COVERA AVSM07100Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741106262), received between Oct 16, 2019 and Feb 7, 2023 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Premature Activation; Malposition of Device; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE VIA DISTAL ACCESS TO TREAT THROMBOSED ARTERIOVENOUS GRAFT, THE STENT GRAFT ALLEGEDLY JUMPED SEVERAL CENTIMETER FORWARD WHICH RESULTED IN MALPOSITION OF DEVICE DURING DEPLOYMENT AND FAILED. IT WAS FURTHER REPORTED THAT, THE SECOND STENT WAS PLACED TO OVERLAP THE FIRST STENT GRAFT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316153 ↗
• MalfunctionJun 15, 2022Loss of or Failure to Bond; Break; Misfire; Loss of or Failure to Bond; Break; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT, THE DEVICE ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE DEPLOYMENT SYSTEM BROKE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692402 ↗
• MalfunctionJun 15, 2022Loss of or Failure to Bond; Break; Misfire; Detachment of Device or Device Component; Material Deformation; Loss of or Failure to Bond; Break; Misfire; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT, THE DEVICE ALLEGEDLY PARTIALLY DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692374 ↗
• InjuryMar 12, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL APPROXIMATELY 8-MONTHS POST INDEX PROCEDURE, 50% TARGET LESION STENOSIS AND STANDARD PTA WAS PERFORMED TO TREAT LESION. IT WAS FURTHER REPORTED APPROXIMATELY 1 YEAR 11-MONTH POST INDEX PROCEDURE 70% STENOSIS WAS IDENTIFIED AND STANDARD PTA WAS PERFORMED TO TREAT LESION.

  Patient problems: Stenosis

  MAUDE report 9824446 ↗
• MalfunctionJan 13, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM07100 VASCULAR COVERED STENT EXPERIENCED FAILURE TO EXPAND. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583847 ↗
• InjuryOct 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT SOME TIME POST STENT GRAFT PLACEMENT THE STENT GRAFT ALLEGEDLY FRACTURED AND A PSEUDO ANEURYSM WAS IDENTIFIED. REPORTEDLY, THE PATIENT ALLEGEDLY DEVELOPED COMPARTMENT SYNDROME AND A FASCIOTOMY AND STENT REPAIR WERE PERFORMED. THERE WAS NO REPORTED PATIENT INJURY POST STENT GRAFT REPAIR PROCEDURE.

  Patient problems: Injury

  MAUDE report 9200239 ↗