COVERA AVSM08040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741106286), received between Jul 15, 2020 and Aug 27, 2025 — classified as 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Misfire” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 27, 2025Malposition of Device; Malposition of Device

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT VIA BASILIC VEIN. THE STENT PREMATURELY EXITED THE DELIVERY SHEATH WHEN IT WAS APPROXIMATELY HALFWAY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22901498 ↗
• InjuryMar 14, 2025Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST A STENT GRAFT PLACEMENT, THE STENT HAD ALLEGEDLY CAUSED OCCLUSION IN THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 21603292 ↗
• MalfunctionFeb 28, 2025Misfire; Material Deformation; Activation Failure; Misfire; Material Deformation; Activation Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DISTAL END OF THE STENT ALLEGEDLY DID NOT OPEN UPON DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE STENT WAS BALLOONED WHICH IMPROVED THE RESULT BUT WAS STILL NOT COMPLETELY OPEN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21488333 ↗
• InjuryJul 28, 2023Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE FISTULA VIA FISTULA VENOUS ACCESS, THE STENT WAS ALLEGEDLY PLACED AND IMMEDIATELY CLOTTED THE ENTIRE ACCESS. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

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

  MAUDE report 17412451 ↗
• MalfunctionJan 23, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16222628 ↗
• InjuryApr 25, 2022Adverse 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 ELEVEN MONTHS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED AND STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT STATUS OF THE SUBJECT WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 14192377 ↗
• 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 SIX MONTHS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 80% OF TARGET LESION STENOSIS. 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 12653182 ↗
• InjurySep 14, 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 POST INDEX PROCEDURE, THE SUBJECT DEVELOPED LEFT SHOULDER PAIN. APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 100% OF TARGET LESION STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Pain; Stenosis

  MAUDE report 12466022 ↗
• InjuryAug 26, 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 TWO YEARS AND FIVE MONTHS POST INDEX PROCEDURE, NEW LESION STENOSIS WAS OBSERVED AND COVERA VASCULAR COVERED STENT WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE PATIENT WAS DIAGNOSED WITH RIGHT HAND ISCHEMIA RELATED TO STUDY PROCEDURE AND DEVICE. THE PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Ischemia

  MAUDE report 12369763 ↗
• MalfunctionJul 15, 2020Packaging Problem; Packaging Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM08040.A COVERA VASCULAR COVERED STENT SYSTEM ALLEGEDLY EXPERIENCED PACKAGING PROBLEM. THE MALFUNCTION HAD NO PATIENT INVOLVEMENT AND THE PATIENT HAD NO CONSEQUENCES. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE; HOWEVER, THE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 10276338 ↗