COVERA AVSL06060Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741106644), received between Aug 22, 2022 and May 13, 2024 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ARTERIOVENOUS FISTULA VIA THE LEFT FOREARM, THE STENT ALLEGEDLY COULD NOT CROSS THE LESION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296735 ↗
• DeathAug 22, 2022Loss of or Failure to Bond; Positioning Failure; Retraction Problem; Insufficient Device Problem Information; Loss of or Failure to Bond; Positioning Failure; Retraction Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING TWO STENT GRAFTS PLACEMENT PROCEDURE IN THE COMMON ILIAC ARTERIES, USING THE COVERED ENDOVASCULAR RECONSTRUCTION OF AORTIC BIFURCATION (CERAB) TECHNIQUE, THE FIRST STENT GRAFT WAS SUCCESSFULLY PLACED IN THE COMMON ILIAC; HOWEVER, DURING AN ATTEMPT TO IMPLANT THE SECOND STENT GRAFT, THE HEALTH CARE PROVIDER (HCP) ALLEGEDLY EXPERIENCE RESISTANCE DURING DEPLOYMENT AND DECIDED TO REMOVE THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT AN ALLEGED RETRACTION PROBLEM OCCURRED RESULTING IN THE LOSS OF ACCESS SITE AS THE GUIDEWIRE/SHEATH/DEVICE WERE REMOVED AS A SINGLE UNIT. THE HCP THEN DECIDED TO HALT THE PROCEDURE AND PERFORMED A FEMORAL-FEMORAL BYPASS THE FOLLOWING DAY TO CONCLUDE TREATMENT. REPORTEDLY, THE PATIENT THEN HAD THREE MORE SURGERIES, WAS INTUBATED, APPROXIMATELY THREE DAYS LATER THE PATIENT EXPIRED. THE RELATIONSHIP BETWEEN THE DEVICE RELATED ISSUES AND THE PATIENT IMPACT IS UNKNOWN.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15271852 ↗