Orsiro 2.25/22/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 07640130439085), received between Apr 3, 2019 and Jun 2, 2022 — classified as 34 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2022Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING IT WAS NOTICED THAT THE STENT WAS DEFORMED. ANOTHER STENT WAS USED TO FINISH THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14579604 ↗
• MalfunctionMar 9, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE OM LESION. DURING ADVANCING THE DEVICE, THE STENT DISLODGED INSIDE THE LEFT MAIN ARTERY. THE STENT WAS RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13704225 ↗
• MalfunctionJan 5, 2022Failure to Advance; Failure to Advance

  AN ORSIRO DRUG ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (85 PERCENT STENOSIS DEGREE) IN THE MIDDLE OF A MODERATELY TORTUOUS UNKNOWN VESSEL. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. THE DEVICE WAS WITHDRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13167951 ↗
• MalfunctionJul 7, 2021Material Rupture; Device Dislodged or Dislocated; Material Rupture; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS DISTAL LAD. AFTER PREDILATATION THE DEVICE WAS ADVANCED TO THE LESION. WHEN THE BALLOON WAS INFLATED WITH NOMINAL PRESSURE, THE PRESSURE DID NOT RISE AND BLOOD WAS ALSO OBSERVED, SO IT WAS JUDGED THAT THE BALLOON WAS RUPTURED AND THE CATHETER WAS REMOVED. DURING WITHDRAWAL THE STENT HAS DISLODGED AND REMAINED IN THE CORONARY ARTERY AS CONFIRMED BY ANGIOGRAPHY. RECOVERY BY SNARE WAS CONSIDERED, BUT SINCE THE STENT HAD MOVED SLIGHTLY TO DISTAL, IT WAS ADAPTED TO THE VESSEL WALL. A GUIDEPLUS EXTENSION CATHETER WAS USED DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127096 ↗
• MalfunctionMay 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE RCA. AS IT WAS ATTEMPTED TO DELIVER THE ORSIRO TO THE TARGET LESION, THE STENT GOT CAUGHT BEFORE AND DISLODGED FROM THE DELIVERY BALLOON. USING ANOTHER BALLOON CATHETER THE DISLODGED STENT WAS INFLATED AND IMPLANTED WHERE IT DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806258 ↗
• MalfunctionMar 11, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. UPON REMOVAL OF THE STYLET A DEFORMATION WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11467108 ↗
• MalfunctionMar 3, 2021Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE DISTAL RCA. THE PRE-DILATED LESION COULD NOT BE CROSSED WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11404957 ↗
• MalfunctionJan 21, 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207385 ↗
• MalfunctionDec 12, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. IT WAS NOT POSSIBLE TO CROSS THE TARGET LESION AND UPON REMOVAL THE STENT DISLODGED FROM THE BALLOON OUTSIDE THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10996452 ↗
• MalfunctionNov 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE DISTAL CX. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. DURING WITHDRAWAL THE DISTAL EDGE OF THE STENT FLARED OFF THE BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10853774 ↗
• MalfunctionOct 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE). THE PRE-DILATED LESION COULD NOT BE CROSSED. DURING WITHDRAWAL THE STENT DISLODGED INSIDE THE GUIDING CATHETER. ALL PARTS INCL. GUIDING CATHETER WERE REMOVED FROM PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10613611 ↗
• MalfunctionJul 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AS IT WAS NOTED THAT THE STENT WAS NOT VISIBLE ON THE ANGIOGRAPHY THE DEVICE WAS REMOVED AND THERE WAS NO STENT ON THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273524 ↗
• MalfunctionJul 1, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING UNPACKING RESISTANCE WAS FELT AND A DEFORMATION WAS DETECTED AT THE PROXIMAL END OF THE STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10219938 ↗
• MalfunctionJun 26, 2020Fracture; Fracture

