Orsiro 2.25/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 07640130439023), received between Apr 3, 2019 and Jul 5, 2022 — classified as 1 injury, 42 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (18 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 5, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  THE SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS LAD WAS TREATED WITH AN WOLVERINE CUTTING BALLOON. AFTERWARDS, IT WAS ATTEMPTED TO PLACE THE ORSIRO DRUG-ELUTING STENT SYSTEM, BUT THE LESION COULD NOT BE PASSED. THEREFORE, A GUIDEPLUS EL EXTENSION CATHETER WAS USED TO BRING THE ORSIRO TO THE FRONT OF THE LESION. IT WAS TRIED TO PLACE THE ORSIRO BUT THE STENT WAS STILL ON THE BALLOON BUT SLIGHTLY OUT OF PLACE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14919638 ↗
• MalfunctionJun 2, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE SEVERELY TORTUOUS RCA. THE PRE-DILATED LESION COULD NOT BE CROSSED WITH THE DEVICE DESPITE SEVERAL ATTEMPTS. RESISTANCE WAS FELT WHILE ADVANCING. THE DEVICE WAS REMOVED, AND A STENT DEFORMATION WAS DETECTED. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579657 ↗
• MalfunctionMay 12, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF IRS LESION WITH 80 PERCENT STENOSIS DEGREE IN THE LAD. WHEN TRYING TO CROSS THE LESION IN THE LAD, THE STENT GOT DEFORMED AT THE DISTAL END. ANOTHER DEVICE WAS USED TO COMPLETE THE INTERVENTION SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14380170 ↗
• MalfunctionMay 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A COMPLEX LCX - PROXIMAL DIAGONAL VESSEL. DESPITE PRE-DILATATION IT WAS NOT POSSIBLE TO PASS THE ORSIRO THROUGH THE SEVERELY CALCIFIED LESION. THE STENT DELIVERY SYSTEM WAS WITHDRAWN TWICE. UPON WITHDRAWAL, ON ATTEMPT TO RE-INSERT THE DEVICE, IT WAS NOTICED THAT THE STENT HAS BEEN DISLODGED FROM THE BALLOON. HOWEVER, IT WAS NOT POSSIBLE TO LOCATE THE DISLODGED STENT INSIDE OR OUTSIDE THE PATIENTS BODY. THE DELIVERY SYSTEM WAS DISCARDED AT THE HOSPITAL AND IS THEREFORE NOT AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14278547 ↗
• MalfunctionJan 18, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT CAME OFF THE DELIVERY SYSTEM WHILE PREPARING FOR IMPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13282738 ↗
• MalfunctionJan 5, 2022Failure to Advance; Failure to Advance

