Orsiro 3.5/13/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07640130438941), received between Apr 26, 2019 and Jun 1, 2021 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2021Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE MILDLY TORTUOUS OSTIAL CX. THE DEVICE COULD NOT PASS THE HEAVILY CALCIFIED LESION EVEN WITH THE USE OF A GUIDELINER (TELEFLEX 6F). DURING ATTEMPT TO REMOVE THE DEVICE, THE STENT DISLODGED. THE STENT COULD NOT BE SNARED AND WAS ADAPTED TO THE VESSEL WALL WITH ANOTHER STENT. IT WAS STATED THAT THE STENT MIGHT GOT CAUGHT IN A PREVIOUS IMPLANTED STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11917291 ↗
• InjuryFeb 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  (B)(6) STUDY: AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. AFTER SUCCESSFUL STENT DEPLOYMENT, THE PATIENT DEVELOPED AN INTRAMURA HEMATOMA PROXIMALLY. THIS REQUIRED AN ADDITIONAL STENT TO BE IMPLANTED PROXIMAL TO FIRST STENT.

  Patient problems: Hematoma

  MAUDE report 11348508 ↗
• MalfunctionOct 9, 2020Device 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 CX. DURING DEVICE PREPARATION NEGATIVE PRESSURE WAS SUPPLIED. UPON DELIVERY, STENT BECAME DISLODGED ON CALCIUM SHELF AND MOVED DOWNSTREAM. STENT WAS SNARED OUT NEAR SFA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10658311 ↗
• MalfunctionFeb 24, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF SEVERELY CALCIFIED LESION (99 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS PROXIMAL LAD. DURING ATTEMPT OF LESION CROSSING, THE STENT WAS DISLODGED IN THE BODY. STENT WAS REMOVED ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9747107 ↗
• MalfunctionSep 10, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO US DRUG ELUTING STENT SYSTEM WAS SELECTED FOR USE. UPON INSPECTION OF THE DELIVERY SYSTEM FOR REINSERTION IT WAS DETECTED THAT THE STENT WAS DISPLACED DISTALLY. THE STENT WAS INITIALLY DELIVERED THROUGH A GUIDELINER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8982333 ↗
• MalfunctionAug 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR TREATMENT. DURING PREPARATION WHILE REMOVING THE PROTECTION CAP THE STENT DISLODGED AND REMAINED IN THE CAP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8941823 ↗
• MalfunctionAug 21, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN FOR THE TREATMENT OF A CALCIFIED AND TORTUOUS LESION IN THE PROXIMAL RCA. AFTER PRE-DILATATION THE TARGET LESION COULD NOT BE CROSSED AND THEREFORE THE ORSIRO WAS REMOVED FROM THE PATIENTS BODY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915888 ↗
• MalfunctionMay 16, 2019Failure to Advance; Failure to Advance

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING LESION CROSSING THE STENT COULD NOT PASS THE LESION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8617829 ↗
• MalfunctionApr 26, 2019Failure to Advance; Failure to Advance

  AN ORSIRO CORONARY DRUG-ELUTING STENT SYSTEM WAS SELECTED TO TREAT A MODERATE CALCIFIED LESION (80% STENOSIS DEGREE) IN A CORONARY BYPASS GRAFT. DESPITE PREDILATATION THE DEVICE COULD NOT CROSS THE LESION. AFTER FURTHER DILATATION THE DEVICE COULD BE DELIVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8558378 ↗