COVERA AVSM08060Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741106293), received between Jul 15, 2019 and Mar 16, 2026 — classified as 11 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 reports).

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 22, 2022Open, Classified

   An increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding.

   Z-1108-2023 · Root cause: Unknown/Undetermined by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Difficult or Delayed Positioning; Malposition of Device

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A COVERA VASCULAR COVERED STENT. IT WAS REPORTED THAT DURING THE PROCEDURE THE STENT WAS ALLEGEDLY FULLY DEPLOYED ALL AT ONCE AFTER ONE TURN OF THE BIG WHEEL, CAUSING INACCURATE PLACEMENT OF THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603011 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL STUDY THAT APPROXIMATELY ONE YEAR. ELEVEN MONTHS, AND TEN DAYS LATER THE SUBJECT UNDERWENT A RE-INTERVENTION FOR TARGET LESION RE-STENOSIS ON THE CEPHALIC VEIN OF THE LEFT ARM, THE TARGET LESION WAS TREATED ON THE CEPHALIC VEIN ARCH REGION WITH INITIAL STENOSIS% OF 80% AND FINAL RESIDUAL STENOSIS OF 0%. IT WAS FURTHER REPORTED THAT THE SUBJECT UNDERWENT RE-INTERVENTION FOR TARGET LESION RE-STENOSIS AND PROLONGED BLEEDING. THE TARGET LESION WAS TREATED ON THE CEPHALIC VEIN ARCH REGION WITH INITIAL STENOSIS% OF 80.1% AND FINAL RESIDUAL STENOSIS OF 20%. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pain; Restenosis

  MAUDE report 23017413 ↗
• InjuryAug 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL STUDY THAT APPROXIMATELY EIGHT MONTHS, FOUR WEEKS AND A DAY LATER THE SUBJECT UNDERWENT A RE-INTERVENTION FOR ACCESS THROMBOSIS AND TARGET LESION RE-STENOSIS ON THE RIGHT ARM. THE TARGET LESION WAS TREATED ON THE CEPHALIC VEIN ARCH REGION WITH INITIAL STENOSIS OF 80% AND FINAL RESIDUAL STENOSIS OF 0%. IT WAS FURTHER REPORTED THAT THE SUBJECT UNDERWENT RE-INTERVENTION FOR TARGET LESION RE-STENOSIS. THE TARGET LESION WAS TREATED ON THE CEPHALIC VEIN ARCH REGION WITH INITIAL STENOSIS OF 95% AND FINAL RESIDUAL STENOSIS OF 0%. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 22892569 ↗
• MalfunctionOct 24, 2024Break; Positioning Failure; Material Separation; Break; Positioning Failure; Material Separation

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE RED SAFETY LOCK ALLEGEDLY HAD BROKEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20522349 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT SIX MONTHS AND FIFTEEN DAYS POST A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT IN THE CEPHALIC VEIN AT CEPHALIC VEIN ARCH VIA THE RIGHT UPPER ARM ACCESS, THE SUBJECT HAD AN ADVERSE EVENT OF METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS GRAM-POSITIVE BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT ONE YEAR, THREE MONTHS, AND TWENTY-FOUR DAYS POST A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT, THE SUBJECT HAD SERIOUS ADVERSE EVENT OF KINK IN CEPHALIC VEIN CAUSING STENOSIS IN THE MID ARM APPROXIMATELY TWELVE CENTIMETERS PROXIMAL TO THE STENT. SURGICAL REVISION WAS PERFORMED TO TREAT THE KINK IN CEPHALIC VEIN CAUSING STENOSIS IN THE MID ARM APPROXIMATELY TWELVE CENTIMETERS PROXIMAL TO THE STENT. TREATMENT RE-INTERVENTION WAS SUCCESSFUL AND NO NEW ACCESS CREATED. REPORTEDLY, THE OUTCOME OF THE SERIOUS ADVERSE EVENT WAS RESOLVED. IT WAS ALSO REPORTED THAT ONE YEAR, FOUR MONTHS, AND THREE DAYS POST A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT, THE SUBJECT HAD CEPHALIC VEIN RESTENOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION DUE TO ELEVATED VENOUS PRESSURES AND PULSATILITY. STANDARD PERCUTANEOUS

