COVERA AVSM10080Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741106408), received between Feb 28, 2019 and Mar 31, 2026 — classified as 9 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Device Contamination with Chemical or Other Material

  ON (B)(6) 2026, A PATIENT WAS PREPPED FOR A STENT PLACEMENT PROCEDURE USING COVERA VASCULAR COVERED STENT. PRIOR TO THE PROCEDURE DURING OPENING THE BOX AND THE STERILE PACKAGING OF THE STENT GRAFT, A HUMAN HAIR OR UNKNOWN PIECE OF FUZZ OR STRING WAS IDENTIFIED ATTACHED TO THE STENT IN THE STERILE PACKAGING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24742740 ↗
• MalfunctionOct 27, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED DIFFICULTY ADVANCING THE STENT INTO THE PATIENT¿S FISTULA. IT WAS FURTHER REPORTED THAT TIP OF THE DELIVERY SYSTEM WAS DAMAGED PRIOR TO USE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23388633 ↗
• MalfunctionJul 9, 2025Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT A PATIENT'S FISTULA WAS FOUND CLOTTED 2 WEEKS AFTER PLACEMENT OF 10X80 MM STENT. THE 10X80 MM STENT WAS PLACED INSIDE A PREVIOUSLY STENT, WHICH WAS CONSIDERED BEING TOO SMALL, AND THEREFORE RUPTURED BY INTENTION; THE PREVIOUSLY STENT WAS RUPTURED USING A 10 MM BALLOON CATHETER. WHEN THE FISTULA WAS FOUND CLOTTED THROMBECTOMY WAS PERFORMED AND THE 10X80 MM STENT WAS FOUND PARTIALLY COLLAPSED. TWO ADDITIONAL 10X80 MM STENTS OF ANOTHER BRAND WERE PLACED TO IMPROVE THE RADIAL FORCE. PHYSICAL EXAMINATION DEMONSTRATED GOOD PULSE AND THRILL. FOLLOW UP ONE MONTH AND FOUR MONTH AFTER PLACEMENT OF THE ADDITIONAL STENT SHOWED THERE WAS NO STENOSIS IN THE STENTED SEGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456868 ↗
• InjuryApr 30, 2025Material Deformation; Material Deformation

  A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT. THE PATIENT HAD THE STENT PLACED ON 24 FEB 2025 AND WHEN HE COMEBACK FOR HIS NEXT APPOINTMENT ON (B)(6) 2025 IT WAS DISCOVERED DURING X-RAY EXAMINATION THAT THE STENT HAD COLLAPSED. THE PATIENT HAS BEEN REFERRED TO VASCULAR SURGERY. CURRENT STATUS OF THE PATIENT IS UNKNOWN.

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

  MAUDE report 21932865 ↗
• InjurySep 2, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY COMPRESSED AFTER IT WAS DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FRACTURED WHICH CAUSED THROMBOSIS IN PATIENT. HOWEVER, THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20117083 ↗
• InjuryAug 21, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY COMPRESSED AFTER IT WAS DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FRACTURED WHICH CAUSED THROMBOSIS IN PATIENT. HOWEVER, THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20009194 ↗
• InjuryJun 25, 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 TWO YEARS, FOUR MONTHS, AND TWENTY-TWO DAYS POST A COVERED STENT GRAFT PLACEMENT, THE SUBJECT DEVELOPED TARGET LESION STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED TO TREAT THE TARGET LESION. THE TREATMENT REINTERVENTION WAS SUCCESSFUL AND THE OUTCOME WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 19605142 ↗
• InjuryJul 25, 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 TWO YEARS AND EIGHT DAYS POST STENT PLACEMENT, THE SUBJECT DEVELOPED AN ADVERSE EVENT OF THROMBOSIS OF STUDY VASCULAR ACCESS WHICH REQUIRED PROLONGED HOSPITALIZATION. REPORTEDLY, THE SUBJECT HAD A CATHETER PLACEMENT AND THE DETERMINED ACCESS WAS ABANDONED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17387258 ↗
• MalfunctionJul 10, 2023Break; Positioning Failure; Entrapment of Device; Break; Positioning Failure; Entrapment of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA LEFT ATRIOVENTRICULAR FISTULA, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT DELIVERY SYSTEM GOT CAUGHT ON THE STENT GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285128 ↗
• MalfunctionApr 19, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THREE MONTHS AND ELEVEN DAYS POST STENT PLACEMENT, THE STENT WAS ALLEGEDLY FOUND TO BE KINKED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16769690 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT ALLEGEDLY EXPERIENCED PAIN AND SWELLING SYMPTOMS TWELVE DAYS AFTER PLACEMENT OF A COVERED STENT, THE STENT WAS PLACED ON THE ARM PIT VEIN. IT WAS FURTHER REPORTED THAT PATIENT EXPERIENCED PAIN AND SWELLING. REPORTEDLY, THE PHYSICIAN IDENTIFIED THE FISTULA WAS HIGHLY PRESSURIZED AND IT WAS DECIDED TO SURGICALLY EXPLANT THE STENT. AS REPORTED THE PATIENT GOT IN A STABLE CONDITION.

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

  MAUDE report 16562679 ↗
• InjuryMay 23, 2022Obstruction of Flow; Material Twisted/Bent; Obstruction of Flow; Material Twisted/Bent

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY ONE MONTH THREE DAYS POST INDEX STENT PLACEMENT PROCEDURE, PATIENT HAD AN ADVERSE EVENT OF COLLAPSED STENT AND TARGET LESION RESTENOSIS. IT WAS FURTHER REPORTED THAT STANDARD PTA WAS PERFORMED. TWO DAYS LATER THE COLLAPSED COVERED STENT WAS SURGICALLY REMOVED AND ANOTHER STENT WAS PLACED; THE PROCEDURE WAS SUCCESSFUL. THE CURRENT STATUS OF THE PATIENT IS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 14470675 ↗
• InjuryDec 16, 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 NINE MONTHS POST INDEX PROCEDURE, THE PATIENT DEVELOPED 60% 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 13015796 ↗
• MalfunctionJul 14, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING THE STENT GRAFT PLACEMENT, HE DEVICE ALLEGEDLY HAD MALPOSITION ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12164764 ↗
• MalfunctionMar 22, 2019Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT UPON OPENING OF THE DEVICE PACKAGING, THE STERILE BARRIER ALLEGEDLY WAS PULLED BACK OR NOT SEALED PROPERLY IN THE UPPER RIGHT HAND CORNER OF THE INNER PACKAGE. THEREFORE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Patient Involvement

  MAUDE report 8446057 ↗
• InjuryFeb 28, 2019Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY SIX DAYS AFTER THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED THE HEALTHCARE PROVIDER (HCP) WAS PERFORMING AN INTERVENTION (UNRELATED TO THE DEVICE) TO TREAT A CTO AND AFTER SUCCESSFULLY CROSSING THE STENT GRAFT, AFTER BALLOON ANGIOPLASTY, THE HCP IDENTIFIED VIA AN ANGIOGRAM THAT THE INNER LAYER OF THE EPTE COATING WAS ALLEGEDLY SEPARATED FROM THE INNER PORTION OF THE STENT GRAFT. REPORTEDLY, THE STENT GRAFT WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED BY CATHETER INSERTION IN THE RIGHT CHEST. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; Reocclusion

  MAUDE report 8380040 ↗