Orsiro 2.5/18/140Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07640130439030), received between Apr 11, 2019 and Jun 10, 2021 — classified as 2 injuries, 10 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 16, 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.

• MalfunctionJun 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (80 PERCENT STENOSIS DEGREE) IN A MODERATELY TORTUOUS MID RCA. AFTER PRE-DILATATION OF A PREVIOUSLY IMPLANTED STENT, IT WAS NOT POSSIBLE TO ADVANCE THE STENT TO THE MID RCA. THUS, IT WAS REMOVED AND UPON REMOVAL IT WAS NOTICED THAT THE STENT HAS BEEN DISLODGED FROM THE BALLOON AND STAYED INSIDE THE PATIENTS BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11978087 ↗
• MalfunctionMay 11, 2021Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT OF A SEVERELY CALCIFIED LESION (90 PERCENT STENOSIS DEGREE) IN THE SEVERELY TORTUOUS MID CX. STENT WOULD NOT CROSS LESION AND AFTER REMOVAL IT WAS NOTICED THAT THE STENT WAS DAMAGED. MULTIPLE STENTS WERE ATTEMPT TO BE INSERTED BUT NOTHING WAS ABLE TO CROSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806259 ↗
• MalfunctionDec 1, 2020Material Deformation; Material Deformation

  AFTER PRE-DILATATION THE ORSIRO COULD NOT CROSS THE SEVERELY CALCIFIED LESION IN THE MID CX AND A STENT DEFORMATION OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928391 ↗
• InjuryNov 10, 2020Use of Device Problem; Use of Device Problem

  AN ORSIRO US DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR TREATMENT. A DISSECTION HAS OCCURRED AT THE EDGE OF THE STENT IN THE PROXIMAL LAD. THE DISSECTION WAS COVERED BY PLACING A SECOND STENT.

  Patient problems: Vascular Dissection

  MAUDE report 10818100 ↗
• MalfunctionJan 16, 2020Material Puncture/Hole; Device Dislodged or Dislocated; Material Puncture/Hole; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION IN A DISTAL SEVERELY TORTUOUS LAD. AFTER PREPARING THE LESION WITH A ROTABLADE AND PRE-DILATATION THE DEVICE WAS PLACED IN THE LESION. DURING INFLATION THE BALLOON POPPED AT 8 ATM AND THE STENT MIGRATED INTO PATIENTS BODY. THE STENT COULD BE RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9597203 ↗
• MalfunctionDec 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING PROCEDURE THE STENT DISLODGED FROM THE BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9489746 ↗
• MalfunctionDec 2, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A PRE-DILATED SEVERELY CALCIFIED LESION. AFTER A FIRST ORSIRO WAS IMPLANTED, A 6F GUIDELINER WAS LACED. THE ORSIRO 2.5/18 WAS INTRODUCED BUT COULD NOT PASS THE PREVIOUS IMPLANTED STENT. UPON REMOVAL THE STENT DISLODGED PRIOR PULLING BACK THROUGH GUIDELINER AND WAS ADAPTED TO THE VESSEL WALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9397748 ↗
• InjuryOct 30, 2019Patient Device Interaction Problem; Patient Device Interaction Problem

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION WITH 85 PERCENT STENOSIS DEGREE. 4 HOURS AFTER IMPLANTATION PATIENT EXPERIENCED CHEST PAIN. A STENT THROMBOSIS WAS DETECTED.

  Patient problems: Thrombosis

  MAUDE report 9255568 ↗
• MalfunctionJul 24, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION. DESPITE PRE-DILATATION IT WAS NOT POSSIBLE TO CROSS THE LESION WITH THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8824070 ↗
• MalfunctionJul 24, 2019Failure to Advance; Failure to Advance

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A SEVERELY CALCIFIED LESION (95 PERCENT STENOSIS DEGREE). DESPITE PRE-DILATATION IT WAS NOT POSSIBLE TO CROSS THE LESION WITH THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8823178 ↗
• MalfunctionJun 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS CHOSEN TO TREAT A CALCIFIED LESION (90% STENOSIS DEGREE) IN A TORTUOUS CX. AFTER DIRECT STENTING THE ORSIRO COULD NOT PASS THE LESION AND THE STENT DISLODGED FROM THE BALLOON DURING WITHDRAWAL. THEREFORE THE UNDEPLOYED STENT WAS COVERED AND TACKED INTO PLACE WITH ANOTHER STENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8737393 ↗
• MalfunctionApr 11, 2019Material Deformation; Material Deformation

  AN ORSIRO DRUG-ELUTING STENT SYSTEM WAS SELECTED FOR USE. DURING THE ATTEMPT TO CROSS THE CALCIFIED LESION RESISTANCE WAS FELT. THEREFORE THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND A STENT DEFORMATION WAS NOTICED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8506552 ↗