COVERA AVSM09040Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741106330), received between May 12, 2021 and Apr 7, 2023 — classified as 8 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH RESULTS OF A CLINICAL TRIAL THAT ONE YEAR NINE MONTHS AND TWENTY-FOUR DAYS POST INDEX PROCEDURE, THE TARGET LESION AT CEPHALIC VEIN HAD A MAXIMUM INITIAL STENOSIS OF SIXTY PERCENT. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE PATIENT RECOVERED WITH FINAL RESIDUAL STENOSIS OF ZERO PERCENT. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 16698990 ↗
• InjuryNov 29, 2022Adverse 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 ONE YEAR EIGHT MONTHS AND TWENTY SIX DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED SIXTY PERCENT OF STENOSIS. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS IS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 15875437 ↗
• InjuryMar 21, 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 NINE MONTHS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED AND STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT STATUS OF THE SUBJECT IS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 13837783 ↗
• InjuryMar 2, 2022Adverse 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 SEVEN MONTHS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED AND STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT STATUS OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: Stenosis

  MAUDE report 13647406 ↗
• MalfunctionNov 19, 2021Loss of or Failure to Bond; Break; Misfire; Loss of or Failure to Bond; Break; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH THE RIGHT COMMON FEMORAL VEIN AND THE RIGHT BASILIC VEIN TO TREAT SUBCLAVIAN VEIN OCCLUSION, THE STRING OF THE DEVICE ALLEGEDLY BROKE DURING DEPLOYMENT AND THE STENT HAD PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12843450 ↗
• InjuryMay 26, 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 THREE MONTHS AND THREE DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 50 % OF TARGET LESION STENOSIS. STANDARD PTA AND BARE METAL STENT WERE USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 11883175 ↗
• InjuryMay 26, 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 MONTHS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 60 % OF TARGET LESION STENOSIS. STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 11883159 ↗
• InjuryMay 26, 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 THREE MONTHS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 50 % OF TARGET LESION STENOSIS. STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 11883141 ↗
• InjuryMay 26, 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 THREE MONTHS AND THIRTEEN DAYS POST INDEX PROCEDURE, STENOSIS IN TARGET LESION WAS OBSERVED. STANDARD PTA AND BARE METAL STENT WERE USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 11883102 ↗
• MalfunctionMay 12, 2021Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH THE LEFT BRACHIAL VEIN TO TREAT CHRONIC STENOSIS, THE STENT ALLEGEDLY MALPOSITIONED AND WAS DELIVERED INACCURATELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11811262 ↗