Orsiro 2.5/35/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 07640130439368), received between Apr 11, 2019 and May 11, 2022 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

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

  AFTER THE FIRST ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE MODERATELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS MID LAD (REPORTED SEPARATELY) THE SECOND ORSIRO WAS SELECTED FOR TREATMENT. AGAIN THE THE LESION COULD NOT BE CROSSED WITH THE DEVICE. THE DEVICE WAS WITHDRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14364604 ↗
• MalfunctionApr 26, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS LCX. THE DEVICE COULD NOT CROSS THE LESION BY DIRECT STENTING AND WAS WITHDRAWN. AFTERWARDS, IT WAS DETECTED THAT THE STENT WAS DEFORMED (FLUFFY).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14207954 ↗
• MalfunctionApr 7, 2022Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION WITH 85 PERCENT STENOSIS DEGREE. DESPITE PRE-DILATATION THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14047481 ↗
• MalfunctionJan 13, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED LESION. THE STENT DISLODGED INSIDE THE GUIDING CATHETER. THE GUIDING CATHETER WITH THE STENT INSIDE WAS REMOVED. THE INTERVENTION WAS COMPLETED WITH ANOTHER ORSIRO STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13254243 ↗
• MalfunctionSep 15, 2021Device Dislodged or Dislocated; Unexpected Color; Device Dislodged or Dislocated; Unexpected Color

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING IT WAS NOTICED THAT THE STENT WAS DETACHED FROM THE DELIVERY SYSTEM. IT WAS ALSO MENTIONED THAT THE COLOR WAS NOT AS USUAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474414 ↗
• InjuryAug 17, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT ADMITTED AT THE HOSPITAL ON (B)(6) 2021 WITH ACUTE MYOCARDIAL INFARCTION AND DIAGNOSIS OF ANTIPHOSPHOLIPID ANTIBODY SYNDROME. AN ORSIRO DES WAS SELECTED FOR TREATMENT OF THE LAD DIAGONAL BRANCHES. SEVEN DAYS LATER, THORACIC ISCHEMIC SYMPTOMS RECURRED. DURING CONTROL ANGIOGRAPHY A OCCLUSION PROXIMAL TO THE DES WAS OBSERVED AND TREATED WITH POBA. THE PATIENT WAS DISCHARGED AFTERWARDS. THE PHYSICIAN COMMENTED THAT THIS EVENT OCCURRED MORE LIKELY DUE TO DRUG DOSAGE TIMING RATHER THAN DEVICE RELATED ISSUE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12334289 ↗
• InjuryJun 8, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. TWO DAYS AFTER IMPLANTATION OF THE ORSIRO A STENT THROMBOSIS WAS DETECTED. TREATMENT WITH DRUG COATED BALLOON AND IABP.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 11957219 ↗
• MalfunctionFeb 4, 2021Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. DURING UNPACKING AND REMOVING OF THE STENT PROTECTOR A STENT DEFORMATION WAS NOTICED. THUS ANOTHER DEVICE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279539 ↗
• MalfunctionDec 16, 2020Failure 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 SEVERELY CALCIFIED LESION (96 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS MID RCA. IT WAS ATTEMPTED TO INSERT THE DEVICE THROUGH THE LESION BUT RESISTANCE WAS FELT. UPON WITHDRAWAL THE STENT DISLODGED FROM BALLOON AND WAS REMOVED FROM PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11018715 ↗
• MalfunctionSep 14, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS RCA. AFTER PREDILATATION THE ORSIRO SYSTEM WAS DELIVERED THROUGH A GUIDEPLUS EXTENSION CATHETER BUT COULD NOT PASS THE LESION AND WAS REMOVED FROM THE PATIENT. IT WAS DETECTED THAT THE STENT WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10532502 ↗
• MalfunctionJul 15, 2020Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE LESION IN THE MODERATE TORTUOUS LCX COULD NOT BE PASSED AFTER PRE-DILATATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10279766 ↗
• MalfunctionJul 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (98 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS RCA. DURING DEVICE INTRODUCTION RESISTANCE WAS FELT SO IT WAS DECIDED TO USE A GUIDEZILLA EXTENSION CATHETER BUT STILL RESISTANCE WAS FELT. UPON REMOVAL THE ORSIRO STENT SYSTEM GOT CAUGHT AT THE GUIDEZILLA, THE STENT DISLODGED FROM BALLOON AND WAS ADAPTED TO THE VESSEL WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10248467 ↗
• MalfunctionJun 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING UNPACKING, THE STENT DETACHED FROM THE BALLOON WHEN REMOVED FROM THE PROTECTIVE SPIRAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10188491 ↗
• MalfunctionMar 10, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED PRE-DILATED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PROXIMAL LAD. THE DEVICE COULD NOT PASS THE LESION AND A STENT DEFORMATION WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812179 ↗
• MalfunctionMar 10, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED PRE-DILATED LESION (90 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PROXIMAL LAD. THE DEVICE COULD NOT PASS THE LESION AND A STENT DEFORMATION WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9812174 ↗
• MalfunctionFeb 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-COATED STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER UNPACKING IT WAS NOTICED THAT THE STENT DISLODGED FROM DELIVERY SYSTEM BEFORE INTRODUCTION INTO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9757274 ↗
• MalfunctionFeb 6, 2020Difficult to Remove; Difficult to Remove

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION IN THE MID LAD. DURING LESION CROSSING RESISTANCE WAS FELT. THUS THE DEVICE WAS REMOVED WITH DIFFICULTIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9676492 ↗
• MalfunctionAug 22, 2019Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE). DURING THE PROCEDURE THE STENT WAS DAMAGED AT THE TIP OF AN 6F TELEFLEX GUIDELINER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923078 ↗
• MalfunctionJul 15, 2019Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION IN A CX. DESPITE USING A ROTABLATOR THE DEVICE COULD NOT PASS THE LESION. UPON REMOVAL THE STENT HAD SUSTAINED SOME DAMAGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791670 ↗
• MalfunctionJun 19, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (95% STENOSIS DEGREE) IN A PROXIMAL ARTERY. THE DEVICE WAS UNABLE TO CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712227 ↗
• MalfunctionJun 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER UNPACKING THE PHYSICIAN DETECTED THAT THE STENT WAS DISLODGED AND THE SYSTEM WAS THEREFORE NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712191 ↗
• MalfunctionMay 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT COULD NOT PASS THE CALCIFIED LESION IN THE LAD AND DISLODGED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591642 ↗
• MalfunctionApr 11, 2019Fluid/Blood Leak; Fluid/Blood Leak

  OUS MDR - THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. A DEVICE LEAKAGE WAS OBSERVED BEFORE BALLOON INFLATION. TRUE LOT NUMBER IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506556 ↗