COVERA AVSM07040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741106231), received between Jan 10, 2020 and Apr 16, 2024 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionApr 16, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTER THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY JUMPED IT WAS BEING DEPLOYED AND WAS ALLEGEDLY ENDED UP IN THE WRONG SPOT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19113676 ↗
• InjuryJul 30, 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 DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED NON-TARGET LESION STENOSIS. STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE NON-TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

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

  MAUDE report 12251208 ↗
• MalfunctionApr 8, 2020Activation Failure; Activation Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM07040 VASCULAR COVERED STENT ALLEGEDLY EXPERIENCED AN ACTIVATION FAILURE INCLUDING EXPANSION FAILURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941111 ↗
• MalfunctionJan 10, 2020Activation Failure; Activation Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM07040 COVERA VASCULAR COVERED STENT SYSTEM ALLEGEDLY EXPERIENCED FAILURE TO EXPAND. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9578411 ↗