Integrity INT40012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613994798626), received between Feb 23, 2017 and Oct 10, 2018 — classified as 1 death, 2 injuries.

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. APPROXIMATELY 26 MONTHS POST PROCEDURE, A REVASCULARIZATION WAS CARRIED OUT DURING WHICH TWO INTEGRITY BARE METAL STENTS WERE IMPLANTED IN THE LCX. THE FOLLOWING DAY,THE PATIENT SUFFERED TROPONIN ELEVATION. CEC ADJUDICATED EVENT AS A NON-Q-WAVE MI OF NON-TARGET VESSEL. CEC ALSO ADJUDICATED STENT THROMBOSIS AS NON-EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 7951714 ↗
• InjurySep 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, A RESOLUTE INTEGRITY DRUG ELUTING STENT WAS IMPLANTED IN THE RCA. APPROX. 35 MONTHS POST INDEX PROCEDURE, TWO INTEGRITY BARE METAL STENTS WERE IMPLANTED IN THE CX. ONE DAY POST IMPLANT OF THE INTEGRITY BARE METAL STENTS, TROPONIN ELEVATION WAS REPORTED. CEC ADJUDICATED THE EVENT AS NON-Q WAVE MI OF THE NON-TARGET VESSEL.

  Patient problems: Myocardial Infarction

  MAUDE report 7888479 ↗
• DeathFeb 23, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN IMPLANTED A 4.0 X 12 MM INTEGRITY BARE METAL STENT TO TREAT A MODERATELY CALCIFIED AND MILDLY TORTUOUS OSTIUM OF THE LEFT MAIN CORONARY ARTERY AND CX. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE A CUTTING BALLOON WAS USED AND AN NC EUPHORA BALLOON WAS USED TO PRE-DILATE THE PROXIMAL CIRC AND ALSO TO SUPPORT ADVANCEMENT OF A NON MDT GUIDE EXTENSION CATHETER. THE GUIDE EXTENSION CATHETER WAS ADVANCED DISTAL TO THE LESION AND THE BALLOON WAS REMOVED. THE 4.0 X 12 MM INTEGRITY STENT WAS SUCCESSFULLY DELIVERED TO THE MID CIRC. A 4.0 X 18 MM INTEGRITY STENT WAS INSERTED AND POSITIONED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED UPON ADVANCEMENT OF THE DEVICE BUT NO EXCESSIVE FORCE WAS USED. THE GUIDE EXTENSION CATHETER WAS PULLED BACK WHICH EXPOSED THE STENT AND THEN STENT DEPLOYMENT BEGAN. UPON INFLATING THE BALLOON DELIVERY SYSTEM TO APPROXIMATELY 7 ATM, RESISTANCE WAS LOST AND BLOOD TRAVELED BACK TO INFLATION DEVICE AND THE TECH REPORTED A BURST BALLOON. INITIALLY THE OPERATOR ATTEMPTED TO PULL BACK THE ENTIRE SYSTEM BUT IT WAS ¿STUCK¿ . A FEW SECONDS LATER AS THEY PULLED BACK AGAIN THE DELIVERY SYSTE

  Patient problems: Death

  MAUDE report 6352605 ↗