Orsiro 2.75/40/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07640130439436), received between May 27, 2019 and May 11, 2022 — classified as 1 death, 1 injury, 16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF MODERATELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID LAD. THE THE LESION COULD NOT BE CROSSED WITH THE DEVICE. IT WAS DETECTED THAT THE STENT WAS DEFORMED. ANOTHER ORSIRO WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364565 ↗
• DeathApr 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS ADMITTED FOR NON-ST-ELEVATION MYOCARDIAL INFRACTION WITH SEVERE MULTI-VESSEL CORONARY ARTERY DISEASE. AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, WHILE THE PROVIDER WAS ATTEMPTING TO ADVANCE THE ORSIRO ACROSS THE PROXIMAL PORTION OF THE LESION, THE STENT WAS NOT ABLE TO BE ADVANCED ANY FURTHER. STENT WAS WITHDRAWN. STENT BECAME STRIPPED OFF THE BALLOON. SEVERAL SMALLER BALLOONS WERE THEN USED TO GO BACK INTO THE STENT TO TRY TO DEPLOY IT, AND IT DID FINALLY DEPLOY. AT THIS TIME THE PATIENTS CONDITION DETERIORATED. CODE ARREST AND EXPIRED. THIS EVENT WAS REPORTED BY HOSPITAL UNDER MEDWATCH REF. (B)(4).

