Orsiro 2.5/9/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130438859), received between Apr 15, 2019 and Jan 4, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING AN EXTREMELY DIFFICULT AND COMPLEX TREATMENT OF THE PROXIMAL CX, THE STENT DISLODGED AND WAS NOT FOUND. IT IS PRESUMED THAT THE STENT REMAINED IN PATIENT, CRUSHED WITHIN THE STENTED PORTION OF THE PROXIMAL CX DURING POST DILATATIONS. 6F AND 7F GUIDELINER V3 CATHETERS WERE USED DURING PROCEDURE. FOLLOW-UP IMAGING SHOWED 0 PERCENT RESIDUAL STENOSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16096189 ↗
• MalfunctionJul 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE 2ND DIAGONAL. THE DELIVERY SYSTEM ADVANCED ACROSS THE LESION, BUT AFTER DEPLOYMENT ATTEMPT, STENT WAS UNABLE TO BE VISUALIZED. IT WAS REPORTED THAT THE UNDEPLOYED STENT WAS ULTIMATELY RETRIEVED USING AN NC BALLOON AND PULLED INTO THE GUIDE CATHETER TO BE REMOVED FROM THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243038 ↗
• MalfunctionOct 27, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. DURING LESION CROSSING THE ORSIRO STENT COULD NOT PASS THE LESION AND IT WAS DECIDED TO REMOVE IT. AFTER WITHDRAWAL THE STENT DISLODGED FROM THE BALLOON OUTSIDE THE PATIENTS BODY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10741574 ↗
• MalfunctionMar 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE OSTIAL OM. THE DEVICE COULD NOT BE DELIVERED TO THE TARGET LESION. THE STENT DISLODGED AND MIGRATED. THE STENT WAS ADAPTED TO THE VESSEL WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812180 ↗
• MalfunctionOct 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2019 IT WAS INTENDED TO PLACE THE ORSIRO DRUG-ELUTING STENT IN THE DISTAL RCA. ON THE NEXT DAY IT WAS NOTICED THAT THE STENT HAD DISLODGED FROM THE BALLOON PRIOR TO DEPLOYMENT AND ONLY A POBA WAS PERFORMED. EVENTUALLY THE STENT MIGRATED TO THE PLV AND REMAINED IN THE PATIENTS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9158975 ↗
• MalfunctionJul 18, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN A PROXIMAL TORTUOUS CX. DESPITE SEVERAL PREDILATATIONS THE DEVICE COULD NOT CROSS THE LESION. A 7F GUIDEZILLA EXTENSION CATHETER WAS USED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802301 ↗
• MalfunctionMay 27, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT WAS SELECTED TO TREAT A SEVERELY CALCIFIED LESION IN A TORTUOUS DISTAL LAD. DESPITE PRE-DILATATION THE DEVICE COULD NOT CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8644262 ↗
• MalfunctionApr 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT WAS POSITIONED IN THE CALCIFIED AND TORTUROUS MEDIAL CX. AFTER BALLOON INFLATION IT WAS NOT CLEAR WHETHER THE ORSIRO STENT WAS DEPLOYED. THEREFORE THE DEVICE WAS WITHDRAWN AND OUTSIDE OF THE PATIENT IT WAS NOTICED THAT THE STENT HAD SLIPPED BACK TO THE PROXIMAL SHAFT OF THE CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8516667 ↗