Orsiro 2.25/26/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07640130439146), received between Mar 29, 2019 and Aug 8, 2022 — classified as 2 deaths, 34 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (22 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. INITIALLY, THE DEVICE DID NOT CROSS THE LESION. WHEN REMOVING IT FROM PATIENTS BODY, THE STENT REWRAPPED. THE PROXIMAL EDGE OF STENT IS EXTREMELY CLOSE TO CLIP ON DELIVERY SYSTEM. UDI (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15183115 ↗
• MalfunctionJul 26, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. UPON UNPACKING AND REMOVING THE PROTECTOR CAP, THE STENT DISLODGED FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15103762 ↗
• MalfunctionJun 29, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A SEVERELY CALCIFIED VESSEL WITH MODERATE TORTUOSITY WAS PRE-DILATED WITH COMPLIANT AND NON-COMPLIANT BALLOONS WITH SUPPORT FROM 6F GUIDELINER. IT WAS REPORTED THAT A CONSIDERABLE AMOUNT OF FORCE WAS APPLIED IN ATTEMPT TO CROSS THE LESION. THE STENT WAS NOTED ON FLUOROSCOPY TO BE DISLODGED FROM MARKERS AND PUSHED BACK ONTO THE CATHETER. THE CATHETER WAS WALKED OUT OVER THE WIRE WHERE THE STENT COMPLETELY DISLODGED FROM THE CATHETER INTO THE CO-PILOT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14851812 ↗
• MalfunctionApr 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE WAS REMOVED FROM THE TRANSPORTATION RING, BUT THE STENT HAD DISLODGED DURING PREPARATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13976720 ↗
• MalfunctionFeb 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN THE LCX. AFTER PRE-DILATATION DURING ATTEMPT TO CROSS THE LESION, THE STENT COMPLETELY DETACHED FROM THE DELIVERY SYSTEM. THE STENT WAS SUCCESSFULLY REMOVED WITH A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541953 ↗
• MalfunctionFeb 7, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER PREDILATATION FOR TWO TIMES, THE ORSIRO WAS INSERTED AND CHECKED BY (B)(6), BUT THE STENT COULD NOT BE CONFIRMED. FINALLY, THE STENT WAS FOUND ON THE FLOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13471101 ↗
• MalfunctionNov 10, 2021Device 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) IN THE MODERATELY TORTUOUS MID LAD. THE DEVICE COULD NOT PASS THE HEMOSTASIS VALVE. AFTER WITHDRAWAL IT WAS DETECTED THAT THE STENT WAS DISLODGED FROM BALLOON. THE STENT WAS LOCATED AT THE END OF THE GUIDING CATHETER. THE STENT WAS RETRIEVED WITH A BALLOON TOGETHER WITH THE GUIDE WIRE AND GUIDING CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12787405 ↗
• MalfunctionOct 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT WAS NOT ON THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579826 ↗
• MalfunctionSep 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING THE STENT DISLODGED FROM THE BALLOON WHILE REMOVING FROM THE TRANSPORTATION RING. THE DEVICE WAS NOT USED. ANOTHER STENT SYSTEM WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12540810 ↗
• MalfunctionSep 23, 2021Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT COULD NOT BE DELIVERED THROUGH THE MODERATELY CALCIFIED LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12518357 ↗
• DeathJul 14, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2021 THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH MASSIVE MYOCARDIAL INFARCTION. THE AFFECTED VESSEL SEGMENT (LAD, MEDIAL TO DISTAL) WAS TREATED WITH 2.75/26 DES AND POST-DILATED WITH 3.0 NC BALLOON. UPON DILATATION, AN ADDITIONAL MORE DISTAL LESION WAS DETECTED. FOR THIS TREATMENT THE AFFECTED 2.25/26 ORSIRO WAS CHOSEN, BUT IT WAS NOT POSSIBLE TO PASS THROUGH THE PREVIOUSLY IMPLANTED DES. DURING WITHDRAWAL THE ORSIRO STENT DISLODGED FROM THE BALLOON AND WAS ADAPTED TO THE VESSEL WALL USING ANOTHER BALLOON CATHETER. IT WAS REPORTED THAT THE PATIENT DIED SEVERAL DAYS AFTER THE PROCEDURE. ACCORDING TO THE TREATING PHYSICIAN, THE DEATH WAS NOT DEVICE RELATED AS THE PATIENT WAS ALREADY IN CRITICAL CONDITION AT HOSPITAL ADMISSION WITH MASSIVE MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 12170516 ↗
• MalfunctionMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS PROXIMAL LAD. AFTER PRE-DILATATION, DURING ATTEMPT TO CROSS THE LESION, IT WAS DETECTED THAT THE STENT GOT DISLODGED FROM THE DELIVERY SYSTEM. THE STENT WAS RETRIEVED. ANOTHER STENT SYSTEM WAS USED AFTERWARDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889616 ↗
• 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 A SEVERELY TORTUOUS LAD. THE ORSIRO COULD NOT PASS THE LESION AND A STENT DEFORMATION WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11797124 ↗
• MalfunctionApr 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (99 PERCENT STENOSIS DEGREE) IN THE MID LAD. DURING PREPARATION IT WAS DETECTED THAT THE STENT WAS DISLODGED FROM DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637626 ↗
• MalfunctionMar 29, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER REMOVAL OF THE STENT PROTECTOR, WHILE THREADING THE DEVICE ON THE GUIDE WIRE, A DEFORMATION OF THE STENT WAS DETECTED. THE DEVICE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11581909 ↗
• MalfunctionMar 3, 2021Inflation Problem; Inflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS LAD. DESPITE TWO ATTEMPTS, IT WAS NOT POSSIBLE TO INFLATE THE BALLOON. AFTER REMOVAL IT WAS NOTICED THAT THE STENT WAS STILL ON THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404972 ↗
• MalfunctionJan 13, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS RCA. DESPITE PRE-DILATATION THE LESION COULD NOT BE CROSSED WITH THE DEVICE. A STENT DEFORMATION WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11167752 ↗
• MalfunctionJan 12, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS LAD. IT WAS NOT POSSIBLE TO PUSH THE STENT ACROSS ANOTHER STENT ON LM-PLAD. THE STENT WAS WITHDRAWN AND CHECKED WHICH SHOWED THAT ONE STRUT OF THE STENT WAS DEFORMED AND PROTRUDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156919 ↗
• MalfunctionDec 10, 2020Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE OSTIAL OM. IT WAS NOT POSSIBLE TO CROSS THE CALCIFIED LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10984816 ↗
• MalfunctionOct 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT BUT THE LESION COULD NOT BE CROSSED. DURING WITHDRAWAL INTO THE GUIDING CATHETER THE DEVICE GOT STUCK INSIDE AND THE STENT BECAME DEFORMED. DURING WITHDRAWAL OF ALL MATERIAL THE STENT DISLODGED FINALLY IN THE INTRODUCER AND FLOATED INTO THE FEMORAL ARTERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10627962 ↗
• MalfunctionOct 5, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. DURING LESION CROSSING THE STENT BECAME DEFORMED AT THE PROXIMAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10627961 ↗
• MalfunctionSep 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN SEVERELY TORTUOUS MID LCX. THE LESION COULD NOT BE CROSSED WITH THE DEVICE AND THE STENT DISLODGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488798 ↗
• MalfunctionSep 3, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE IN SEVERELY TORTUOUS MID LAD.) THE LESION COULD NOT BE CROSSED WITH THE DEVICE. IT WAS DETECTED THAT THE STENT WAS DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10488797 ↗
• MalfunctionAug 3, 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 RCA. AFTER ROTABLATION AND PRE-DILATATION, THE DEVICE WAS INTRODUCED BUT RESISTANCE WAS FELT PROXIMAL TO THE LESION, SO THE ORSIRO WAS REMOVED. THEN, IT WAS NOTICED THAT THE STENT WAS DEFORMED AT ITS DISTAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10359013 ↗
• MalfunctionApr 29, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PREPARATION WITH A ROTABLATOR AND PRE-DILATATION RESISTANCE WAS FELT WHILE WHILE ADVANCING THE DEVICE TO THE TARGET LESION. AFTER WITHDRAWAL A STENT DEFORMATION WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10009808 ↗