COVERA AVSM07080Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741106255), received between Jul 14, 2020 and Oct 8, 2024 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 8, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT UPPER EXTREMITY ARTERIOVENOUS GRAFT STENOSIS VIA RIGHT UPPER ARM, THE STENT ALLEGEDLY JUMPED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20394996 ↗
• MalfunctionJul 22, 2024Loss of or Failure to Bond; Positioning Failure; Misfire; Loss of or Failure to Bond; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT ARM FISTULA GRAFT, THE DEVICE ALLEGEDLY HAD DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19792330 ↗
• MalfunctionMay 27, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT DURING THE PREPARATION OF A STENT PLACEMENT PROCEDURE, THE INNER BOX ALLEGEDLY HAD A HOLE IN IT. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17015403 ↗
• MalfunctionNov 1, 2022Break; Positioning Failure; Misfire; Break; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN RIGHT THIGH GRAFT, THE CABLE ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THAT 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 15706379 ↗
• InjuryFeb 23, 2022Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY THREE MONTHS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED SEVENTY PERCENT OF TARGET LESION STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THEN, APPROXIMATELY SIX MONTHS AND FIFTEEN DAYS POST INDEX PROCEDURE, THROMBOSIS WAS DIAGNOSED. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND THROMBECTOMY/THROMBOLYSIS WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS IS NOT PROVIDED.

  Patient problems: Restenosis; Thrombosis/Thrombus

  MAUDE report 13583069 ↗
• MalfunctionSep 30, 2021Loss of or Failure to Bond; Break; Positioning Failure; Loss of or Failure to Bond; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. THE DEVICE WAS REMOVED AND THE STENT WAS TRIED TO BE DEPLOYED MANUALLY BUT THE STRING INSIDE THE SYSTEM WAS NOT FOUND TO BE ATTACHED TO THE HANDLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12555238 ↗
• MalfunctionJul 14, 2020Malposition of Device; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL AVSM07080 VASCULAR COVERED STENT WAS ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) MALE PATIENT WAS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271441 ↗
• MalfunctionJul 14, 2020Material Deformation; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM07080 VASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271440 ↗