Orsiro Mission 3.5/15/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07640130455979), received between Dec 15, 2021 and Jul 22, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE PROXIMAL LCX. AFTER PRE-DILATION, THE AFFECTED DEVICE WAS INTRODUCED BY USE OF A 6F GUIDELINER GUIDING EXTENSION CATHETER BUT FAILED TO CROSS THE LESION. DURING WITHDRAWAL INTO THE GUIDING EXTENSION CATHETER, THE STENT DISLODGED FROM THE DELIVERY SYSTEM. THE DELIVERY SYSTEM WAS WITHDRAWN FROM THE PATIENT TOGETHER WITH THE GUIDING EXTENSION CATHETER AND THE GUIDING CATHETER AS ONE UNIT. THE TARGET LESION WAS TREATED WITH A 3.5/18 ORSIRO MISSION. BOTH THE COMPLAINT DEVICE AND THE STENT WERE DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22562918 ↗
• MalfunctionJul 10, 2025Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A VAIN GRAFT. THE DEVICE COULD NOT CROSS. GUIDE AND STENT CATHETER WERE WITHDRAWN. THE STENT SHIFTED INTO THE DESCENDING AORTA. AN ATTEMPT WAS MADE TO REMOVE IT WITH A SNARE, BUT THIS WAS UNSUCCESSFUL. THE PATIENT IS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22466344 ↗
• InjuryOct 16, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF THE MID CX. IMMEDIATELY AFTER PROCEDURE AN IN STENT THROMBOSIS OCCURRED. PATIENT DEVELOPED CHEST PAIN. RE-BALLOONING OF THE STENT WAS PERFORMED AND ADDITIONAL HEPARIN WAS GIVEN.

  Patient problems: Chest Pain; Thrombosis/Thrombus

  MAUDE report 20468078 ↗
• MalfunctionNov 8, 2023Failure to Advance; Failure to Advance

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN THE MODERATELY TORTUOUS MID RCA. THE STENT WOULD NOT CROSS. DURING THE PROCEDURE, WIRE/GUIDELINER/GUIDE KICKED OUT OF VESSEL AND DISSECTED THE PROXIMAL RCA, WHICH IS NOT RELATED TO THE ORSIRO MISSION AS THE SYSTEM WAS NOT ADVANCED TO THE POSITION OF THE DISSECTION. THE DISSECTED PART OF THE VESSEL WAS ONLY TREATED WITH BALLOON INFLATIONS. IT WAS STATED THE VESSEL WAS DISSECTED DUE TO THE USE OF A GUIDE EXTENSION AND POOR GUIDE CATHETER SUPPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18096738 ↗
• MalfunctionJun 15, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DESPITE PRE-DILATATION IT WAS NOT POSSIBLE TO CROSS THE LESION. DURING THE ATTEMPT TO WITHDRAW THE STENT THROUGH THE GUIDING CATHETER, IT DISLODGED FROM THE BALLOON. IT WAS DECIDED TO DILATE THE STENT IN PLACE IN THE PROXIMAL PART OF THE RCA. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17135583 ↗
• MalfunctionMay 1, 2023Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION IN THE LAD. THE LESION WAS PRE-TREATED WITH SHOCKWAVE. THE ORSIRO MISSION WOULD NOT CROSS THE LESION, AND THE STENT FELL OFF BALLOON WHEN REMOVING THE DEVICE. ANOTHER ORSIRO WAS ADVANCED TO ADAPT THE UNDEPLOYED STENT AGAINST THE VESSEL WALL. PATIENT DISCHARGED HOME WITHOUT ANY INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16848159 ↗
• MalfunctionDec 15, 2021Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (50 PERCENT STENOSIS DEGREE) IN THE PRE-DILATED MILDLY TORTUOUS MID LAD. THE STENT GOT STUCK AT THE TRANSITION POINT OF THE GUIDEZILLA EXTENSION CATHETER, AND THE STENT STRUTS WERE DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010194 ↗
• MalfunctionDec 15, 2021Material Deformation; Material Deformation

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE STENT GOT STUCK AT THE TRANSITION POINT OF THE GUIDEZILLA EXTENSION CATHETER, AND THE STENT STRUTS WERE DEFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010184 ↗