COVERA AVSM09100Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741106361), received between Oct 20, 2021 and May 16, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Misfire” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 16, 2025Material Deformation; Material Deformation

  ON, (B)(6) 2025 , A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT IN RECURRENT STENOSIS VENOUS ANASTOMOSIS INTO THE BASILIC VEIN. DURING THE PROCEDURE, THE STENT DEPLOYED IN LEFT ARM. PHYSICIAN STATED THAT THE DISTAL ENDS OF THE STENT ARE FOLDED IN. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22034289 ↗
• MalfunctionDec 3, 2024Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE DISTAL PORTION OF THE DEVICE APPEARED BUNCHED UP. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20829296 ↗
• MalfunctionJun 10, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE ARRIVED WITH WATER DAMAGE. IT WAS FURTHER REPORTED THAT THERE WAS WATER DAMAGE TO THE INNER PACKAGING AND THE DEVICE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495993 ↗
• MalfunctionJun 10, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE ARRIVED WITH WATER DAMAGE. IT WAS FURTHER REPORTED THAT THERE WAS WATER DAMAGE TO THE INNER PACKAGING AND THE DEVICE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495990 ↗
• MalfunctionJun 10, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE ARRIVED WITH WATER DAMAGE. IT WAS FURTHER REPORTED THAT THERE WAS WATER DAMAGE TO THE INNER PACKAGING AND THE DEVICE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495989 ↗
• MalfunctionMar 26, 2024Fracture; Material Puncture/Hole; Fracture; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT CEPHALIC VEIN AT CEPHALIC ARCH VIA THE DISTAL CEPHALIC VEIN, THE STENT ALLEGEDLY RUPTURED. IT WAS FURTHER REPORTED THAT ADDITIONAL STENT WAS PLACED INSIDE THE RUPTURED STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18984423 ↗
• MalfunctionAug 8, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY NOT FULLY DEPLOYED AND WAS COMPACTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17479553 ↗
• MalfunctionDec 12, 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, THE STENT ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15957240 ↗
• MalfunctionAug 1, 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, 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 15137456 ↗
• MalfunctionJun 8, 2022Loss of or Failure to Bond; Misfire; Loss of or Failure to Bond; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14630676 ↗
• InjuryOct 20, 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 FOUR MONTHS AND TWENTY SEVEN DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 100% OF TARGET LESION STENOSIS. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE SUBJECT EXPIRED DUE TO SEPTICEMIA, SPINAL INFECTION AND URINARY TRACT INFECTION (UTI) WITH BOWEL BLADDER FISTULA AND THE CAUSE OF DEATH WAS NOT RELATED TO THE DEVICE, NOT RELATED TO PROCEDURE AND NOT RELATED TO ARTERIOVENOUS (AV) ACCESS CIRCUIT.

  Patient problems: Restenosis

  MAUDE report 12666320 ↗