COVERA AVSM09080Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741106354), received between Jan 13, 2020 and Aug 18, 2025 — classified as 1 death, 4 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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. 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2025Device Damaged Prior to Receipt by User; Device Damaged Prior to Receipt by User

  A PATIENT PREPPED FOR A STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT. PRIOR TO THE PROCEDURE IT WAS FOUND THAT, THE DEVICE WAS ALLEGEDLY BENT IN HALF AND PACKAGING ISSUE WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22824883 ↗
• MalfunctionJul 9, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT A 9X80 MM STENT WAS FOUND COLLAPSED ABOUT FOUR MONTHS AFTER PLACEMENT. THE 9X80 MM STENT HAD BEEN PLACED IN (B)(6) 2024 DUE TO A RUPTURE OF THE CEPHALIC ARCH AREA AND AN ELASTIC RECOIL OF A STENOSIS AFTER ANGIOPLASTY WITH AN 8X100 MM BALLOON TO TREAT A TIGHT RECURRENT STENOSIS IN THE CEPHALIC ARCH. JUST AFTER PLACEMENT OF THE STENT, THE CEPHALIC VEIN OF THE UPPER ARM BELOW THE CEPHALIC ARCH LOOKED STENOTIC, EVEN THOUGH IT HAD A GOOD SIZE PRIOR TO STENT PLACEMENT. POST DILATION DID NOT IMPROVE THE SITUATION. HOWEVER, THE VESSEL HAD A GOOD THRILL AND SOFT NORMAL PULSATION. FOUR MONTHS AFTER STENT PLACEMENT, THE PATIENT WAS SEEN DUE TO PROLONGED BLEEDING; THE 9X80 MM STENT WAS FOUND COLLAPSED AND THERE WAS NO FLOW THROUGH THE STENT. INITIALLY, THE PHYSICIAN WAS NOT ABLE TO PASS A GUIDE WIRE THROUGH THE STENT; AFTER PROLONGED MANIPULATION, A GUIDE WIRE COULD BE ADVANCED THROUGH THE STENT AND AN ADDITIONAL STENT, A 12X40 MM STENT OF A DIFFERENT BRAND, WAS PLACED WITHIN THE COLLAPSED 9X80 MM STENT. ANOTHER SEVEN WEEKS LATER, THE AREA OF THE 9X80 MM STENT, WHICH WAS NOT EXPANDED BY THE 12X40 MM STENT, WAS FOUND COMPRESSED AS WELL. AN ADDITIONAL 13X100 MM STENT OF ANOT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22456870 ↗
• MalfunctionJun 3, 2025Material Deformation; Material Deformation

  ON 8 MAY 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE COVERA VASCULAR COVERED STENT IN THE THROMBOSIS OF THE LEFT ARM BASILIC VEIN. UPON DEPLOYMENT OF THE COVERA, A NOTICEABLE CLICK WAS HEARD DURING DEPLOYMENT, CAUSING THE STENT TO JUMP CENTRALLY ABOUT A MILLIMETER OR TWO. ONCE DEPLOYED, THE STENT WAS POST DIALATED WITH THE SAME 9X40 BIOTRONIK PASEO BALLOON. AFTER CHECKING WITH FLUORO, THE PHYSICIAN DECIDED TO ULTRASOUND THE STENTED SEGMENTED, AND IT WAS THEN NOTICED THAT THE STENT HAS COLLAPSED, INTRASTENT PROXIMALLY TO THE END OF THE NEWLY PLACED COVERA. THE PHYSICIAN CHECKED THE THRILL AND NOTICED THE ACCESS FEELING PULSATILE. SHE WENT BACK TO ANGIOPLASTY THAT AFFECTED AREA WITH THE SAME 9X40 BIOTRONIK PASEO BALLOON TO OPEN THE COLLAPSED AREA. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22130494 ↗
• MalfunctionAug 21, 2024Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY SOMETIME POST STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY COMPRESSED AFTER IT WAS DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT WAS FRACTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010611 ↗
• InjuryApr 15, 2024Adverse 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 TWO YEARS, FIVE MONTHS AND THIRTEEN DAYS POST A STENT GRAFT PLACEMENT IN THE CEPHALIC VEIN AT CEPHALIC VEIN ARCH VIA THE LEFT UPPER ARM, THE SUBJECT DEVELOPED CEPHALIC VEIN RESTENOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION DUE TO PULSATILITY AND ANEURYSMATIC FISTULA. IT WAS FURTHER REPORTED THAT STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT PULSATILITY AND ANEURYSMATIC FISTULA. TREATMENT REINTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED AND THE OUTCOME OF ARTERIOVENOUS ACCESS CIRCUIT REINTERVENTION WAS RESOLVED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Restenosis

  MAUDE report 19104511 ↗
• MalfunctionDec 18, 2023Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18343156 ↗
• MalfunctionJun 15, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY DID NOT OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17133075 ↗
• InjuryDec 10, 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 AND FOUR DAYS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED SEVENTY 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 15956042 ↗
• MalfunctionJan 9, 2022Loss of or Failure to Bond; Misfire; Loss of or Failure to Bond; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13201029 ↗
• InjuryNov 8, 2021Migration or Expulsion of Device; Obstruction of Flow; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Obstruction of Flow; Material Twisted/Bent; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY FORTY FIVE DAYS POST INDEX PROCEDURE, THE PATIENT DEVELOPED SEVENTY PERCENTAGE OF TARGET LESION STENOSIS. A STANDARD PTA WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Aneurysm; Restenosis; Unspecified Tissue Injury

  MAUDE report 12769791 ↗
• DeathOct 5, 2021Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY THREE MONTHS POST INDEX PROCEDURE, THE PATIENT WAS EXPIRED. THE DEATH WAS NOT RELATED TO THE STUDY DEVICE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12574069 ↗
• InjuryFeb 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT APPROXIMATELY THREE MONTHS POST STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FOLDED COMPLETELY ON ONE END. IT WAS FURTHER REPORTED THAT A PIECE OF GRAFT WAS SUTURED FROM VEIN TO THE STENT TO REPAIR THE FISTULA. THE PATIENT CURRENT STATUS WAS UNKNOWN.

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

  MAUDE report 11320479 ↗
• MalfunctionJan 18, 2021Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11184352 ↗
• MalfunctionJan 13, 2020Material Deformation; Activation Failure; Material Deformation; Activation Failure

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL AVSM09080 VASCULAR COVERED STENT ALLEGEDLY FAILED TO EXPAND. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583526 ↗