Orsiro 2.75/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 07640130439047), received between Apr 3, 2019 and Jun 8, 2022 — classified as 1 injury, 21 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 8, 2022Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (70 PERCENT STENOSIS DEGREE) IN THE MID CX. AFTER PRE-DILATATION IT WAS NOT POSSIBLE TO ADVANCE THE STENT. ANOTHER PRE-DILATATION WAS PERFORMED, AND THE DEVICE WAS RE-INSERTED BUT A DEFORMATION WAS NOTICED AND THE WHOLE SYSTEM WAS REMOVED WITH DIFFICULTIES FROM THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14634564 ↗
• MalfunctionDec 21, 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 MODERATELY TORTUOUS LAD. DURING DELIVERY OF THE DEVICE, THE STENT WAS DISLODGED. THE ORSIRO WAS NOT RETRIEVED, BUT A BALLOON CATHETER WAS PLACED INSIDE THE STENT, AND DILATATION WAS PERFORMED AT THE PLACE WHERE THE STENT WAS DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13056503 ↗
• MalfunctionNov 11, 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 MID LAD. DESPITE PRE-DILATATION, THE DEVICE COULD NOT PASS THE LESION AND WAS REMOVED. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12796419 ↗
• MalfunctionOct 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THERE WAS NO STENT ON THE BALLOON. IT WAS DETECTED OUTSIDE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579834 ↗
• MalfunctionSep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF LESION (80 PERCENT STENOSIS DEGREE) IN THE MODERATELY TORTUOUS PROXIMAL LAD. WHILE ADVANCING THE DEVICE, RESISTANCE WAS FELT AND IT WAS DECIDED TO REMOVE THE ORSIRO STENT SYSTEM. AFTER REMOVAL IT WAS NOTICED THAT THE STENT HAS BEEN DISLODGED INSIDE THE PATIENT. EVENTUALLY, IT WAS REMOVED BY USING A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12445595 ↗
• MalfunctionJul 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. AFTER PREPARATION DURING PROCEDURE IT WAS DETECTED THAT NO STENT WAS ON THE BALLOON. THE STENT WAS FOUND OUTSIDE ON THE STERILE FIELD NEXT TO THE Y-CONNECTOR. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12145684 ↗
• MalfunctionJun 24, 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 A SEVERELY TORTUOUS PROXIMAL LCX. THE STENT DISLODGED PROXIMAL TO THE LESION AND WAS ADAPTED THERE TO THE VESSEL WALL WITH A BALLOON. LOT NUMBER UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12058281 ↗
• MalfunctionMay 26, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889530 ↗
• InjuryMay 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  THREE ORSIRO DRUG-ELUTING STENT SYSTEMS WERE SELECTED FOR TREATMENT OF A LESION (80-90 PERCENT STENOSIS DEGREE) IN THE DISTAL RCA/OM. ON (B)(6) 2021 THE LESION WAS TREATED AMONGST OTHERS WITH AN ORSIRO 2.75/18 WITH GOOD RESULTS. THE NEXT DAY THE PATIENT WENT INTO VASOVAGAL ATTACK WITH BRADYCARDIA AND HYPOTENSION. A CONTROL PCI WAS CONDUCTED AND MULTIPLE THROMBOSIS WERE DETECTED. SEVERAL ASPIRATIONS WERE DONE WITH VERY GOOD RESULT. AN INTRAAORTIC BALLOON PUMP (IABP) WAS IMPLANTED. THE OTHER TWO ORSIRO STENTS ARE REPORTED SEPARATELY.

  Patient problems: Bradycardia; Thrombosis/Thrombus

  MAUDE report 11848277 ↗
• 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 (85 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS DISTAL LAD. THE STENT COULD NOT PASS THE LESION AND A DEFORMATION WAS DETECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803321 ↗
• MalfunctionApr 27, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. STENT PLATFORM LOOKED UNRAVELED PRIOR TO IMPLANTING DEVICE IN THE PATIENT. PRODUCT WAS NEVER IMPLANTED OR ATTEMPTED TO IMPLANT IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11735275 ↗
• MalfunctionFeb 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT. WHILE IT WAS ATTEMPTED TO CROSS THE TARGET LESION RESISTANCE WAS FELT. DURING WITHDRAWAL THE STENT DISLODGED AND WAS ADAPTED TO THE VESSEL WALL WITH ANOTHER STENT. THE PROCEDURE WAS FINISHED WITHOUT ANY SIDE EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11279516 ↗
• MalfunctionJan 21, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A PRE-DILATED LESION IN THE MILDLY TORTUOUS PROXIMAL CX. THE ORSIRO GOT CAUGHT INSIDE THE ARTERY AND AFTER REMOVAL IT WAS NOTICED THAT THE STENT WAS DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207382 ↗
• MalfunctionJan 7, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN A SEVERELY TORTUOUS MID LAD. DESPITE PRE-DILATATION THE DEVICE COULD NOT PASS THE LESION AND A DEFORMATION HAD OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11135695 ↗
• MalfunctionJul 31, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSRIO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A PROXIMAL SEVERELY TORTUOUS RCA. AFTER PRE-DILATATION WHILE ADVANCING THE DEVICE THROUGH LESION, THE STENT DISLODGED. THE STENT COULD NOT BE FOUND IN PATIENTS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10353476 ↗
• MalfunctionJan 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED PREDILATED LESION IN A MODERATELY TORTUOUS RCA. THE LESION COULD NOT BE CROSSED WITH THE DEVICE. AFTER REMOVAL IT WAS DETECTED THAT THE STENT WAS NOT ON THE BALLOON ANYMORE. STENT COULD NOT BE FOUND, NEITHER INSIDE NOR OUTSIDE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9607190 ↗
• MalfunctionDec 20, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE SEVERE CALCIFIED, PRE-DILATED LESION COULD NOT BE CROSSED WITH THE DEVICE. A GUIDEZILLA WAS USED DURING PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9504318 ↗
• MalfunctionOct 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING DEVICE INTRODUCTION INTO THE Y-CONNECTOR THE ORSIRO STENT DISLODGED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9167832 ↗
• MalfunctionMay 9, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  OUS MDR - AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A CALCIFIED CORONARY LESION. IT WAS REPORTED THAT THE STENT DISLODGED AND WAS DETECTED AT THE LEVEL OF THE VALVE OF THE USED INTRODUCER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8597374 ↗
• MalfunctionMay 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  OUS MDR - AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A MODERATELY CALCIFIED LESION IN THE TORTUOUS RCA. THE ORSIRO STENT COULD NOT PASS THE LESION AND DURING THE ATTEMPT TO PUSH IT THROUGH THE LESION THE STENT DISLODGED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591010 ↗
• MalfunctionMay 3, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS A PREVIOUSLY IMPLANTED STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8580070 ↗
• MalfunctionApr 3, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  OUS MDR - THE DRUG ELUTING STENT SYSTEM ORSIRO WAS CHOSEN FOR THE INTERVENTION. THE STENT DISLODGED FROM THE BALLOON OUTSIDE OF THE PATIENT'S BODY DURING PREPARATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8480715 ↗