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE). THE ORSIRO STENT SYSTEM COULD NOT CROSS THE LESION IN THE SEVERE TORTUOUS DIAGONAL. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167960 ↗
• MalfunctionDec 29, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. WHILE INTRODUCING THE STENT INTO THE GUIDING CATHETER, RESISTANCE WAS FELT. SUBSEQUENTLY, THE DEVICE WAS WITHDRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13112604 ↗
• MalfunctionDec 15, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (98 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL CX. AFTER PRE-DILATATION, THE ATTEMPT TO DELIVER THE STENT WAS UNSUCCESSFUL. WHEN THE DEVICE WAS REMOVED, THE PROXIMAL PART OF THE STENT WAS DAMAGED. ORIGINALLY REPORTED ON MDR-1028232-2021-06682, BUT ASSET, MODEL NAME AND MODEL NUMBER WERE INCORRECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014552 ↗
• MalfunctionDec 10, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (98 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL CX. AFTER PRE-DILATATION, THE ATTEMPT TO DELIVER THE STENT WAS UNSUCCESSFUL. WHEN THE DEVICE WAS REMOVED, THE PROXIMAL PART OF THE STENT WAS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12975404 ↗
• MalfunctionNov 18, 2021Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ORSIRO STENT SYSTEM COULD NOT CROSS THE MODERATE CALCIFIED LESION (50 PERCENT STENOSIS DEGREE) IN THE MEDIAL LCX.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12838057 ↗
• MalfunctionNov 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT A LESION WITH 90 PERCENT STENOSIS DEGREE IN THE RCA. AFTER PRE-DILATATION OF THE LESION, DURING LESION CROSSING RESISTANCE WAS FELT, THUS IT WAS DECIDED TO REMOVE THE ORSIRO. UPON REMOVAL THE STENT DISLODGED FROM THE BALLOON. THE STENT WAS CRUSHED AGAINST THE VESSEL WALL CLOSE TO THE TARGET LESION BY USING ANOTHER STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12752122 ↗
• MalfunctionOct 20, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING IT WAS NOTICED THAT THE STENT WAS DEFORMED AT ITS PROXIMAL PART. ANOTHER ORSIRO OF SAME SIZE WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12664597 ↗
• MalfunctionAug 10, 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 DISTAL LAD. THE ORSIRO WAS ABLE TO ONLY ADVANCE TO THE FIRST THIRD OF THE LESION AND WAS UNABLE TO CROSS THE REMAINING TWO THIRDS. IT WAS DECIDED TO USE A SUPPORT CATHETER TO ASSIST THE ORSIRO IN CROSSING. UPON WITHDRAWING THE ORSIRO FROM THE FRONT THIRD OF THE LESION AND WHILE STILL IN THE LAD, THE STENT SLID OFF OF THE BALLOON, REMAINED IN THE LAD BUT WAS FULLY EXPANDED. IT WAS POSSIBLE TO WORK THROUGH THE EXPANDED ORSIRO TO TREAT THE REMAINING LESION WITH A COMPETITORS STENT. THE RESULTS WERE GOOD AND THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12305060 ↗
• MalfunctionJul 13, 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 SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS LAD. AFTER PREPARATION WITH ROTABLATOR AND PRE-DILATATION, THE ORSIRO WAS DELIVERED BUT COULD NOT CROSS THE LESION. DURING WITHDRAWAL THE STENT DISLODGED AND WAS RETRIEVED WITH A SNARE. THE PROCEDURE WAS CONTINUED WITH A COMPETITORS STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12158864 ↗
• MalfunctionMar 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE RCA. AFTER THE ORSIRO PASSED THE GC, THERE WAS A CALCIFICATION AT THE OSTIAL RCA. TO AVOID A STENT DISLODGEMENT, THE PHYSICIAN REMOVED THE ORSIRO AND NOTICED THAT THE STENT WAS ALREADY OFF THE DELIVERY SYSTEM AND REMAINED IN THE CORONARY VESSEL. THE DISLODGED STENT WAS REMOVED BY USING A BALLOON CATHETER. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11453961 ↗
• MalfunctionMar 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS PROXIMAL CX. DURING PREPARATION THE STENT DISLODGED FROM THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404974 ↗
• MalfunctionJan 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION IN A MODERATELY TORTUOUS RCA. THE STENT DISLODGED DURING CROSSING OF THE LESION. THE DISLODGED STENT WAS ADAPTED TO THE VESSEL WALL WITH ANOTHER STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11125745 ↗
• MalfunctionNov 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A SEVERELY TORTUOUS MID CX. WHILE IT WAS ATTEMPTED TO PLACE THE STENT AT THE DESIRED LOCATION IT DISLODGED FROM THE BALLOON. THE DISLODGED STENT WAS DEPLOYED BY USING A BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10853797 ↗
• MalfunctionNov 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (80 PERCENT STENOSIS DEGREE). WHEN TRYING TO INSERT THE STENT SYSTEM INTO THE PATIENT PATIENTS BODY IT WAS NOTICED THE STENT WAS LOOSE ON THE BALLOON. THE SYSTEM WAS NO LONGER USED AND ANOTHER STENT WAS IMPLANTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10769535 ↗
• MalfunctionOct 15, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. IT WAS NOT POSSIBLE TO CROSS PREVIOUSLY IMPLANTED STENTS AND A STENT DEFORMATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10686648 ↗
• MalfunctionSep 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS LAD. DURING ATTEMPT TO DELIVER THE DEVICE RESISTANCE WAS FELT. THE DEVICE WAS REMOVED, FURTHER DILATATION DONE AND DELIVERED AGAIN. RESISTANCE WAS FELT IN THE 5.5 F GUIDELINER AND THE DEVICE WAS REMOVED AGAIN. A STENT DISLODGEMENT WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10484027 ↗
• MalfunctionSep 1, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. AFTER PRE DILATATION THE DEVICE WAS DELIVERED TO THE LESION, BUT RESISTANCE WAS FELT PROXIMAL TO THE LESION. THEREFORE, THE DEVICE WAS REMOVED FROM PATIENT AND IT WAS NOTICED THAT THE STENT WAS DEFORMED AT ITS DISTAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10479514 ↗
• InjuryAug 26, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING IMPLANTATION THE STENT DISLODGED IN THE AORTA. PATIENT WAS TRANSFERRED TO AN EMERGENCY ROOM.

  Patient problems: Injury; No Information

  MAUDE report 10456671 ↗
• MalfunctionJul 22, 2020Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. UPON PRE-DILATATION OF THE SEVERELY CALCIFIED LESION IN THE LAD THE ORSIRO COULD NOT PASS. THUS IT WAS REMOVED FROM THE LESION AND THE PROCEDURE WAS FINISHED WITH ANOTHER STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10310842 ↗
• MalfunctionJun 16, 2020Difficult to Remove; Difficult to Remove

  THE ORSIRO US DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A LESION IN THE DISTAL LCX. AFTER SUCCESSFUL STENT DEPLOYMENT IT WAS DIFFICULT TO REMOVE THE ORSIRO US DELIVERY BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10159164 ↗