Orsiro 3.5/35/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07640130439399), received between May 8, 2019 and Aug 24, 2021 — classified as 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS LAD. IT WAS TRIED TO DELIVER THE DEVICE BUT THE ORSIRO DID NOT CROSS THE LESION. ONCE IT WAS REMOVED FROM THE PATIENTS BODY AND CHECKED IT, IT WAS FOUND THAT STENT WAS CURLED UP AT THE TIP EDGE. THIS WAS ORIGINALLY REPORTED ON MDR-1028232-2021-04066, BUT THE DEVICE LOT NUMBER WAS INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12358940 ↗
• InjuryAug 17, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2021, THE PATIENT ADMITTED WITH ST ELEVATED AMI (DISTAL RCA) AND SUCCESSFULLY TREATED WITH ORSIRO DES (TIMI III FLOW POST-OPERATIVE). DAPT WAS INITIATED. 6 DAYS LATER, PATIENT DEVELOPED BRADYCARDIA AND AVB. DURING CONTROL ANGIOGRAPHY A TOTAL OCCLUSION WAS OBSERVED PROXIMAL TO THE STENT. POBA WAS DONE AND DAPT MEDICATION WAS CHANGED, AND THE PATIENT WAS DISCHARGED. 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 12334284 ↗
• MalfunctionAug 17, 2021Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION. IT WAS NOT POSSIBLE TO CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12333457 ↗
• MalfunctionJul 20, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS LAD. IT WAS TRIED TO DELIVER THE DEVICE BUT THE ORSIRO DID NOT CROSS THE LESION. ONCE IT WAS REMOVED FROM THE PATIENTS BODY AND CHECKED IT, IT WAS FOUND THAT STENT WAS CURLED UP AT THE TIP EDGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196887 ↗
• MalfunctionApr 8, 2021Deflation Problem; Deflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED LESION (75 PERCENT STENOSIS DEGREE) IN THE RCA. AFTER STENT IMPLANTATION IT WAS NOTICED THAT THE DEFLATION TIME WAS LONGER THAN USUAL (MORE THAN 15 SECONDS, NORMALLY 10 SECONDS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11633475 ↗
• MalfunctionMar 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. BEFORE DEVICE INSERTION IT WAS NOTICED THAT THE STENT HAS BEEN DISLODGED FROM THE DELIVERY BALLOON AND THE STENT WAS FOUND ON THE DRAPE. ANOTHER STENT WAS USED FOR INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404971 ↗
• MalfunctionMar 3, 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 (80 PERCENT STENOSIS DEGREE IN A MILDLY TORTUOUS RCA. THE ORSIRO COULD NOT PASS THE PRE-DILATED LESION AND A DEFORMATION OF THE STENT WAS NOTICED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404955 ↗
• MalfunctionJan 25, 2021Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS LEFT CORONARY ARTERY. THE LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11227627 ↗
• MalfunctionJan 4, 2021Material Deformation; Material Deformation

  IT WAS INTENDED TO TREAT A LESION (90 PERCENT STENOSIS DEGREE, LESION LENGTH 35 MM, VESSEL REFERENCE DIAMETER 3.5 MM) IN THE LAD#6 WITH THE ORSIRO DRUG-ELUTING STENT SYSTEM. AFTER PRE-DILATATION THE PHYSICIAN UTILIZED A HIKYAKU KANEKA EXTENSION CATHETER AND ATTEMPTED TO INTRODUCE THE ORSIRO INTO THE PATIENTS BODY. HOWEVER, DESPITE SEVERAL ATTEMPTS THE COMPLAINT INSTRUMENT DID NOT PASS THE EXTENSION CATHETER. UPON REMOVAL OF THE COMPLAINT INSTRUMENT A STENT DEFORMATION WAS NOTED. THE PROCEDURE WAS CONTINUED WITH A NEW EXTENSION CATHETER AND A NEW STENT SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11113486 ↗
• 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 10311729 ↗
• MalfunctionJul 1, 2020Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ORSIRO COULD NOT PASS A PREVIOUSLY IMPLANTED STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10218368 ↗
• InjuryJun 24, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF HIGH STENOSIS LESION IN THE RCA. 7.5 WEEKS AFTER PRIMARY INTERVENTION THE PATIENT FELL WHILE WORKING AND WAS TRANSFERRED TO HOSPITAL. A STENT THROMBOSIS WAS DETECTED. PCI WAS DONE. IT WAS STATED BY THE PHYSICIAN THAT ANTIPLATELET THERAPY MIGHT NOT HAVE BEEN EFFECTIVE AND THEREFORE MEDICATION WAS CHANGED. 5.5 WEEKS LATER AGAIN A THROMBOSIS WAS DETECTED DURING FOLLOW-UP EXAMINATION. SINCE THE CHANGE OF ANTIPLATELET MEDICATION DID NOT SHOW THE EXPECTED RESULT IT WAS STATED THAT IT MIGHT BE A PATIENT RELATED ISSUE.

