Orsiro 3.0/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07640130439054), received between Aug 21, 2019 and Jan 27, 2022 — classified as 1 death, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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 16, 2026.

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.

• MalfunctionJan 27, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ORSIRO STENT COULD NOT CROSS THE LESION AND WAS REPORTED TO BE FRAYED AT ITS END AFTER REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367488 ↗
• MalfunctionSep 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE RCA. THE STENT WAS DISLODGED AS IT WAS LOADED ONTO THE WIRE PRIOR TO ENTERING INTO PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12406801 ↗
• MalfunctionJul 28, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT CATHETER WAS BEING INTRODUCED AND DISLODGED AT THE HUB OF THE SHEATH, RIGHT AT THE EXTERIOR POINT OF THE SHEATH. IT WAS NOTICED THAT STRUTS WERE FLARED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12236392 ↗
• MalfunctionSep 9, 2020Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A DISTAL MODERATELY TORTUOUS RCA. THE DEVICE WOULD NOT CROSS PRIOR STENT. REPEATED ATTEMPTS RESULTED IN THE DISENGAGEMENT OF THE GUIDE CATHETER AND WITHDRAWAL OF THE CORONARY GUIDEWIRE INTO THE AORTIC ROOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10511692 ↗
• MalfunctionMar 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO US DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING REMOVAL OF THE PROTECTOR SHEATH THE STENT DISLODGED OUTSIDE PATIENT AND WAS NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878270 ↗
• MalfunctionMar 6, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUING STENT SYSTEM WAS SELECTED FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE RCA. WHILE IT WAS INSERTED INTO THE LESION THE STENT DISLODGED FROM THE BALLOON. IT WAS ATTEMPTED TO RETRIEVE THE DISLODGED STENT WITH A SNARE BUT THIS WAS UNSUCCESSFUL AND IT REMAINED INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9800582 ↗
• MalfunctionJan 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN A MODERATE TORTUOUS RCA. AFTER DEVICE INTRODUCTION INTO THE TARGET LESION, IT WAS NOTICED THAT THERE WAS NO STENT ON THE BALLOON. THE STENT WAS FOUND NEITHER OUTSIDE NOR INSIDE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9566184 ↗
• DeathDec 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS IMPLANTED IN A STEMI PATIENT WITH A TOTAL OCCLUSION OF THE RCA. A T.V.P. (TRANSVENOUS PACING) WAS PLACED DUE TO ARRHYTHMIA EPISODES PRIOR TO PROCEDURE. THE PATIENT HAD SEVERAL ARRHYTHMIA EPISODES DURING THE INTERVENTION. ANGIOGRAPHIC FILMS SHOWED THAT POST-PROCEDURE THE STENT WAS OPEN AND THE ARTERY HAD GOOD BLOOD FLOW. APPROXIMATELY 1 HOUR POST-PROCEDURE, THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA (VT) AND WAS NOT ABLE TO BE RESUSCITATED. PRELIMINARY FINDINGS INDICATED THAT THE ADVERSE EVENT WAS NOT STENT RELATED. THE CIRCUMSTANCES OF DEATH ARE STILL UNCLEAR. AN AUTOPSY WAS ORDERED, HOWEVER NO RESULTS HAVE BEEN REPORTED. NO LOT NUMBER WAS PROVIDED.

  Patient problems: Death

  MAUDE report 9438598 ↗
• MalfunctionOct 8, 2019Difficult to Remove; Difficult to Remove

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING THE PROCEDURE THE STENT GOT CAUGHT ON THE WIRE. THEREFORE, THE WIRE COULD HARDLY BE REMOVED. NO HARM TO PATIENT HAD OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167909 ↗
• MalfunctionAug 28, 2019Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (>90 PERCENT STENOSIS DEGREE) IN A TORTUOUS PART OF THE RCA. THE DEVICE COULD NOT BE ADVANCED. AFTER WITHDRAWAL IT WAS DETECTED THAT BOTH STENTS WERE DAMAGED. A TELEFLEX 6F GUIDELINER WAS USED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940740 ↗
• MalfunctionAug 28, 2019Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (>90 PERCENT STENOSIS DEGREE) IN A TORTUOUS PART OF THE RCA. THE DEVICE COULD NOT BE ADVANCED. AFTER WITHDRAWAL IT WAS DETECTED THAT THE STENT WAS DAMAGED. A TELEFLEX 6F GUIDELINER WAS USED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8940731 ↗
• MalfunctionAug 26, 2019Difficult to Remove; Difficult to Remove

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A STENOSIS (100 PERCENT STENOSIS DEGREE) IN THE PROXIMAL LAD. AFTER PRE-DILATATION THE STENT WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE DEVICE RESISTANCE WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932820 ↗
• MalfunctionAug 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED AND TORTUOUS LESION IN THE MEDIAL RCA. THE TARGET LESION COULD NOT BE CROSSED AND DURING WITHDRAWAL THE STENT DISLODGED FROM THE BALLOON.

  Patient problems: Foreign Body In Patient

  MAUDE report 8932818 ↗
• MalfunctionAug 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING PREPARATION THE ORSIRO STENT DISLODGED FROM THE BALLOON OUTSIDE THE PATIENT. THE DEVICE WAS NEVER USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915890 ↗