Resolute Integrity™ RSINT40038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169037267), received between Jun 7, 2019 and Jul 3, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE A RESOLUTE INTEGRITY RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING(LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT IS REPORTED THAT AN EXPIRED STENT WAS IMPLANTED IN THE PATIENT. THE PRODUCT EXPIRED ON THE 25TH OF MAY 2019. THE PATIENT IS ALIVE WITH NO INJURY. NO INTERVENTION AS A RESULT OF EXPIRED PRODUCT. HOWEVER IT WAS REPORTED THAT THE PATIENT ALSO RECEIVED A RSINT40038UX ALSO IN THE MID LAD. THE PATIENT WAS NOTED TO HAVE A PERFORATION OF THE ARTERY AFTER SECOND STENT DEPLOYMENT. TWO NON-MEDTRONIC COVERED STENTS WERE PLACED IN THE MID LAD DURING THIS CASE. PT REMAINED IN THE HOSPITAL OVER THE WEEKEND AND RETURNED TO CATH LAB FOR REPEAT ANGIOGRAPHY. PATIENT WAS NOTED TO HAVE INADEQUATE SEALING OF PERFORATION. A 4.0 NON-MEDTRONIC STENT WAS PLACED, PATIENT LEFT LAB IN STABLE CONDITION. MD THAT PERFORMED INTERVENTION STATES PATIENT ¿DOING WELL¿.

  Patient problems: Perforation

  MAUDE report 8757265 ↗
• MalfunctionJun 7, 2019Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE A RESOLUTE INTEGRITY RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING(LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT IS REPORTED THAT AN EXPIRED STENT WAS IMPLANTED IN THE PATIENT. THE PRODUCT EXPIRED ON THE 25TH OF MAY 2019. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8677790 ↗