  AN ORSIRO DRUG-ELUTING SENT SYSTEM WAS CHOSEN FOR TREATMENT OF A SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS LAD. WHEN THE ORSIRO WAS INTRODUCED INTO PATIENT AND BEFORE CONNECTING TO THE INFLATION DEVICE IT WAS DETECTED THAT THE HUB WAS CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10202576 ↗
• MalfunctionJun 25, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION IN THE RIVA. UPON STENT DEPLOYMENT AND DEVICE WITHDRAWAL IT WAS NOTICED THAT THE STENT HAS BEEN DISLODGED FROM THE DELIVERY BALLOON AND STAYED ON THE GUIDEWIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10194697 ↗
• MalfunctionJun 19, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A MODERATE CALCIFIED LESION IN THE RCA. AFTER PRE-DILATATION THE ORSIRO WAS DELIVERED INTO THE LESION BUT RESISTANCE WAS FELT. THUS THE DEVICE WAS REMOVED FROM THE BODY AND A STENT DEFORMATION WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176806 ↗
• MalfunctionMay 20, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE COULD NOT BE ADVANCED, STRUTS WERE DEFORMED. ANOTHER STENT WAS IMPLANTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10077244 ↗
• MalfunctionFeb 12, 2020Material Deformation; Material Deformation

  THE ORSIRO DRUG ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A CALCIFIED AND TORTUOUS LESION IN THE RCA. AFTER PRE-DILATATION THE ORSIRO WAS DELIVERED THROUGH THE GUIDE PLUS EXTENSION CATHETER BUT STRONG RESISTANCE WAS FELT. AFTER REMOVAL A SLIGHTLY STENT DEFORMATION WAS DETECTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9703176 ↗
• MalfunctionFeb 12, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN TORTUOUS LAD. AFTER PREPARING THE LESION WITH A ROTABLATOR, THE ORSIRO WAS INTRODUCED BUT STRONG RESISTANCE WAS NOTICED PROXIMAL AT THE LESION. AFTER REMOVAL OF THE DEVICE IT WAS DETECTED THAT THE STENT WAS DEFORMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9700344 ↗
• MalfunctionJan 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN THE RCA. THE DEVICE COULD NOT BE ADVANCED DUE TO VESSEL TORTUOSITY. A GUIDEZILLA WAS USED. DURING ADVANCING THE ORSIRO, RESISTANCE WAS FELT AND THE DEVICE WAS REMOVED. THEN, IT WAS DETECTED THAT THE STENT WAS SHIFTED TO THE SHAFT AREA.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9608058 ↗
• MalfunctionJan 20, 2020Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE RCA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. AFTER REMOVAL IT WAS DETECTED THAT THE STENT WAS DEFORMED AT THE PROXIMAL PART.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9608057 ↗
• MalfunctionJan 9, 2020Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A SEVERELY CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL LAD. AFTER PRE-DILATATION THE TARGET LESION COULD NOT BE CROSSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9569397 ↗
• MalfunctionDec 19, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING POSITIONING THE DEVICE IN THE TARGET LESION IT WAS MENTIONED THAT THE RADIOPAQUE MARKERS ARE NOT VISIBLE. AFTER REMOVAL OF THE STENT SYSTEM IT WAS DETECTED THAT THE STENT HAD MOVED TO THE PROXIMAL PART OF THE SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9497906 ↗
• MalfunctionDec 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. IT WAS REPORTED THAT THE STERILE POUCH OF THE COMPLAINT INSTRUMENT WAS FOUND OPEN DURING UNPACKING. THE DEVICE WAS RETURNED WITH THE STENT DISLODGED FROM DELIVERY SYSTEM AND LOCATED IN THE PROTECTOR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9460202 ↗
• MalfunctionNov 7, 2019Material Deformation; Material Deformation

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A CALCIFIED LESION (100 PERCENT STENOSIS DEGREE) IN A TORTUOUS RCA. AFTER PREPARING WITH A ROTABLATOR AND PRE-DILATATION THE STENT COULD NOT PASS THE LESION AND WAS THEREFORE REMOVED FROM THE PATIENTS BODY. AFTER REMOVAL A STENT DEFORMATION WAS DETECTED. A GUIDEPLUS II EL EXTENSION CATHETER WAS USED DURING THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9290600 ↗