ELUVIA™ H74939294701010Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729876724), received between Sep 27, 2019 and Oct 19, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2023Fracture; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Difficult to Advance; Material Integrity Problem; Fracture; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT AND FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). A 7X100, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR A LEFT LEG INTERVENTION. PEDAL ACCESS, AND ANGIOGRAM WAS PERFORMED. LASER ATHERECTOMY OF THE SFA/POPLITEAL (POP)/AT VESSELS. BALLOON ANGIOPLASTY WAS PERFORMED POST ATHERECTOMY. A PERFORATED SEGMENT IN THE DISTAL POPLITEAL ARTERY WITH ANGIOGRAPHIC EVIDENCE WAS NOTED. THE ELUVIA STENT WAS PLACED OVER THE 014 NON-BOSTON SCIENTIFIC GUIDEWIRE TO BE DEPLOYED IN THE PROXIMAL SFA. THE PHYSICIAN HAD TROUBLE ADVANCING THE DEVICE TO THE LESION LOCATION IN THE DISTAL SFA/POP LOCATION. THE ENTIRE SEGMENT FROM TPT-COMMON FEMORAL ARTERY (CFA) WAS STENTED PREVIOUSLY WITH IN-STENT RESTENOSIS (ISR) EFFECTING THE ENTIRE LENGTH. WHEN THE DEVICE COULD NOT BE ADVANCED TO THAT AREA FOR IMPLANTATION, THE PHYSICIAN DECIDED TO DEPLOY THE STENT IN THE AREA OF PERFORATION, POPLITEAL ARTERY. THE PHYSICIAN WAS ADVANCING THE STENT, TO THE PRIMARY SFA LESION LOCATION, AGGRESSIVELY AND THE STENT SHAFT WAS

  Patient problems: Discomfort; Hematoma; Pain; Swelling/ Edema

  MAUDE report 17966964 ↗
• MalfunctionDec 21, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT ONE CORNER OF THE STERILE PACKAGING WAS NOT COMPLETELY SEALED. DURING DEVICE PREPARATION FOR THE ANGIOGRAM PROCEDURE, AN ELUVIA US, 7X100, 130 CM WAS SELECTED FOR USE TO TREAT PERIPHERAL ARTERY DISEASE. AS THE DEVICE PACKAGING WAS OPENED, IT WAS OBSERVED THAT ONE CORNER OF THE STERILE PACKAGING WAS NOT PROPERLY SEALED, COMPROMISING THE STERILITY OF THE DEVICE. THE POTENTIALLY CONTAMINATED ELUVIA WAS NOT USED AND WAS DISPOSED OF BY THE STAFF. THE ELUVIA WAS REPLACED IN ORDER TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16030041 ↗
• MalfunctionSep 27, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT GUIDEWIRE AND CATHETER ENTRAPMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A .035 MAGIC TORQUE GUIDEWIRE WAS USED WITH A 7X100, 130CM ELUVIA SELF-EXPANDING STENT. DURING THE PROCEDURE THE GUIDEWIRE BECAME STUCK WITHIN THE STENT DELIVERY SYSTEM AND COULD NOT BE REMOVED. THE MAGIC TORQUE GUIDEWIRE AND THE ELUVIA STENT DELIVERY SYSTEM WERE REMOVED TOGETHER AS ONE UNIT. THE PROCEDURE WAS THEN COMPLETED USING A NEW GUIDEWIRE AND A 7X40MM ELUVIA STENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131412 ↗