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Orsiro 2.75/15/140Recalls & reported problems

Biotronik AG · Class 3 · Implant

Adverse event reports
6
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07640130438989), received between May 3, 2019 and Mar 29, 2022 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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

Device problems

  • Failure to Advance3
  • Device Dislodged or Dislocated1
  • Material Deformation1
  • Use of Device Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions3
  • No Consequences Or Impact To Patient1
  • No Known Impact Or Consequence To Patient1
  • Vascular Dissection1

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 29, 2022Material Deformation; Material Deformation

    AN ORSIRO MISSION DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A CALCIFIED LESION (90 PERCENT STENOSIS DEGREE). DURING LESION CROSSING STENT STRUTS WERE DEFORMED. ANOTHER STENT WAS USED TO COMPLETE THE INTERVENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13943173 ↗
  • MalfunctionFeb 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. DURING A DIFFICULT CASE THE STENT DISLODGED FROM BALLOON AND WAS FOUND IN THE LEFT MAIN. THE STENT WAS RETRIEVED WITH A SNARE. A 6F GUIDELINER WAS USED DURING PROCEDURE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 11373598 ↗
  • MalfunctionOct 28, 2020Failure to Advance; Failure to Advance

    AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. THE DEVICE COULD NOT BE ADVANCED. ANOTHER ORSIRO WAS IMPLANTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10750673 ↗
  • InjuryAug 11, 2020Use of Device Problem; Use of Device Problem

    AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. PATIENT UNDERWENT A HEART CATHETERIZATION DUE TO AN NSTEMI. THE STENT WAS PLACED TO OM1, CULPRIT LESION. A SMALL DISSECTION WAS NOTED AFTER IMPLANTATION. ANOTHER OSIRO STENT WAS PLACED TO DISSECTED AREA DISTAL TO INITIAL STENT, HOWEVER OVERLAPPING. PATIENT WAS STABLE THROUGHOUT THE PROCEDURE AND OVERNIGHT AND WAS DISCHARGED HOME.

    Patient problems: Vascular Dissection

    MAUDE report 10393632 ↗
  • MalfunctionJul 9, 2019Failure to Advance

    THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. AFTER PRE-DILATATION THE ORSIRO STENT COULD NOT PASS THE SEVERELY CALCIFIED LESION IN THE LAD.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8774233 ↗
  • MalfunctionMay 3, 2019Failure to Advance; Failure to Advance

    AN ORSIRO DRUG-ELUTING STENT WAS CHOSEN TO TREAT A LESION (70% STENOSIS DEGREE) IN A DISTAL RCA. THE DEVICE GOT STUCK IN A TORTUOUS SEGMENT OF THE MID RCA AND COULD NOT BE ADVANCED TO THE TARGET LESION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8580067 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.