  Patient problems: Cardiac Arrest

  MAUDE report 14207940 ↗
• MalfunctionMar 23, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS MID LAD. DESPITE PRE-DILATATION THE LESION COULD NOT BE PASSED WITH THE DEVICE, AND THE STENT DISLODGED FROM THE BALLOON. THE GUIDEWIRE WAS USED TO REMOVE THE DISLODGED STENT FROM PATIENTS BODY, AND THE PROCEDURE WAS FINISHED BY USING ANOTHER STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13871117 ↗
• MalfunctionDec 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PROXIMAL LAD AND AN ISR IN THE DISTAL LAD. AFTER PRE-DILATATION AN ORSIRO STENT WAS SUCCESSFULLY IMPLANTATION IN THE PROXIMAL LAD. THE SECOND ORSIRO 2.75/40 WAS SELECTED TO TREAT THE DISTAL ISR BUT COULD NOT PASS THROUGH THE ALREADY IMPLANTED STENT AND IT WAS DECIDED TO REMOVE IT FOR FURTHER BALLOON DILATATIONS. SINCE THE BALLOON COULD NOT PASS IT WAS DECIDED THAT THE LESION WAS TOO TIGHT AND THE GUIDEWIRE WAS REMOVED. DURING THE CONTROL ANGIO IT WAS NOTICED THAT THE STENT HAS BEEN DISLODGED FROM THE BALLOON BY GETTING CAUGHT AT THE GUIDING CATHETER. THE PHYSICIAN TRIED TO REMOVE THE STENT WITH A SNARE. THE PATIENT WAS SENT TO CV SURGERY. THE PATIENT WAS FINALLY DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122155 ↗
• MalfunctionSep 28, 2021Inflation Problem; Inflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF MILDLY CALCIFIED PRE-DILATED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS MID LCX. THE DELIVERY BALLOON OF THE ORSIRO STENT SYSTEM DID NOT FULLY EXPAND AT 8 ATM. THE PRESSURE WAS INCREASED UP TO 10 ATM AND THE BALLOON FULLY EXPANDED. THE STENT WAS DEPLOYED. DURING THE SECOND EXPANSION THE BALLOON COULD NOT HOLD THE PRESSURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540769 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MODERATE TORTUOUS MID RCA. AFTER PRE-DILATATION THE ORSIRO COULD NOT CROSS THE LESION. THUS IT WAS REMOVED AND A GUIDE ACCESS WAS INTRODUCED. AFTER RE-INSERTION OF THE ORSIRO THE GUIDE FLICKED OUT OF THE RCA ACCESS AND THE STENT STRUTS GOT CAUGHT ON THE RIM OF THE GUIDE DURING THE ATTEMPT TO REMOVE THE ORSIRO. THUS BOTH HAD TO BE REMOVED TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806261 ↗
• MalfunctionJan 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN MODERATELY TORTUOUS LAD. DUE TO CALCIFICATION AND TORTUOUS VESSEL, A GUIDEPLUS II EL WAS USED. DURING DELIVERY OF ORSIRO, IT GOT CAUGHT IN THE GUIDEPLUS II EL FOR THREE TIMES BUT COULD BE DELIVERED. THE BALLOON WAS SLOWLY INFLATED BUT ABNORMALITY WAS FELT, SO THE ORSIRO WAS REMOVED. IT WAS NOTICED THAT THE STENT WAS STILL ON THE PROXIMAL SHAFT. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167804 ↗
• MalfunctionJan 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING STENT PLACEMENT IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT WAS STILL INSIDE THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125768 ↗
• MalfunctionOct 14, 2020Device 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) AT A BIFURCATION OF LAD AND DIAGONAL ARTERY. AFTER POSITIONING THE ORSIRO STENT SYSTEM INSIDE THE LESION IT WAS NOT POSSIBLE TO POSITION ANOTHER STENT. THE STENTS GOT STUCK IN EACH OTHER. THUS, BOTH STENTS HAD TO BE REMOVED. IT APPEARED THAT THE ORSIRO WAS DISPLACED PROXIMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10681257 ↗
• MalfunctionSep 29, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (90 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS LCX. THE STENT COULD NOT PASS THE LESION AND UPON REMOVAL A STENT DEFORMATION WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10601327 ↗
• MalfunctionAug 18, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. STENT WOULD NOT CROSS LESION AND WAS REMOVED. IT WAS NOTED TO BE MISSHAPEN AND STRUT MISALIGNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10422842 ↗
• MalfunctionAug 11, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS RCA. DURING LESION CROSSING RESISTANCE WAS FELT AND IT WAS DECIDED TO REMOVE THE STENT. UPON WITHDRAWAL THE STENT DISLODGED FROM THE BALLOON AND WAS EVENTUALLY REMOVED BY USING A SNARE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10393636 ↗
• MalfunctionMar 30, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE DEVICE WAS INSERTED BUT THE TARGET LESION COULD NOT BE CROSSED. AFTER WITHDRAWAL IT WAS DETECTED THAT THE STENT WAS DISTALLY DEFORMED AND SHIFTED TO THE DISTAL POSITION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9901636 ↗
• MalfunctionMar 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO US DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A SEVERE CALCIFIED LESION IN THE MID LAD. DURING PROCEDURE THE MID SHAFT OF THE DEVICE WAS BENT. IN THE ATTEMPT TO REMOVE THE DEVICE THE STENT DISLODGED FROM BALLOON. WHEN TRYING TO REMOVE THE STENT WITH A BALLOON THE STENT WAS MANGLED. THE STENT WAS FINALLY REMOVED FROM THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9878382 ↗
• MalfunctionJan 9, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING PREPARATION THE STENT DISLODGED DURING REMOVAL OF THE PROTECTION CAP OUTSIDE PATIENTS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569398 ↗
• InjuryJan 7, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A LESION (75 PERCENT STENOSIS DEGREE) IN THE LAD. 3 DAYS AFTER IMPLANTATION PATIENT EXPERIENCED CHEST PAIN AND A STENT THROMBOSIS WAS DETECTED. ASPIRATION WAS DONE.

  Patient problems: Thrombosis

  MAUDE report 9558037 ↗
• MalfunctionDec 9, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE THE ORSIRO COULD NOT PASS THE CALCIFIED LESION IN THE RCA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9440920 ↗
• MalfunctionMay 27, 2019Failure to Advance; Failure to Advance

  AFTER PRE-DILATATION THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE SEVERELY CALCIFIED LESION IN THE RCA AND WAS THEREFORE REMOVED FROM THE PATIENTS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8644275 ↗