Orsiro 3.5/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07640130439061), received between Apr 3, 2019 and Jul 5, 2022 — classified as 1 injury, 25 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION OBSERVED IN RCA. PRE-DILATATION WAS PERFORMED BY USING A SCORING BALLOON WITH GUIDE EXTENSION SUPPORT. AN ATTEMPT WAS MADE TO PLACE THE ORSIRO, BUT IT WAS REMOVED FROM THE BODY DUE TO RESISTANCE BEFORE THE LESION. AT THAT TIME, THE STENT WAS DEFORMED, AND IT WAS JUDGED THAT IT HAD SLIGHTLY DISLODGED. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14919639 ↗
• MalfunctionOct 5, 2021Inflation Problem; Inflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE BALLOON COULD NOT BE INFLATED, AND THEREFORE THE STENT COULD NOT BE DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579830 ↗
• MalfunctionSep 9, 2021Fracture; Fracture

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN THE LAD. DURING ATTEMPT TO DELIVER THE ORSIRO BY DIRECT STENTING, THE DEVICE BROKE AT THE HUB. THE DEVICE WAS REMOVED AND ANOTHER ORSIRO OF SAME SIZE WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12446434 ↗
• MalfunctionJul 14, 2021Activation Failure; Activation Failure

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE BALLOON DID NOT INFLATE AND THE PRESSURE DID NOT RISE. THE ORSIRO WAS REMOVED AND THE INTERVENTION WAS COMPLETED WITH AND OTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12166359 ↗
• MalfunctionMay 21, 2021Failure 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 MODERATELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS MID LAD. THE DEVICE WAS ADVANCED OVER GUIDEWIRE THROUGH GUIDELINER INSIDE CATHETER, BUT DID NOT MAKE IT TO THE LESION. IT GOT CAUGHT ON EDGE OF CATHETER/GUIDELINER AND THE STENT DISLODGED. THE STENT WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11863032 ↗
• MalfunctionFeb 19, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CTO. PREDILATATION WAS CONDUCTED AND A GUIDELINER WAS USED TO GET THE STENT TO CROSS. HOWEVER, THE STENT GOT DAMAGED AT THE TIP SO ANOTHER ONE WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11350929 ↗
• MalfunctionFeb 16, 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 SEVERELY TORTUOUS RCA. AFTER PREDILATATION THE TARGET LESION COULD NOT BE CROSSED. DURING WITHDRAWAL THE PROXIMAL EDGE OF THE STENT GOT CAUGHT ON THE EDGE OF THE GUIDELINER AND PUSHED THE STENT OFF OF THE BALLOON. AS THE STENT WAS STILL ON THE WIRE IT WAS POSSIBLE TO REMOVE THE DISLODGED STENT WITH THE WIRE FROM THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334805 ↗
• MalfunctionFeb 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE RCA. AFTER PRE DILATATION AND IVUS, THE ORSIRO WAS ATTEMPTED TO BE IMPLANTED, BUT IT WAS DIFFICULT TO DELIVER DUE TO HIGH CALCIFICATION AND TORTUOUS VESSEL. THE GUIDING CATHETER WAS RE ENGAGED, A GUIDEPLUS WAS USED AND THE ORSIRO WAS ATTEMPTED TO BE DELIVERED AGAIN. THEREBY, IT WAS NOTICED THAT THE STENT WAS DISLODGED. THE STENT COULD NOT BE CONFIRMED IN THE CORONARY ARTERY AND IT WAS FOUND NEAR THE EXTERNAL ILIAC ARTERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 11334803 ↗
• MalfunctionDec 16, 2020Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (75 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS RCA. THE DEVICE COULD NO PASS THE LESION. ANOTHER ORSIRO WAS USED TO PROCEED WITH THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11018723 ↗
• MalfunctionDec 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO WAS CHOSEN TO TREAT A SEVERE CALCIFIED LESION IN A MODERATE TORTUOUS VESSEL WITH A STENOSIS DEGREE OF 99 PERCENT AFTER PRE-DILATATION. THE STENT DISLODGED FROM THE BALLOON WITH EMBOLIZATION IN THE AORTA. THE STENT REMAINS IN PATIENT AND WAS ADAPTED TO THE VESSEL WALL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10970119 ↗
• MalfunctionDec 1, 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 THE RCA. IT WAS TRIED MULTIPLE TIMES TO GET STENTS TO CROSS BUT WITHOUT SUCCESS. THE ORSIRO WAS INSERTED THROUGH A GUIDE EXTENSION AND WHILE TRYING TO CROSS THE LESION THE STENT CAME OFF THE BALLOON. LOT NUMBER UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10925445 ↗
• MalfunctionNov 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A DISSECTION IN THE LAD. THE STENT DISLODGED FROM BALLOON DURING PREPARATION. ANOTHER ORSIRO WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10853804 ↗
• MalfunctionAug 18, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT WAS CHOSEN FOR TREATMENT. WHEN THE ORSIRO WAS REMOVED FROM PACKAGING, IT WAS NOTICED THAT THE TIP WAS DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10422820 ↗
• MalfunctionJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSRIO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. WHEN REMOVING THE STYLET THERE WAS NO STENT MOUNTED ONTO THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10353570 ↗
• MalfunctionJul 22, 2020Deflation Problem; Deflation Problem

