COVERA AVFM08100Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741106538), received between Aug 17, 2020 and Sep 15, 2026 — classified as 2 injuries, 2 malfunctions.

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

• MalfunctionSep 15, 2026Material Deformation

  On (b)(6) 2026, a patient underwent a stent placement procedure using a Covera Vascular Covered Stent. It was reported that additional interventions were performed in (b)(6) 2026. During the (b)(6) 2026 procedure, the stent demonstrated evidence of collapse, and balloon angioplasty was performed. On (b)(6) 2026, recurrent collapse of the proximal portion of the stent was observed. The physician performed balloon angioplasty using an 8 × 80 mm Vaccess balloon and subsequently relined the Covera stent with a Wraysody stent. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769778 ↗
• MalfunctionJul 19, 2024Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE BRACHIOCEPHALIC FISTULA, THE STENT ALLEGEDLY CRUNCHED UP. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY DID NOT COVER THE ENTIRE AREA INTENDED. THE PROCEDURE WAS COMPLETED USING SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19781371 ↗
• InjurySep 30, 2020Adverse 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 DURING POST-DILATION OF THE VASCULAR COVERED STENT, SPASM OF THE OUTFLOW VEIN OCCURRED AND WAS RESOLVED WITH PTA. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED THE SAME DAY. THE CURRENT PATIENT STATUS WAS NOT PROVIDED.

  Patient problems: Device Overstimulation of Tissue; Injury; Ischemia

  MAUDE report 10605778 ↗
• InjuryAug 17, 2020Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST STENT PLACEMENT THROUGH CEPHALIC ARCH, THE HEALTH CARE PROVIDER IDENTIFIED UNDER IMAGING AN ALLEGED STENT COMPRESSION. IT WAS FURTHER REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE TO TREAT THE NARROWING. THE PATIENT WAS STABLE POST ADDITIONAL BALLOON DILATATION.

  Patient problems: Pain

  MAUDE report 10412370 ↗