  Patient problems: Thrombosis

  MAUDE report 10188490 ↗
• MalfunctionMay 13, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A CALCIFIED LESION IN THE RCA. AFTER PRE-DILATATION THE ORSIRO WAS DELIVERED INTO THE TARGET LESION BUT RESISTANCE WAS FELT. UPON REMOVAL A GUIDEPLUS WAS INSERTED AND THE ORSIRO WAS RE-INSERTED BUT THERE WAS STILL SOME RESISTANCE. THUS THE ORSIRO WAS REMOVED FROM THE PATIENTS BODY AND A STENT DEFORMATION WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10051161 ↗
• MalfunctionMar 17, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN A MODERATE TORTUOUS PROXIMAL LAD. DESPITE PRE-DILATATION THE LESION COULD NOT BE CROSSED WITH THE DEVICE. IT WAS DETECTED THAT A STENT DEFORMATION HAS OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9838834 ↗
• MalfunctionMar 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING PREPARATION IT WAS NOTICED THAT THERE WAS NO STENT ON THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9793227 ↗
• MalfunctionFeb 26, 2020Deflation Problem; Deflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (87 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS VESSEL. AFTER DEPLOYMENT OF THE STENT THE BALLOON WAS DEFLATED BUT THE DEFLATION TIME WAS TOO LONG.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9757281 ↗
• MalfunctionJan 13, 2020Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A SEVERELY CALCIFIED AND TORTUOUS LESION. DESPITE PRE-DILATATION THE TARGET LESION COULD NOT BE CROSSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583768 ↗
• MalfunctionOct 16, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT WAS CHOSEN TO TREAT A LONG SEVERELY CALCIFIED LESION (92 PERCENT STENOSIS DEGREE, 34MM LESION LENGTH) IN THE SEVERELY TORTUOUS RCA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. DURING WITHDRAWAL THE STENT DISLODGED FROM THE DELIVERY SYSTEM. AN ATTEMPT TO RETRIEVE THE STENT WAS UNSUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9199731 ↗
• MalfunctionJul 9, 2019Material Rupture; Material Rupture

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE THE ORSIRO WAS INFLATED TWICE UP TO 16 BAR. AT THE THIRD INFLATION THE ORSIRO STENT BALLOON RUPTURED AT 16 BAR. IVUS CONFIRMED THAT THE STENT WAS SUCCESSFULLY IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8774218 ↗
• MalfunctionJun 11, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION IN A RCA. IN THE PROCEDURE ALSO A GUIDEPLUS WAS USED. WHILE INSERTING THE ORSIRO RESISTANCE WAS FELT BUT WAS DELIVERED FURTHER. IT SEEMED THAT THE STENT DISLODGED WHILE PASSING THE DISTAL END OF THE GUIDEPLUS. AFTER REMOVAL, THE STENT WAS STILL ON THE DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8689237 ↗
• MalfunctionMay 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT, BUT DID NOT CROSS THE LONG CALCIFIED LESION, STENOSIS DEGREE 80%.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591022 ↗