  Patient problems: Bacterial Infection; Restenosis; Stenosis

  MAUDE report 19757957 ↗
• MalfunctionMay 29, 2024Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT FULLY DEPLOY. REPORTEDLY, AFTER SOME MANEUVERING, THE STENT WAS ABLE TO BE DEPLOYED BUT ALLEGEDLY MISSED THE SITE OF TARGET. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19412780 ↗
• InjuryApr 15, 2024Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT SIX MONTHS AND FIFTEEN DAYS POST A STENT GRAFT PLACEMENT IN THE CEPHALIC VEIN AT CEPHALIC VEIN ARCH VIA THE RIGHT UPPER ARM, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS BACTERIAL INFECTION. IT WAS FURTHER REPORTED THAT ONE YEAR, THREE MONTHS, AND TWENTY-FOUR DAYS POST A STENT GRAFT PLACEMENT, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF KINK IN FISTULA CAUSING STENOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION. SURGICAL REVISION WAS PERFORMED FOR TREATMENT. TREATMENT REINTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME WAS RESOLVED. IT WAS ALSO REPORTED THAT ONE YEAR FOUR MONTHS AND THREE DAYS POST A STENT GRAFT PLACEMENT, THE SUBJECT DEVELOPED A TARGET LESION RESTENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT THE TARGET LESION. TREATMENT REINTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacterial Infection; Restenosis

  MAUDE report 19104520 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL THAT TWO MONTHS AND TWENTY-SIX DAYS POST VASCULAR COVERED STRAIGHT STENT PLACEMENT IN THE CEPHALIC VEIN AT ANASTOMOTIC VIA THE RIGHT UPPER ARM ACCESS, THE SUBJECT DEVELOPED AN ACCESS CIRCUIT THROMBOSIS WHICH REQUIRED ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION. IT WAS FURTHER REPORTED THAT FOUR MONTHS AND NINE DAYS POST VASCULAR COVERED STRAIGHT STENT PLACEMENT IN THE CEPHALIC VEIN AT CEPHALIC VEIN ARCH VIA THE RIGHT UPPER ARM ACCESS, THE SUBJECT DEVELOPED AN ACCESS CIRCUIT THROMBOSIS AND TARGET LESION RESTENOSIS WHICH REQUIRED ADDITIONAL ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION. IT WAS ALSO REPORTED THAT STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON CATHETER PROCEDURE AND THROMBECTOMY WERE PERFORMED TO TREAT THE ACCESS CIRCUIT THROMBOSIS AND ACCESS CIRCUIT STENOSIS. FURTHERMORE, THE TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NEW ACCESS WAS NOT CREATED, AND THE SUBJECT RECOVERED. REPORTEDLY, THE SUBJECT EXPIRED, AND THE PRIMARY CAUSE OF DEATH WAS CARDIAC ARREST. APPARENTLY, THERE HAVE BEEN NO DOCUMENTED DEVICE DEFICIENCIES, AND NO ADVERSE EVENTS WERE REPORTED, AND THE RELATIONSHIP OF THE DEATH WAS NOT R

