Orsiro Mission 4/9/140Recalls & reported problems
Biotronik AG · Class 3 · Implant
All models of Orsiro Mission (49)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07640130455863), received between Feb 26, 2024 and Feb 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated1
Patient problems
- Chest Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE TREATED LESION WAS A 100 PERCENT OCCLUDED LARGE OM. A WIRE AND MICROCATHETER WERE USED TO CROSS THE LESION. PRE-DILATATION WAS DONE AND A 3.0/40 ORSIRO WAS PLACED AND POST DILATED. SIGNIFICANT CALCIFICATION WAS NOTED ON IVUS PROXIMAL TO THE STENT AND A ORSIRO MISSION 4.0/9 WAS SELECTED TO PLACE PROXIMAL TO THE PREVIOUS IMPLANTED STENT. WHILE POSITIONING, THE ORSIRO MISSION 4.0/9 STENT CAME OFF THE DELIVERY BALLOON AND MIGRATED DISTALLY TO THE DISTAL VESSEL BUT WAS STILL ON THE WIRE. A BALLOON WAS PLACED INSIDE THE DISLODGED STENT AND INFLATED TO ADHERE THE STENT TO THE WALL OF THE DISTAL OM. A GUIDE EXTENSION WAS THEN USED AND A ORSIRO 4.0/13 WAS PLACED PROXIMAL INSIDE THE ORSIRO 3.0/40. THE PATIENT HAD CONTINUOUS CHEST PAIN THROUGHOUT THE PROCEDURE. A SECOND CATH WAS DONE ON (B)(6) 2024.
Patient problems: Chest Pain
MAUDE report 18778803 ↗
Other Coronary drug-eluting stent devices
- SYNERGY™ H7493926038300Boston Scientific Corporation · Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Boston Scientific Corporation · Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Boston Scientific Corporation · Coronary drug-eluting stent9 deaths90 reports
- XIENCE Sierra™ 1550350-33Abbott Vascular Inc. · Coronary drug-eluting stent1 recall32 reports
- SYNERGY™ H7493926016250Boston Scientific Corporation · Coronary drug-eluting stent6 deaths82 reports
- Resolute Onyx™ RONYX30022UXMedtronic, Inc. · Coronary drug-eluting stent6 deaths76 reports
- SYNERGY™ H7493926024300Boston Scientific Corporation · Coronary drug-eluting stent3 deaths75 reports
- Resolute Onyx™ RONYX30015UXMedtronic, Inc. · Coronary drug-eluting stent3 deaths73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page