Orsiro 3.5/40/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 07640130439450), received between Apr 15, 2019 and Jun 8, 2022 — classified as 3 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (15 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 38 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 90 PERCENT STENOSIS DEGREE. THE STENT COULD NOT PASS THE LESION AND WAS WITHDRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634614 ↗
• MalfunctionFeb 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE PROXIMAL LAD. WHEN REMOVING THE PROTECTOR, IT WAS NOTICED THAT THE STENT WAS COMPLETELY LOOSE FROM THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541943 ↗
• MalfunctionFeb 16, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS RCA. AFTER ROTABLATION, SEVERAL ATTEMPTS WERE MADE TO PLACE THE ORSIRO STENT THROUGH THE 7F GUIDEZILLA, BUT THE STENT COULD NOT PASS THROUGH THE LESION. WHEN THE STENT WAS REMOVED FOR ADDITIONAL DILATATION, THE MID OF THE STENT WAS ROLLED UP. ANOTHER STENT WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541932 ↗
• MalfunctionJan 4, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE LAD. AFTER INTRODUCTION, THREE RADIOPAQUE MARKERS WERE SEEN ON THE ANGIOGRAPHY. IT WAS DECIDED TO WITHDRAW THE DEVICE AND A STENT DEFORMATION WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154749 ↗
• MalfunctionDec 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A TOTAL OCCLUSION IN THE RCA. A STENT WAS IMPLANTED AND POST STENT DILATED BUT IT THERE WAS NO FLOW. THEN THE ORSIRO WAS SELECTED FOR STENT PLACEMENT, BUT IT COULD NOT PASS AND WAS REMOVED. AFTER RE-INSERTION AND USING A GUIDEPLUS, IT WAS NOTICED THAT THE STENT WAS NOT CRIMPED ON THE BALLOON. THE STENT SYSTEM AND GUIDEPLUS WERE WITHDRAWN. IT WAS NOTICED THAT THE STENT WAS DISPLACED ON THE SHAFT OF THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13122182 ↗
• MalfunctionDec 29, 2021Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PREDILATED SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS DISTAL LAD. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. THE DEVICE WAS REMOVED FROM PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13115265 ↗
• MalfunctionDec 29, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING LESION CROSSING THE ORSIRO COULD NOT PASS THE PREDILATED SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS DISTAL LAD AND WAS DEFORMED. THE DEVICE WAS REMOVED FROM THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13115260 ↗
• MalfunctionDec 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 90 PERCENT STENOSIS DEGREE IN THE LAD. WHEN THE STENT WAS REMOVED FROM THE PROTECTOR, THE STENT WAS NOT ATTACHED TO THE BALLOON AND FELL OUT OF THE PROTECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010186 ↗
• MalfunctionNov 16, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION WITH 90 PERCENT STENOSIS DEGREE IN THE LAD. DESPITE PRE-DILATATION, THE DEVICE COULD NOT PASS THE LESION. AFTER WITHDRAWAL IT WAS DETECTED THAT THE STENT WAS DEFORMED AND WAS NOT USED ANYMORE. ANOTHER STENT WAS SELECTED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820976 ↗
• MalfunctionAug 19, 2021Decrease in Pressure; Decrease in Pressure