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 18371491 ↗
• MalfunctionApr 26, 2023Positioning Failure; Misfire; Detachment of Device or Device Component; Positioning Failure; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16813178 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT ONE YEAR AND TWENTY-TWO DAYS POST INDEX PROCEDURE, CORE LAB RESULT ANALYSIS IDENTIFIED THE TARGET LESION AT CEPHALIC VEIN ARCH LOCATION HAD A MAXIMUM LESION STENOSIS OF FIFTY EIGHT PERCENT. STANDARD PTA WAS USED FOR TREATMENT. TREATMENT REINTERVENTION WAS SUCCESSFUL, AND THE PATIENT RECOVERED WITH FINAL RESIDUAL STENOSIS OF TWENTY PERCENT. HOWEVER, THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 16264020 ↗
• MalfunctionJan 20, 2023Loss of or Failure to Bond; Positioning Failure; Material Deformation; Loss of or Failure to Bond; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16215650 ↗
• MalfunctionJul 21, 2022Loss of or Failure to Bond; Break; Positioning Failure; Loss of or Failure to Bond; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15071365 ↗
• MalfunctionJun 29, 2022Loss of or Failure to Bond; Positioning Failure; Misfire; Loss of or Failure to Bond; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA RIGHT UPPER ARM FISTULA, THE STENT ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14850272 ↗
• MalfunctionApr 26, 2022Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE INTO THE SUBCLAVIAN VEIN, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14202671 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY TWO MONTHS AND NINETEEN DAYS POST INDEX PROCEDURE, APPROXIMATELY SIX MONTHS AND TWELVE DAYS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED AND STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Numbness; Restenosis; Thrombosis/Thrombus

  MAUDE report 12809835 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY THREE MONTHS AND TWENTY TWO DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 25% OF TARGET LESION STENOSIS. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 12808952 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE MONTH AND EIGHT DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 50% OF TARGET LESION STENOSIS. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 12653179 ↗
• MalfunctionAug 20, 2021Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging; Device Damaged Prior to Use; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT PRIOR TO THE PLACEMENT OF STENT GRAFT, THE PACKAGE OF THE DEVICE WAS ALLEGEDLY DAMAGED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12347136 ↗
• MalfunctionApr 8, 2020Malposition of Device; Malposition of Device

  THE REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL AVSM08060, VASCULAR COVERED STENT, ALLEGEDLY EXPERIENCED MALPOSITION OF THE DEVICE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941539 ↗
• InjuryJul 16, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY 6-MONTH POST INDEX PROCEDURE, 70% TARGET LESION STENOSIS WITH DIMINISHED OR ABNORMAL THRILL WERE IDENTIFIED AND STANDARD PTA AND THROMBECTOMY WERE PERFORMED TO TREAT THE LESION. IT WAS FURTHER REPORTED APPROXIMATELY 1 YEAR 6-MONTH POST INDEX PROCEDURE STENOSIS WAS IDENTIFIED AND STANDARD PTA AND THROMBECTOMY (THROMBOASPIRATION) WERE PERFORMED TO TREAT THE LESION. THE RE-INTERVENTION WAS SUCCESSFUL.

  Patient problems: Stenosis

  MAUDE report 8795334 ↗
• InjuryJul 15, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, APPROXIMATELY 10-MONTH POST INDEX PROCEDURE DECREASED ACCESS BLOOD FLOW WAS IDENTIFIED. A STANDARD PTA AND THROMBECTOMY WERE PERFORMED TO TREAT THE STENOSIS IN THE TARGET LESION. IT WAS FURTHER REPORTED APPROXIMATELY 1 YEAR 2-MONTH POST INDEX PROCEDURE DECREASED ACCESS BLOOD FLOW WITH STENOSIS IN THE TARGET LESION (BRACHIAL). STANDARD PTA WAS USED TO TREAT THE LESION. IT WAS REPORTED APPROXIMATELY 1 YEAR 8-MONTH POST INDEX PROCEDURE STENOSIS IN THE TARGET LESION. STANDARD PTA AND STENT GRAFT WERE USED TO TREAT THE LESION. IT WAS FURTHER REPORTED APPROXIMATELY 24-MONTH POST INDEX PROCEDURE DECREASED ACCESS BLOOD FLOW WITH STENOSIS IN THE TARGET LESION. STANDARD PTA WAS USED TO TREAT THE LESION.

  Patient problems: Stenosis

  MAUDE report 8790175 ↗