Orsiro 4.0/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07640130439078), received between Apr 16, 2019 and Feb 1, 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 16, 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 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING PREPARATION AND REMOVING THE PROTECTOR THE STENT DISLODGED FROM THE BALLOON OUTSIDE OF THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417314 ↗
• MalfunctionJan 25, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING PREPARATION THE STENT FELL OFF THE BALLOON. THE DISLODGEMENT WAS DETECTED AFTER THE DEVICE WAS INTRODUCED INTO PATIENT. ANOTHER SENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13343016 ↗
• MalfunctionSep 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATE CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS RCA. IT WAS ATTEMPTED TO IMPLANT TWO ORSIROS. AFTER THE FIRST WAS DEPLOYED SUCCESSFULLY THE SECOND DEVICE WAS INTRODUCED BUT COULD NOT BE ADVANCED. UPON WITHDRAWAL, THE STENT DISLODGED FROM BALLOON AND COULD NOT BE RETRIEVED. THE STENT WAS ADAPTED TO THE VESSEL WALL IN THE RIGHT RADIAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518354 ↗
• MalfunctionMay 10, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A STENOSIS (98 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS MID RCA. DURING ATTEMPT TO CROSS THE LESION RESISTANCE WAS FELT AND THE DEVICE WAS PULLED BACK. PROXIMAL TO THE GUIDING CATHETER THE STENT DISLODGED. THE STENT WAS SNARED TO THE RIGHT ILIAC AND ADAPTED TO THE VESSEL WALL WITH A STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797128 ↗
• MalfunctionMar 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE MID RCA. THE ORSIRO WAS INSERTED THROUGH THE Y-CONNECTOR BUT RESISTANCE WAS FELT UND IT WAS DECIDED TO REMOVE THE DEVICE. UPON REMOVAL IT WAS NOTICED THAT THE STENT HAS BEEN DISLODGED FROM THE BALLOON AND STAYED INSIDE THE Y-CONNECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11499401 ↗
• MalfunctionOct 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SVG. PRIOR TO ANY PORTION OF DEVICE ENTERING PATIENTS BODY, STENT FELL OFF DELIVERY SYSTEM INTO OPERATORS HAND. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10750271 ↗
• MalfunctionAug 20, 2020Material Rupture; Material Rupture

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE LCX. AFTER PRE-DILATATION IT WAS ATTEMPTED TO INFLATE THE DELIVERY BALLOON OF THE ORSIRO STENT SYSTEM BUT THE BALLOON COULD NOT BE INFLATED COMPLETELY AT 8 ATM. THE PRESSURE WAS INCREASED UP TO 16 ATM AND THE DEPLOYMENT WAS SUCCESSFUL. DUE TO THE INFLATION ISSUES A BALLOON PINHOLE WAS SUSPECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10430455 ↗
• MalfunctionJun 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING SENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS LAD. RESISTANCE WAS FELT DURING INSERTION AND THE DEVICE WAS REMOVED FROM THE PATIENTS BODY BUT THE STENT WAS MISSING. UPON AN ADDITIONAL ANGIOGRAPHIC CHECK THE DISLODGED STENT WAS FOUND INSIDE AND REMOVED BY USING A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10202632 ↗
• MalfunctionMay 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS LCX. THE DEVICE COULD NOT PASS THE PRE-DILATED LESION. DURING WITHDRAWAL THE STENT DISLODGED. THE STENT WAS RETRIEVED WITH ANOTHER BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10040144 ↗
• MalfunctionMay 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE RCA. THE DEVICE COULD NOT CROSS THE LESION AND WAS REMOVED. THE SAME ORSIRO WAS DELIVERED AGAIN THROUGH TELESCOPE GUIDEZILLA, BUT COULD NOT BE DELIVERED. IT WAS NOTED THAT THE STENT WAS DISLODGED. THE STENT WAS RETRIEVED WITH A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10018860 ↗
• MalfunctionJul 15, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION IN A RCA. THE DEVICE COULD NOT CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791642 ↗
• MalfunctionMay 3, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE CALCIFIED AND TORTUOUS LESION IN THE RCA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580047 ↗
• MalfunctionApr 16, 2019Burst Container or Vessel; Burst Container or Vessel

  OUS MDR - DURING INFLATION THE BALLOON OF THE ORSIRO DRUG-ELUTING STENT SYSTEM RUPTURED AT 20 BAR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8520868 ↗