Orsiro Mission 3.5/22/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07640130456099), received between Jan 27, 2022 and Jul 22, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 22, 2026Failure to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25904112 ↗
• MalfunctionJun 10, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF AN UNSPECIFIED LESION IN A SEGMENT OF THE PROXIMAL LAD. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE COMPLAINT DEVICE WAS NOT RETURNED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25453264 ↗
• MalfunctionJun 5, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (60 % STENOSIS DEGREE) IN AN UNKNOWN SEGMENT OF A MEDIAL VESSEL. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25405791 ↗
• MalfunctionApr 14, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF AN UNSPECIFIED MEDIAL VESSEL. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24870951 ↗
• MalfunctionFeb 26, 2026Device Dislodged or Dislocated

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (60% STENOSIS DEGREE) IN A MILDLY TORTUOUS SECTION OF THE OSTIAL CX/LEFT MAIN. THE STENT CAME OFF THE BALLOON BEFORE REACHING THE PRE-DILATED TARGET LESION. THE UNDEPLOYED STENT WAS RETRIEVED WITH A SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24452149 ↗
• MalfunctionFeb 13, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS SEGMENT OF THE MEDIAL LAD. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24332223 ↗
• MalfunctionJan 9, 2026Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (89 % STENOSIS DEGREE) IN A SEVERELY TORTUOUS SEGMENT OF THE DISTAL RCA. PRE-DILATION OF THE LESION WAS PER-FORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION. THE PHYSICIAN WAS ABLE TO CROSS THE LESION USING ANOTHER MANUFACTURERS STENT. THE COMPLAINT DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019209 ↗
• MalfunctionNov 17, 2025Failure to Advance; Failure to Advance

  THE ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 % STENOSIS DEGREE) IN A MODERATELY TORTUOUS SEGMENT OF A MEDIAL CORONARY BIFURCATION. IT IS UNKNOWN IF A PRE-DILATION OF THE LESION WAS PERFORMED. THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENT'S BODY BUT COULD NOT CROSS THE LESION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23566641 ↗
• MalfunctionNov 11, 2024Failure to Advance; Failure to Advance

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MODERATELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN A MILDLY TORTUOUS PART OF THE DISTAL RCA. AFTER PRE-DILATION OF THE LESION, THE AFFECTED DEVICE WAS INTRODUCED INTO THE PATIENTS BODY BUT COULD NOT CROSS THE LESION. DURING THE ADVANCEMENT OF THE DEVICE, THE WIRE AND GUIDING CATHETER POSITION WERE LOST. A SMALL WIRE PERFORATION WAS NOTED. NO FURTHER ATTEMPTS TO TREAT THE LESION WERE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20658861 ↗
• MalfunctionApr 22, 2024Fluid/Blood Leak; Device Dislodged or Dislocated; Fluid/Blood Leak; Device Dislodged or Dislocated

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A LESION (STENOSIS DEGREE: 95 PERCENT) IN THE MILDLY TORTUOUS MID SVG TO DIAGONAL. A SHOCKWAVE PRE-DILATATION WAS DONE OVER A FILTER-WIRE PROTECTION DEVICE. THE ORSIRO MISSION WAS INTRODUCED BUT COULD NOT BE INFLATED MORE THAN 2 ATM DUE TO HOLE IN BALLOON. STENT AND BALLOON HAD TO BE REMOVED WITH GUIDE CATHETER AND SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19154468 ↗
• InjuryJun 26, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A MILDLY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS MID RCA. AN ACUTE STENT THROMBOSIS OCCURRED 1.5 H AFTER IMPLANTATION OF THE ORSIRO MISSION STENT. AFTER BALLOONING OF THE STENT THROMBOSIS, A TIMI 3 FLOW WAS RE-ESTABLISHED. PATIENT WAS LOADED ON ASPIRIN AND PLAVIX AFTER INITIAL PROCEDURE. IV CANGRELOR WAS GIVEN DURING REPEAT INTERVENTION TO OPEN THROMBOSED STENT. PATIENT WAS TRANSFERRED TO HEART CATH RECOVERY FOR DURATION OF CANGRELOR DRIP AND THEN TRANSFERRED TO ICU. ONE DAY AFTER PROCEDURE THE PATIENT WAS DOING GREAT AND WAS DISCHARGED HOME.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17206215 ↗
• MalfunctionJan 27, 2022Inflation Problem; Material Puncture/Hole; Inflation Problem; Material Puncture/Hole

  AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE WAS PLACED DOWN IN A VEIN GRAFT AND INFLATED TO NOMINAL PRESSURE, BUT THE BALLOON WOULD NOT INFLATE DUE TO A PIN HOLE AT DISTAL END OF BALLOON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367508 ↗