Orsiro 4.0/13/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07640130438958), received between Apr 15, 2019 and Feb 8, 2022 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. A FIRST STENT WAS IMPLANTED. SUBSEQUENTLY, THE ORSIRO WAS ADVANCED. INSIDE THE ALREADY IMPLANTED STENT THE ORSIRO STENT SLID OFF THE TOP OF THE BALLOON AND WAS SLIGHTLY DISPLACED IN DISTAL DIRECTION, BUT COULD FINALLY BE IMPLANTED AT THE INTENDED TARGET LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13480838 ↗
• MalfunctionApr 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT DISLODGED PRIOR TO PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11741471 ↗
• MalfunctionApr 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID RCA. DURING ATTEMPT TO ADVANCE THE DEVICE TO THE TARGET LESION, THE FIRST BEND PROXIMAL TO THE LESION COULD NOT BE PASSED. AFTER WITHDRAWAL IT WAS NOTICED THAT THE STENT WAS DISLODGED. THE STENT WAS ADAPTED TO THE VESSEL WALL WITH A BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11713014 ↗
• MalfunctionJan 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE STENT WAS DEPLOYED IN THE OSTIUM OF THE RCA WITH APPROXIMATELY TWO-THIRDS OF THE STENT LOCATED IN THE AORTA OUTSIDE THE RCA WHICH WAS UNSATISFACTORY. AN ATTEMPT WAS MADE WITH GUIDE AND SNARE TO REMOVE THE STENT. ON MANIPULATION THE STENT WAS NOTED TO BE DISLODGED FROM THE RCA AND COULD NOT BE LOCATED ANYMORE.

  Patient problems: Insufficient Information

  MAUDE report 11113471 ↗
• MalfunctionJul 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING UNPACKING THE STENT DISLODGED FROM THE BALLOON OUTSIDE FROM THE PATIENTS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10340016 ↗
• MalfunctionJul 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF THE LAD/LM. THE DEVICE GOT CAUGHT IN A PREVIOUS IMPLANTED STENT AND THE ORSIRO STENT DISLODGED. THE STENT COULD NOT BE RETRIEVED AND WAS ADAPTED TO THE VESSEL WALL IN LM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10255673 ↗
• MalfunctionApr 15, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION AT A BIFURCATION LMT/LAD. WHILE ADVANCING THE DEVICE THROUGH THE GUIDING CATHETER, THERE WAS AN ABNORMALITY DETECTED. AFTER REMOVAL OF THE DEVICE IT WAS NOTED THAT THE STENT WAS DEFORMED AT THE DISTAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9962340 ↗
• MalfunctionMar 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS RCA. THE PRE-DILATED LESION COULD NOT BE CROSSED WITH THE DEVICE. DURING WITHDRAWAL THE STENT DISLODGED AND COULD NOT BE RETRIEVED. THE STENT WAS FINALLY OVER-STENTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9838858 ↗
• MalfunctionJan 20, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. PRIOR TO USE IT WAS DETECTED THAT THE STENT WAS DEFORMED AT THE DISTAL PART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9607196 ↗
• MalfunctionNov 13, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION IN A SEVERELY TORTUOUS VESSEL. DESPITE PRE-DILATATION THE LESION COULD NOT BE CROSSED WITH THE DEVICE. AFTER REMOVAL THE STENT DISLODGED OUTSIDE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9315203 ↗
• MalfunctionSep 27, 2019Material Deformation; Material Deformation

  THE ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING THE ATTEMPT TO CROSS THE CALCIFIED LESION IN THE RCA THE ORSIRO COULD NOT PASS AND WAS THEREFORE REMOVED. UPON REMOVAL A STENT DEFORMATION AT THE DISTAL END WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9131995 ↗
• MalfunctionJul 1, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A TORTUOUS RCA. THE DEVICE COULD NOT CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8751248 ↗
• MalfunctionApr 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING PREPARATION IT WAS NOTICED THAT THERE WAS NO STENT ON THE BALLOON. IT WAS FOUND OUTSIDE THE PATIENT INSIDE THE COVER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8515139 ↗