Integrity INT30012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994798480), received between Mar 9, 2017 and Feb 28, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 28, 2018Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN INTEGRITY BARE METAL STENT WAS INTENDED TO BE USED TO TREAT A LESION IN THE OSTIAL, PROXIMAL RCA WHICH WAS MILDLY TORTUOUS AND MILDLY CALCIFIED. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO THE ANATOMY. NO DAMAGE WAS NOTED TO THE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AS IT WAS UNABLE TO PASS THROUGH ANOTHER BMS. WHEN THE PHYSICIAN ATTEMPTED TO PULL BACK THE DEVICE, RESISTANCE WAS MET. THE PHYSICIAN THEN PULLED THE DELIVERY SYSTEM BACK AND WAS ABLE TO REMOVE THE DEVICE FROM THE PATIENT. UPON INSPECTION POST-REMOVAL, THE STENT STRUTS APPEARED TO BE BENT BACKWARDS AND THE STENT APPEARED TO BE SLIGHTLY DISPLACED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7302974 ↗
• MalfunctionFeb 13, 2018Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE AN INTEGRITY STENT IN THE MID RCA. THE LESION WAS HEAVILY CALCIFIED, AND MILDLY TORTUOUS. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. THE LESION WAS PREDILATED. NO ISSUES WERE NOTED WHEN THE DEVICE WAS INSPECTED BEFORE USE. RESISTANCE NOTED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THIS WAS CAUSED BY THE CALCIUM. AGGRESSIVE FORCE WAS USED. IT WAS REPORTED THAT STENT DEFORMATION IN-VIVO OCCURRED DURING POSITIONING/ADVANCEMENT. A STENT STRUT FLARED ON THE PROXIMAL EDGE. NO STENT WAS DEPLOYED AS NONE WOULD CROSS. THE PATIENT DID NOT SUFFER ANY INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7265893 ↗
• InjuryMar 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, TWO INTEGRITY STENTS WERE IMPLANTED IN THE RCA AND ONE RESOLUTE ONYX RX DRUG ELUTING STENT IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED NSTEMI. THE PATIENT WAS TREATED WITH MEDICATION AND THE EVENT REMAINS UNRESOLVED, CONTINUING WITH TREATMENT.

  Patient problems: Myocardial Infarction

  MAUDE report 6390800 ↗