Orsiro 2.5/40/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 07640130439429), received between May 3, 2019 and Jun 6, 2022 — classified as 2 injuries, 47 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (23 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 25 most recent of 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 6, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS MID RCA. THE STENT DISLODGED DURING TAKING OFF THE PROTECTING SHEATH. ANOTHER STENT WAS PLACED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14605288 ↗
• MalfunctionMay 24, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS LCX. THE LESION COULD NOT BE PASSED WITH THE DEVICE. WHEN THE STENT WAS REMOVED FROM PATIENTS BODY, THE EDGE OF THE STENT WAS DEFORMED. THE STENT WAS NOT USED ANYMORE. THE CALCIFICATION WAS THEN REMOVED WITH A ROTABLATOR AND ANOTHER ORSIRO WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14488101 ↗
• MalfunctionMay 11, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS DISTAL LAD. THE PREDILATED LESION COULD NOT BE PASSED, AND THE STENT WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364777 ↗
• MalfunctionMay 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A RESTENOSIS IN A SAPHENOUS VEIN BYPASS. THE ORSIRO WAS ADVANCED TO THE TARGET LESION AND INFLATED WITH NP 8 ATM, BUT NO STENT WAS VISIBLE IN THE ANGIOGRAPHIC IMAGES. THE STENT WAS DISLODGED FROM THE BALLOON. THE STENT WAS NOT FOUND IN PATIENTS BODY. ANOTHER ORSIRO WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364696 ↗
• MalfunctionFeb 1, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS LAD. DURING DELIVERY THE DEVICE GOT CAUGHT AND COULD NOT REACH THE LESION. AFTER REMOVAL, IT WAS NOTICED THAT THE STENT WAS DEFORMED. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13417321 ↗
• MalfunctionJan 13, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN THE MODERATELY TORTUOUS LAD. IT WAS DIFFICULT TO DELIVER THE DEVICE TO THE TARGET LESION. AFTER REMOVAL FROM PATIENTS BODY, IT WAS NOTICED THAT THE STENT WAS DEFORMED AT THE EDGE. THE DEVICE WAS NOT USED ANYMORE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254212 ↗
• MalfunctionJan 6, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN THE RCA 3 TO 4, BUT IT DID NOT PASS THROUGH THE LESION PROBABLY BECAUSE ANOTHER STENT HAD ALREADY BEEN PLACED PROXIMAL TO THE LESION. AS IT WAS DECIDED TO WITHDRAW THE ORSIRO, THE STENT GOT DEFORMED AT THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177730 ↗
• MalfunctionJan 5, 2022Failure to Advance; Failure to Advance

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS DISTAL LCX. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167965 ↗
• 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 THE MILDLY TORTUOUS MID LAD. THE ORSIRO STENT COULD NOT PASS THE LESION AND GOT CAUGHT INSIDE. THUS, IT WAS DECIDED TO ADD A GUIDEPLUS II AND TRIED TO PASS THROUGH THE LESION BUT THE ORSIRO STENT DISLODGED FROM THE BALLOON INSIDE THE GUIDEPLUS II. THE DEVICE WAS REMOVED AND ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122152 ↗
• MalfunctionNov 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED SEVERELY CALCIFIED LESION IN THE MODERATELY TORTUOUS LCX. THE DEVICE GOT CAUGHT DURING DELIVERY TO THE LESION AND DISLODGED FROM THE BALLOON. THE DEVICE WAS REMOVED BY USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869718 ↗
• MalfunctionOct 6, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED PRE-DILATED LESION (90 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS LEFT CORONARY VESSEL. THE ORSIRO COULD NOT PASS THE LESION AND A DEFORMATION WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12583537 ↗
• MalfunctionOct 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. BEFORE THE DEVICE WAS ATTACHED TO THE INFLATION DEVICE, IT WAS DETECTED THAT THE STENT WAS ATTACHED TO THE PLASTIC COVER AND WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579832 ↗
