COVERA AVSM07060Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741106248), received between Jul 11, 2019 and Aug 8, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2024Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY WOULD NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19937030 ↗
• MalfunctionMar 15, 2021Positioning Failure; Retraction Problem; Positioning Failure; Retraction Problem

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT 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 11481156 ↗
• MalfunctionJul 15, 2020Positioning Failure; Failure to Advance; Positioning Problem; Positioning Failure; Failure to Advance; Positioning Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM07060 VASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE, FAILURE TO ADVANCE, AND POSITIONING PROBLEM. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT¿S AGE, WEIGHT, AND SEX WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10277225 ↗
• MalfunctionJul 15, 2020Break; Retraction Problem; Break; Retraction Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM07060 VASCULAR COVERED STENT SYSTEM ALLEGEDLY EXPERIENCED BREAK AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD PATIENT INVOLVEMENT BUT THE PATIENT HAD NO CONSEQUENCES. THE AGE AND WEIGHT OF THE MALE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276469 ↗
• MalfunctionJul 14, 2020Misfire; Malposition of Device; Misfire; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM07060 COVERA VASCULAR COVERED STENT ALLEGEDLY EXPERIENCED MALPOSITION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) MALE IS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271344 ↗
• MalfunctionJul 11, 2019Malposition of Device; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM07060. VASCULAR COVERED STENT ALLEGEDLY EXPERIENCED MALPOSITION OF DEVICE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6) YEARS OF AGE, THE GENDER IS MALE, AND THE WEIGHT IS (B)(6) KGS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8783337 ↗