COVERA AVSM08080Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741106309), received between Jul 14, 2020 and Aug 5, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Obstruction of Flow” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 5, 2025Misfire; Misfire

  ON (B)(6) 2025, A PATIENT UNDERWENT STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT IN THE RIGHT MEDIAN CUBITAL VEIN VIA FISTULA. DURING THE PROCEDURE, THE STENT PLACED IN THE VESSEL ALLEGEDLY DEPLOYED PARTIALLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22711183 ↗
• MalfunctionFeb 25, 2025Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT WAS FOLDED ON THE DISTAL SIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21456927 ↗
• MalfunctionMar 19, 2024Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE CEPHALIC ARCH VIA THE LEFT BRACHIAL CEPHALIC FISTULA, THE STENT ALLEGEDLY GOT STUCK IN THE SHEATH AFTER IT WAS DEPLOYED. IT WAS FURTHER REPORTED THAT TO GET THE STENT OUT, THE SHEATH WAS REMOVED WITH THE STENT OVER THE WIRE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18928710 ↗
• MalfunctionOct 9, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT TWENTY-ONE DAYS POST STENT GRAFT PLACEMENT, A CORE LAB ANALYSIS WAS PERFORMED FOR THE STENT DETAILS ANALYSIS AND THE CORE LAB IDENTIFIED THAT THE STENT GRAFT ALLEGEDLY HAD A MODERATE KINKING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17894060 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL STUDY THAT APPROXIMATELY, EIGHT MONTHS AND TEN DAYS, POST STENT PLACEMENT PROCEDURE, THE PATIENT DEVELOPED 70 % OF TARGET LESION STENOSIS. STANDARD PTA WAS USED FOR TREATMENT. THE RE-INTERVENTION PROCEDURE WAS SUCCESSFUL, AND NO NEW ACCESS WAS CREATED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 15196769 ↗
• InjuryAug 27, 2021Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY TWO YEARS ONE MONTH 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: Hemorrhage/Blood Loss/Bleeding; Restenosis

  MAUDE report 12375998 ↗
• MalfunctionJul 14, 2020Material Separation; Obstruction of Flow; Material Separation; Obstruction of Flow

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM08080 COVERA VASCULAR COVERED STENT SYSTEM ALLEGEDLY EXPERIENCED A MATERIAL SEPARATION/DISSECTION ON IMAGING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT'S AGE, SEX AND WEIGHT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271735 ↗