• MalfunctionJul 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT WAS DAMAGED WHILE BEING PLACED ON THE WIRE. STENT WAS STRIPPED OFF OF THE DELIVERY BALLOON. STENT AND BALLOON WERE REMOVED FROM THE WIRE AND FROM STERILE FIELD. DEVICE NEVER ENTERED THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127629 ↗
• MalfunctionJul 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. WHILE REMOVING THE STENT PROTECTOR, THE STENT WAS ATTACHED TO THE PROTECTOR AND WAS PULLED OUT WITH IT. ANOTHER STENT WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127112 ↗
• MalfunctionJun 29, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING A STENT DEFORMATION WAS NOTICED. ANOTHER DEVICE WAS USED TO PROCEED WITH THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12087221 ↗
• MalfunctionMay 25, 2021Deflation Problem; Deflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LAD. AFTER SUCCESSFUL IMPLANTATION OF THE ORSIRO STENT IT WAS TRIED TO DEFLATE THE DELIVERY BALLOON BUT IT TOOK LONGER THAN USUAL. WHEN NEGATIVE PRESSURE WAS APPLIED ABOUT 30 SECONDS, THE BALLOON WAS FINALLY DEFLATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882019 ↗
• 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). AFTER PRE-DILATATION THE ORSIRO WAS DELIVERED THROUGH A GUIDEPLUS II EL (NIPRO) CATHETER, BUT COULD NOT CROSS THE LESION. THEN, THE ORSIRO WAS REMOVED FROM THE PATIENT AND IT WAS NOTICED THAT THE STENT EDGE WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806268 ↗
• MalfunctionApr 21, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED LESION (80 PERCENT STENOSIS DEGREE) IN THE LAD. A STENT DISLODGMENT HAD OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11704503 ↗
• MalfunctionApr 15, 2021Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE LESION COULD NOT BE CROSSED WITH THE DEVICE AND THE SHAFT OF THE DELIVERY SYSTEM BECAME DEFORMED WHILE TRYING TO PUSH IT THROUGH THE LESION. THE WHOLE DEVICE COULD BE REMOVED FROM PATIENTS BODY WITHOUT ANY PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11672069 ↗
• MalfunctionMar 3, 2021Device 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 A MILDLY TORTUOUS LAD. DURING LESION CROSSING RESISTANCE WAS FELT AND IT WAS DECIDED TO REMOVE THE ORSIRO. AFTER REMOVAL IT WAS TRIED TO DELIVER IT AGAIN BUT THE STENT DID NOT CROSS THE LESION AND WAS REMOVED FROM THE PATIENT AGAIN. UPON REMOVAL IT WAS NOTED THAT THE STENT HAS BEEN DISPLACED. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404958 ↗
• MalfunctionFeb 17, 2021Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339503 ↗
• MalfunctionJan 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. TO ADVANCE THE DEVICE TO THE PRE-DILATED TARGET LESION THE DEVICE HAD TO PASS A NON PRE-DILATED PROXIMAL LESION WHICH WAS NOT INTENDED TO BE TREATED. THE STENT DISLODGED IN THE PROXIMAL LESION AND WAS DEPLOYED THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11255177 ↗
• MalfunctionNov 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. ORSIRO STENT DISLODGEMENT OUTSIDE PATIENT IN THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10901107 ↗
• MalfunctionOct 1, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. AFTER REMOVAL IT WAS NOTICED THAT THE STENT WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10613607 ↗
• MalfunctionSep 21, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION OF THE LESION IN THE RCA THE ORSIRO WAS DELIVERED BUT COULD NOT CROSS. THEREFORE, A GUIDEPLUS WAS USED FOR SUPPORT TO DELIVER THE ORSIRO, BUT STILL THERE WAS A STRONG RESISTANCE AND THE DEVICE WAS REMOVED FROM THE PATIENT. AFTER REMOVAL IT WAS NOTED THAT THE STENT EDGE WAS EVERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10560961 ↗