Orsiro 3.0/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07640130438996), received between Apr 22, 2019 and Oct 3, 2022 — classified as 1 injury, 20 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE ORSIRO WAS INSERTED INTO THE PATIENTS BODY, NOT KNOWING THAT THE STENT WAS NOT ON THE BALLOON, BUT HAD FALLEN OFF ON THE BACK TABLE BEFORE INSERTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15528419 ↗
• MalfunctionJul 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER REMOVING THE STYLET, IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON. ANOTHER STENT WAS SELECTED AND THE PROCEDURE COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12127102 ↗
• MalfunctionJun 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE LESION COULD NOT BE CROSSED WITH THE DEVICE AND WAS REMOVED FROM THE PATIENTS BODY TO BALLOON THE VESSEL AGAIN. BEFORE REINSERTING, THE DELIVERY SYSTEM WAS WIPED DOWN AND THE STENT CAME OFF THE BALLOON OUTSIDE THE PATIENTS BODY. ORIGINALLY REPORTED ON MDR-1028232-2021-02877, BUT THE LOT NUMBER WAS INCORRECT. WE HAVE CLOSED THE ORIGINAL REPORT AND OPENED THIS ONE WITH THE CORRECT LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011287 ↗
• MalfunctionMay 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE LESION COULD NOT BE CROSSED WITH THE DEVICE AND WAS REMOVED FROM THE PATIENTS BODY TO BALLOON THE VESSEL AGAIN. BEFORE REINSERTING, THE DELIVERY SYSTEM WAS WIPED DOWN AND THE STENT CAME OFF THE BALLOON OUTSIDE THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11889547 ↗
• MalfunctionJan 29, 2021Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS MID RCA. MULTIPLE ATTEMPTS WERE MADE TO CROSS A PREVIOUSLY IMPLANTED STENT. AFTER PULLING THE DEVICE OUT IT WAS DETECTED THAT STRUTS ON THE STENT WERE DAMAGED. A 6 F GUIDELINER WAS USED DURING PROCEDURE. THIS WAS THE FIRST OF TWO ORSIRO STENTS THAT FAILED IN THIS CASE. THE SECOND DEVICE IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11255147 ↗
• MalfunctionJan 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN A MODERATELY TORTUOUS MID RCA. A 2ND ORSIRO WAS INTRODUCED. AFTER MULTIPLE ATTEMPTS TO CROSS THE LESION THE STENT WAS REMOVED AND WHILE WIPING DOWN THE CATHETER IT WAS NOTICED THAT THE STENT HAD SLIPPED OFF THE BALLOON. IT WAS STILL ON THE DISTAL PORTION OF THE CATHETER. A 6 F GUIDELINER WAS USED DURING PROCEDURE. THE FIRST SECOND DEVICE IS REPORTED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11255140 ↗
• MalfunctionOct 19, 2020Device 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 A MODERATELY TORTUOUS RCA. THE LESION WAS PARTIALLY CROSSED BUT THE STENT DISLODGED FROM THE BALLOON DURING THE ATTEMPT TO WITHDRAW THE CATHETER. THE BALLOON WAS USED TO ADAPT THE STENT AGAINST THE VESSEL WALL AND ANOTHER ORSIRO WAS USED TO COVER THE ADAPTED STENT AND LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10701676 ↗
• MalfunctionFeb 24, 2020Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER OPENING THE PACKAGE, IT WAS NOTICED THAT THE STENT WAS DAMAGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745999 ↗
• MalfunctionFeb 3, 2020Inflation Problem; Inflation Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT OF A CALCIFIED LESION IN THE DISTAL RCA. AFTER PLACING THE STENT IN THE TARGET LESION, THE BALLOON COULD NOT BE INFLATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9662497 ↗
• MalfunctionAug 21, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING UNPACKING THE ORSIRO STENT DISLODGED FROM THE BALLOON AND STAYED INSIDE THE PROTECTOR. THE DEVICE WAS NOT USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915688 ↗
• InjuryAug 12, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A LESION (100 PERCENT STENOSIS DEGREE) IN A RCA. 15 TO 30 MINUTES AFTER IMPLANTATION ST ELEVATION WAS OBSERVED. A STENT THROMBOSIS HAS OCCURRED.

  Patient problems: Thrombosis

  MAUDE report 8885932 ↗
• MalfunctionJul 30, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. THE TARGET LESION COULD NOT BE CROSSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841955 ↗
• MalfunctionJul 30, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN A CX. DESPITE PRE-DILATATION IT WAS NOT POSSIBLE TO CROSS THE LESION WITH THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841949 ↗
• MalfunctionJul 30, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE DEVICE WAS INTRODUCED THROUGH A GUIDELINER BUT THE CALCIFIED TARGET LESION COULD NOT BE CROSSED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841935 ↗
• MalfunctionJul 24, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION. DESPITE PRE-DILATATION THE DEVICE DID NOT CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823245 ↗
• MalfunctionJul 3, 2019Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION IN A TORTUOUS LAD. WHEN CROSSING A PREVIOUSLY IMPLANTED STENT, DEVICE COULD NOT BE ADVANCED. THEN A GUIDEZILLA WAS USED AND THE STENT COULD BE ADVANCED. AFTER REMOVAL IT WAS DETECTED THAT THE STENT WAS STILL ON THE SYSTEM BUT DISTALLY DISPLACED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8760371 ↗
• MalfunctionJul 1, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM COULD NOT PASS THE SEVERELY CALCIFIED AND TORTUOUS LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8750631 ↗
• MalfunctionJun 19, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (99% STENOSIS DEGREE) IN AN TORTUOUS CX. THE DEVICE WAS UNABLE TO CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8712180 ↗
• MalfunctionJun 17, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION IN A BYPASS. DESPITE PRE-DILATATION THE DEVICE DID NOT CROSS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8703455 ↗
• MalfunctionMay 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE THE STENT DISLODGED FROM THE BALLOON. THEREFORE THE INTACT STENT WAS REMOVED FROM THE PATIENT'S BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8640409 ↗
• MalfunctionApr 22, 2019Fracture; Fracture

  OUS MDR - AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AS IT WAS DIFFICULT TO CONNECT THE ORSIRO STENT SYSTEM WITH AN INDEFLATOR THE STENT WAS VISIBLY CHECKED AND A CRACK AT THE HUB WAS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8537291 ↗