMED. THE PATIENT RECOVERED WITHOUT A SEQUALAE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17261604 ↗
• InjuryMay 23, 2023Microbial Contamination of Device; Microbial Contamination of Device

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT A MINIMALLY INVASIVE PROCEDURE WITH ROBOTIC SURGERY IN WHICH A GORE-TEX® STRETCH VASCULAR GRAFT WAS USED. REPORTEDLY, THE PROSTHESIS WAS IMPLANTED ON AUGUST 8, 2013, AS A PROSTHETIC AORTO BI-ILIAC GRAFT, IN ORDER TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2023, AFTER ABOUT 9 YEARS AND 6 MONTHS, THE PROSTHESIS WAS EXPLANTED DUE TO AN INFECTION (ESCHERICHIA COLI).

  Patient problems: Bacterial Infection

  MAUDE report 16983958 ↗
• InjuryMar 22, 2023Complete Blockage; Complete Blockage

  REPORTEDLY, ON (B)(6) 2020, THIS PATIENT UNDERWENT SURGICAL TREATMENT FOR A DISTAL AORTIC OCCLUSION WHICH CAUSED LOWER LIMB ISCHEMIA. A GORE-TEX® STRETCH VASCULAR GRAFT WAS USED IN THIS PROCEDURE. REPORTEDLY, ON (B)(6) 2022, AFTER 2 YEARS AND 2 MONTHS, A PART OF THE GRAFT WAS EXPLANTED DURING A NEW SURGICAL PROCEDURE DUE TO STENOSIS.

  Patient problems: Stenosis

  MAUDE report 16589329 ↗
• InjuryMar 22, 2023Microbial Contamination of Device; Microbial Contamination of Device

  REPORTEDLY, ON (B)(6) 2007, THIS PATIENT UNDERWENT AN AXILOFEMORAL BYPASS PROCEDURE IN ORDER TO TREAT A LEFT LOWER LIMB ISCHEMIA (POST RADIOTHERAPY). ACCORDING TO RECORDS ON (B)(6) 2022 AFTER ABOUT 14 YEARS AND 8 MONTHS, THE PROSTHESIS WAS EXPLANTED DUE TO AN INFECTION (CANDIDA ALBICANS).

  Patient problems: Fungal Infection

  MAUDE report 16589284 ↗
• InjuryOct 1, 2022Microbial Contamination of Device; Microbial Contamination of Device

  THE PATIENT PRESENTED WITH A CRITICAL ISCHEMIA BECAUSE OF STENOSIS (80 %) OF THE LEFT INTERNAL CAROTID ARTERY DUE TO CHRONIC ATHEROSCLEROTIC ARTERIAL DISEASE. REPORTEDLY, THE PATIENT HAD NO HISTORY OF SYSTEMIC INFECTION OR PREEXISTING INFECTION IN THE TREATMENT AREA. ON (B)(6) 2021, A GORE-TEX® STRETCH VASCULAR GRAFT WAS IMPLANTED AS A CAROTIDO-CAROTID BYPASS FROM THE RIGHT SIDE TO THE LEFT SIDE TO TREAT THE CRITICAL ISCHEMIA. THE ANASTOMOSES WERE AT THE RIGHT CAROTID BIFURCATION AND AT THE LEFT INTERNAL CAROTID ARTERY DISTALLY OF THE LESION. ON (B)(6) 2022, THE GRAFT WAS EXPLANTED DUE TO AN INFECTION. IT REMAINS UNKNOWN WHEN THE INFECTION WAS FIRST IDENTIFIED AND WHICH BACTERIA CONTRIBUTED TO THE INFECTION. IT REMAINS ALSO UNKNOWN WHAT FURTHER TREATMENTS WERE PERFORMED TO RESOLVE THE INFECTION. REPORTEDLY, THE PHYSICIAN DID NOT PROVIDE ANY INFORMATION AS TO WHY THE GRAFT BECAME INFECTED. IT WAS REPORTED THAT THE PHYSICIAN HAS NO SUSPICION THAT THE GORE GRAFT OR THE PROCEDURE CONTRIBUTED TO THE INFECTION.

  Patient problems: Bacterial Infection

  MAUDE report 15525966 ↗
• InjuryApr 26, 2022Contamination; Contamination

  IT WAS REPORTED TO GORE THAT THE PATIENT UNDERWENT SURGICAL TREATMENT TO CREATE AN ACCESS FOR HEMODIALYSIS WITH A GORE-TEX® STRETCH VASCULAR GRAFT ¿ STANDARD-WALLED. IT WAS STATED THAT THE VASCULAR GRAFT WAS IMPLANTED ON (B)(6) 2021. IT WAS REPORTED THAT ON (B)(6) 2021, AFTER ABOUT 4 MONTHS, THE VASCULAR GRAFT WAS EXPLANTED DUE TO INFECTION WITH STAPHYLOCOCCUS AUREUS MÉTI-R. A SEGMENT OF THE GRAFT WAS SENT FOR ANALYSIS.

  Patient problems: Bacterial Infection

  MAUDE report 14201693 ↗

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