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING STENT DEPLOYMENT IT WAS NOT POSSIBLE TO FULLY INFLATE THE DELIVERY BALLOON. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12342386 ↗
• MalfunctionJul 7, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING PREPARATION, IT WAS NOTICED THAT THE EDGE OF THE STENT WAS DEFORMED AT THE DISTAL END. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127105 ↗
• MalfunctionMay 10, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS OSTIAL LAD. THE ORSIRO COULD NOT PASS THE LESION AND A STENT DEFORMATION WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803314 ↗
• MalfunctionApr 27, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE COULD NOT CROSS THE MILD CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SEVERE TORTUOUS DISTAL LAD AND THE STENT WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732775 ↗
• InjuryApr 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED PRE-DILATED LESION (90 PERCENT STENOSIS DEGREE) AT THE BIFURCATION OF THE LEFT CORONARY VESSEL. DURING THE ATTEMPT TO POSITION THE ORSIRO STENT INSIDE THE LESION, THE STENT DISLODGED FROM THE DELIVERY BALLOON. AFTER THAT THE GUIDEWIRE WAS USED TO PULL THE STENT NEAR THE ACCESS SITE. FINALLY, THE ARTERY WAS OPENED VIA SURGERY AND STENT WAS REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 11637683 ↗
• MalfunctionApr 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN MODERATELY TORTUOUS OSTIAL RCA. AFTER IVUS CONFIRMATION WAS ATTEMPT TO USE THE ORSIRO FOR DIRECT STENTING, BUT COULD NOT CROSS THE LESION. IT WAS TRIED TO PULL THE ORSIRO BACK BUT IT WAS NOTED THAT THE STENT HAS BEEN SHIFTED. AS THE STENT WAS STILL ON THE BALLOON IT WAS INFLATED AT THE PROXIMAL PART OF THE LESION AND THE DELIVERY SYSTEM WAS REMOVED. AFTER THAT THE ORSIRO STENT WAS DEPLOYED WITH SEMI-COMPLIANT BALLOON CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11631849 ↗
• MalfunctionMar 24, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (75 PERCENT STENOSIS DEGREE) IN THE LAD. AFTER PRE-DILATATION THE ORSIRO COULD NOT CROSS THE LESION. THEREFORE, IT WAS REMOVED FROM THE PATIENT AND ANOTHER LESION DILATATION WAS PERFORMED. A STENT DEFORMATION WAS NOTICED AND ANOTHER ORSIRO WAS USED FOR THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11563471 ↗
• MalfunctionFeb 19, 2021Inflation Problem; Inflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED PRE-DILATED LESION IN THE MILDLY TORTUOUS LAD. THE ORSIRO WAS DELIVERED TO THE LESION, BUT IT WOULD NOT INFLATE. THE INFLATION DEVICE WAS REPLACED, BUT THE BALLOON WOULD STILL NOT INFLATE. A DIFFERENT ORSIRO WAS USED WITH NO PROBLEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348507 ↗
• MalfunctionFeb 19, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PROXIMAL LAD. THE ORSIRO COULD NOT PASS THE LESION AND A DEFORMATION OF THE STENT WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11348495 ↗
• MalfunctionFeb 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN THE RCA. IT WAS ATTEMPTED TO IMPLANT THE ORSIRO INSIDE THE LESION BUT THE STENT DISLODGED FROM THE BALLOON.

  Patient problems: Insufficient Information

  MAUDE report 11266463 ↗
• MalfunctionDec 30, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE COULD NOT CROSS THE LESION AND UPON REMOVAL A STENT DEFORMATION HAS BEEN DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11098008 ↗
• MalfunctionDec 7, 2020Device 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). WHEN INSERTING THE DEVICE INTO THE GUIDING CATHETER THE STENT DISLODGED FROM THE BALLOON JUST OUTSIDE THE Y ADAPTER OUTSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10960111 ↗
• MalfunctionNov 3, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. AFTER PREDILATATION THE LESION COULD NOT BE CROSSED WITH THE ORSIRO. THE DEVICE WAS REMOVED FROM THE PATIENTS BODY AND 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 10781389 ↗
• MalfunctionOct 14, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING IT WAS NOTICED THAT THE STENT WAS DEFORMED. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10681229 ↗
• MalfunctionSep 29, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION IN A MILDLY TORTUOUS RCA. THE STENT FELL OFF THE BALLOON WHILE PLACING IT IN THE PROXIMAL RCA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10601324 ↗
• MalfunctionSep 21, 2020Inflation Problem; Inflation Problem

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE ORSIRO WAS DELIVERED TO THE LESION IN THE RCA AND TRIED FOR IMPLANTATION, BUT THE BALLOON COULD NOT BE INFLATED. THEREFORE, THE DEVICE WAS REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10560953 ↗