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION AND STENT DEPLOYMENT THE DEFLATION TIME OF THE BALLOON TOOK LONGER THAN USUAL, APPROXIMATELY 10 SECONDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311856 ↗
• MalfunctionJul 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. UPON REMOVING THE CATHETER FROM THE HOOP IT WAS REALIZED THAT THE STENT WAS NOT CRIMPED ON THE BALLOON. THE STENT WAS FOUND INSIDE OF THE HOOP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10311709 ↗
• MalfunctionJun 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A BYPASS. DURING THE PROCEDURE THE STENT GOT STUCK AND DISLODGED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194692 ↗
• MalfunctionMay 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING PREPARATION IT WAS NOTICED THAT NO STENT WAS ON THE BALLOON. THE DEVICE WAS NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10040164 ↗
• MalfunctionApr 10, 2020Fracture; Fracture

  AN ORSIO DRUG-ELUTING STENTS SYSTEM WAS SELECTED FOR TREATMENT OF THE RCA. DURING PROCEDURE THE HYPOTUBE FRACTURED APPROX. 5 INCHES FROM PROXIMAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9949275 ↗
• MalfunctionMar 6, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS VESSEL. AFTER PRE-DILATATION THE ORSIRO WAS INSERTED BUT STRONG RESISTANCE WAS FELT. THUS IT WAS REMOVED FROM THE PATIENTS BODY AND A STENT DEFORMATION WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9800598 ↗
• InjuryDec 20, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE ORSIRO WAS INITIALLY DEPLOYED IN THE DISTAL RCA DUE TO AN IN-STENT RESTENOSIS DURING THE INDEX PROCEDURE ON (B)(6) 2016. ON (B)(6) 2019 THE PATIENT RETURNED WITH SYMPTOMS, AN ANGIO WAS DONE AND AN IN-STENT THROMBOSIS DETECTED.

  Patient problems: Thrombosis

  MAUDE report 9504159 ↗
• MalfunctionOct 30, 2019Difficult to Remove; Difficult to Remove

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A STENOSIS IN THE MID LAD . THE STENT WAS SUCCESSFULLY DEPLOYED. DURING REMOVAL OF THE DEVICE RESISTANCE WAS NOTED AND THE USED GUIDING CATHETER HAS SHIFTED TO THE LEFT MAIN ARTERY. THE LOT NUMBER OF THIS DEVICE IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9258005 ↗
• MalfunctionAug 21, 2019Inflation Problem; Inflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. WHEN INFLATING THE DEVICE THERE WAS NO RESPONSE FROM THE BALLOON. TO ENSURE THAT THE INFLATION DEVICE WAS NOT DEFECT, IT WAS EXCHANGED FOR A NEW ONE BUT STILL DID NOT WORK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8916237 ↗
• MalfunctionAug 6, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A LESION IN A RCA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8866657 ↗
• MalfunctionJul 15, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE ORSIRO COULD NOT PASS THE LESION AND THE STENT WAS DEFORMED. AFTER WITHDRAWAL THE STENT DISLODGED FINALLY FROM THE BALLOON OUTSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8791649 ↗