COVERA AVSM10100Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00801741106415), received between Mar 11, 2019 and Sep 3, 2025 — classified as 5 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Misfire” (4 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 3, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE. DURING THE STENT PLACEMENT PROCEDURE, IT WAS REPORTED THAT THE DISTAL END OF THE DEPLOYED STENT ALLEGEDLY FAILED TO EXPAND WITHOUT BALLOON ASSISTANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22949790 ↗
• 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 ONE YEAR AND TWELVE DAYS POST A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT IN THE CEPHALIC VEIN AT CEPHALIC VEIN ARCH VIA THE RIGHT UPPER ARM ACCESS, THE SUBJECT HAD CEPHALIC VEIN RESTENOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION DUE TO PULSATILITY AND ABNORMAL PHYSICAL EXAMINATION. STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT PULSATILITY AND ABNORMAL PHYSICAL EXAMINATION. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME WAS RECOVERED. IT WAS FURTHER REPORTED THAT ONE YEAR, SIX MONTHS, AND TWENTY-SEVEN DAYS POST A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT, THE SUBJECT HAD CEPHALIC VEIN RESTENOSIS WHICH REQUIRED AN ARTERIOVENOUS ACCESS CIRCUIT RE-INTERVENTION DUE TO PULSATILITY AND ANEURYSM. STANDARD PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY PROCEDURE WAS PERFORMED TO TREAT PULSATILITY AND ANEURYSM. TREATMENT RE-INTERVENTION WAS SUCCESSFUL, NO NEW ACCESS CREATED, AND THE OUTCOME WAS RECOVERED. IT WAS ALSO REPORTED THAT TWO YEARS AND TWENTY-EIGHT DAYS POST A VASCULAR COVERED STRAIGHT STENT GRAFT PLACEMENT, THE S

  Patient problems: Restenosis

  MAUDE report 19104522 ↗
• MalfunctionApr 20, 2023Loss of or Failure to Bond; Positioning Failure; Loss of or Failure to Bond; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN RIGHT UPPER CEPHALIC VEIN FOR IN-STENT STENOSIS, THE DEPLOYMENT WHEEL ALLEGEDLY BECAME LOOSE AND FAILED TO DEPLOY THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16774107 ↗
• MalfunctionJan 19, 2023Break; Misfire; Break; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16202107 ↗
• MalfunctionJul 30, 2022Loss of or Failure to Bond; Positioning Failure; Misfire; Loss of or Failure to Bond; Positioning Failure; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136696 ↗
• MalfunctionMay 20, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE UPPER ARM FISTULA, ALLEGEDLY RESISTANCE WAS FELT AT THE BEGINNING AND AFTER DEPLOYING A CERTAIN LENGTH, THE DEPLOYMENT WHEEL TURNED WITHOUT FURTHER COVERED STENT DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460964 ↗
• InjuryApr 5, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH THE RESULTS OF A CLINICAL TRIAL, THAT APPROXIMATELY FIVE MONTHS AND TWENTY SIX DAYS POST INDEX PROCEDURE, THE PATIENT DEVELOPED SEVENTY PERCENTAGE OF TARGET LESION STENOSIS AND OBSTRUCTION OF FLOW WAS NOTED. A STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Restenosis

  MAUDE report 14010661 ↗
• InjuryFeb 22, 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, RESTENOSIS 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: Ischemia; Pain; Restenosis

  MAUDE report 13576905 ↗
• InjuryDec 1, 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 FOUR MONTHS POST INDEX PROCEDURE, THE SUBJECT DEVELOPED 70% OF NON-TARGET LESION STENOSIS NOT TREATED AT INDEX PROCEDURE. STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS USED TO SUCCESSFULLY TREAT THE NON-TARGET LESION. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Restenosis; Thrombosis/Thrombus

  MAUDE report 12906359 ↗
• InjuryAug 24, 2021Obstruction of Flow; Material Deformation; Obstruction of Flow; Material Deformation

  IT WAS REPORTED THAT ONE WEEK POST STENT GRAFT PLACEMENT, THE PATIENT ALLEGEDLY EXPERIENCED ARM SWELLING. THEREFORE AN ULTRASOUND WAS PERFORMED AND IDENTIFIED THAT THE STENT WAS COMPRESSED AND THE FLOW WAS DIMINISHED WHICH CAUSED THE ARM SWELLING. THE PROCEDURE WAS COMPLETED BY PLACING ANOTHER STENT INSIDE THE EXISTING STENT. THE PATIENT'S CURRENT STATUS WAS UNKNOWN.

  Patient problems: Obstruction/Occlusion; Swelling/ Edema

  MAUDE report 12359060 ↗
• MalfunctionJul 14, 2020Break; Positioning Failure; Break; Positioning Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM10100 COVERA VASCULAR COVERED STENT SYSTEM ALLEGEDLY EXPERIENCED BROKEN SHEATH AND FAILED TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6) YEARS OLD AND WEIGHS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10271736 ↗
• MalfunctionJul 22, 2019Difficult or Delayed Positioning; Activation Failure; Difficult or Delayed Positioning; Activation Failure

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL AVSM10100 VASCULAR COVERED STENT ALLEGEDLY WAS DIFFICULT TO DEPLOY AND FAILED TO EXPAND. A BALLOON WAS USED TO POST DILATE AND ANOTHER STENT GRAFT WAS DEPLOYED TO COVER THE LESION. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8812545 ↗
• MalfunctionMar 11, 2019Break; Misfire; Break; Misfire

  IT WAS REPORTED THAT DURING THE STENT GRAFT PLACEMENT VIA THE CEPHALIC VEIN, THE DELIVERY SYSTEM ALLEGEDLY DEPLOYED ONE CENTIMETER. FURTHERMORE, THE HEALTHCARE PROVIDER CONTINUED TO ROLL BACK THE DEPLOYMENT WHEEL WITHOUT SUCCESS, SO THE DELIVERY SYSTEM WAS RETRACTED. REPORTEDLY, A NEW DELIVERY SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8409945 ↗