Orsiro 2.25/9/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07640130438842), received between Jun 18, 2019 and Jan 14, 2022 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS DISTAL RCA / PDA. AFTER SEVERAL PRE-DILATATION AND SEVERAL ATTEMPTS TO CROSS THE LESION WITH OTHER STENTS AND A CUTTING BALLOON, THE ORSIRO WAS INTRODUCED BUT COULD NOT CROSS THE LESION EITHER. AFTER WITHDRAWAL THE STENT DISLODGED OUTSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13258628 ↗
• MalfunctionJun 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A 9MM LONG LESION IN THE SEVERELY TORTUOUS CX. THE STENT DISLODGED FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917272 ↗
• MalfunctionMay 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THIS WAS A DIFFICULT PCI WITH A VERY TORTIOUS VESSEL. PRIOR TO THE EVENT, THERE WERE SEVERAL STENTS THAT WERE UNABLE TO CROSS THE LESION. THE ORSIRO STENT WAS ABLE TO CROSS BUT IT APPEARED THERE WAS A DISSECTION FLAP. UPON INFLATING THE ORSIRO, THEY REALIZED WHAT THEY THOUGHT WAS A DISSECTION FLAP WAS ACTUALLY THE STENT THAT HAD BECOME DISLODGED. THIS EVENT WAS REPORTED PER FDA MEDWATCH MW5099918.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11838274 ↗
• MalfunctionMar 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE). THE STENT WAS DELIVERED TO THE LESION BUT FAILED TO CROSS. UPON REMOVAL, THE STENT WAS NOT OBSERVED TO BE ON THE BALLOON AND WAS SEEN ON FLUOROSCOPY TO BE WITHIN THE VESSEL. THE STENT WAS WITHDRAWN INTO THE GUIDING CATHETER AND REMOVED INSIDE THE CATHETER FROM PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496502 ↗
• MalfunctionFeb 12, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT DISLODGED FROM THE BALLOON. THE UNDEPLOYED STENT WAS PUSHED FORWARD AND DEPLOYED IN SITU.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11322788 ↗
• MalfunctionMay 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF THE TARGET LESION IN THE LAD. DURING LESION CROSSING THE STENT DISLODGED FROM THE BALLOON BUT WAS SUCCESSFULLY CAPTURED AND DILATED OVER THE WIRE USING DIFFERENT BALLOON. EVENTUALLY THE STENT DEPLOYED AT UNDESIRED LOCATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10036618 ↗
• MalfunctionFeb 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSRIO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A LESION (90 PERCENT STENOSIS DEGREE) IN A TORTUOUS PROXIMAL POSTERIOR LEFT VENTRICULAR ARTERY BRANCH OF THE RCA. UPON DEPLOYMENT NO STENT WAS SEEN IN A STENT BOOST. NO STENT WAS FOUND, NEITHER IN THE VESSEL NOR ON THE TABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9695311 ↗
• MalfunctionNov 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A PRE-DILATED SEVERELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS DISTAL CX. WHILE TRYING TO CROSS AN PREVIOUSLY IMPLANTED STENT, THE ORSIRO STENT DISLODGED PROXIMAL TO THE LESION. THE STENT WAS ATTACHED INSIDE THE PREVIOUS STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9379617 ↗
• MalfunctionOct 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING IT WAS DETECTED THAT THERE WAS NO STENT ON THE BALLOON. THE DEVICE WAS NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9251580 ↗
• MalfunctionSep 25, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A PRE-DILATED CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A SEVERE TORTUOUS OM. DURING LESION CROSSING THE ORSIRO STENT DISLODGED FROM THE BALLOON AND STAYED INSIDE THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9118522 ↗
• MalfunctionAug 15, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  FDA REPORT MW5088019 AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. WHILE ADVANCING THE DEVICE, THE STENT SEPARATED FROM BALLOON WITHOUT BEING DEPLOYED AND WAS FLOATING IN THE ARTERY. ANOTHER STENT WAS INSERTED AND DEPLOYED OVER LOOSE STENT MASHING IT TO THE WALL. A NON-COMPLIANT BALLOON WAS INSERTED AND TAKEN UP TO HIGH PRESSURE TO ENSURE THAT THE LOOSE STENT WAS TIGHTLY TRAPPED. A THIRD STENT WAS DEPLOYED TO FIX THE STENOSIS WITHOUT FURTHER INCIDENT. THE CORRECT LOT NUMBER IS NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8896342 ↗
• MalfunctionJul 1, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A TORTUOUS LAD. DURING ATTEMPT TO CROSS A PREVIOUS IMPLANTED STENT RESISTANCE WAS FELT. UPON REMOVAL IT WAS NOTICED THAT THE STENT DISLODGED FROM THE SYSTEM. THE STENT WAS RETRIEVED WITH A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750623 ↗
• MalfunctionJun 28, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION IN AN EXTREME TORTUOUS VESSEL. DURING PROCEDURE THE STENT DISLODGED. NO LOT NUMBER WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8746028 ↗
• MalfunctionJun 19, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. THE DEVICE WAS UNABLE TO CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712233 ↗
• MalfunctionJun 18, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT WAS CHOSEN FOR TREATMENT. THE DEVICE DID NOT PASS LESION. DURING WITHDRAWAL THE SENT DISLODGED AND WAS ADAPTED TO THE VESSEL WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707959 ↗