COVERA AVFM10100Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00801741106613), received between Oct 16, 2020 and Jul 19, 2026 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions; Reduced Blood Flow

  MAUDE report 25867847 ↗
• MalfunctionMay 5, 2025Misfire; Material Deformation; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE 10X100 FLARED COVERA NOT DEPLOY. IT WAS FURTHER REPORTED THAT PART OF THE STENT STARTED TO DEPLOY BUT THEN NEVER COMPLETELY DETACHED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21961865 ↗
• InjuryApr 8, 2025Material Deformation; Material Deformation

  A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT. DURING THE PROCEDURE, THE STENT BEING USED FOLDED ON ITSELF. ANOTHER COVERA WAS NEEDED TO OPEN UP THE CRUSHED COVERA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 21794479 ↗
• MalfunctionJun 2, 2023Break; Misfire; Break; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN LEFT BASILIC VEIN VIA LEFT UPPER ARM, WHEN STARTED TO DEPLOY THE STENT USING THE LARGE PINWHEEL, THE PINWHEEL BECAME STUCK AND THE STENT ALLEGEDLY STOPPED DEPLOYMENT ABOUT HALF WAY. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED OF APPROXIMATELY 10-20MM. REPORTEDLY, THE STENT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17048696 ↗
• InjuryOct 10, 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 ONE YEAR ELEVEN MONTHS AND TWENTY-TWO DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 70% OF TARGET LESION STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS IS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 15568639 ↗
• MalfunctionJun 16, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DEPLOYED INCORRECTLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14710642 ↗
• InjurySep 9, 2021Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT DEVELOPED 80% OF TARGET LESION STENOSIS AND COMPRESSION AT THE APEX OF THE STENT. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION AND THE STENT COMPRESSION WAS RECOVERED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 12445330 ↗
• InjuryJun 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, POST DEVICE IMPLANTATION SPASM OF OUTFLOW VEIN WAS REPORTED. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 11997695 ↗
• InjuryOct 16, 2020Adverse 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 DURING POST-DILATION OF THE VASCULAR COVERED STENT, SPASM OF THE OUTFLOW VEIN OCCURRED AND WAS RESOLVED WITH PTA. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Device Overstimulation of Tissue; Restenosis

  MAUDE report 10691973 ↗