Resolute Onyx™ RONYX22515WRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169602236), received between Dec 11, 2017 and Dec 13, 2017 — classified as 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. 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.

• InjuryDec 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PHYSICIAN USED FOUR RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND CALCIFIED LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, EXHIBITING 100% STENOSIS. ARTERY DIAMETER 2.5 MM AND ARTERY LENGTH 24 MM. THE 2.5 X 18 STENT WAS DEPLOYED AT 18ATM FOR 8 SECONDS AND POST DILATED 3 TIMES IN THE DISTAL OF THE PROXIMAL LAD. THE 2.25 X 26 WAS DEPLOYED AT 18 ATM FOR 8 SECONDS AND POST DILATED 4 TIMES. THE 2.25 X 26 STENT WAS DEPLOYED AT 18 ATM FOR 10 SECONDS AND POST DILATED 5 TIMES, 20 ATM FOR 8 SECONDS AND 6 TIMES 20 ATM FOR 6 SECONDS .THE 2.25 X 26 STENTS WERE CONFORMED TO BE DISTAL TO THE 2.5 X 18 HOWEVER, AS THE PATIENT HAD CHEST PAIN HE WAS MOVING AROUND, THE STENTS WERE SEEN TO BE PROXIMAL TO THE FIRST. DURING ANGIOGRAPHY, POST PROCEDURE, THE STENT HAD MOVED PROXIMALLY IN THE LAD. THE 2.25 X 15 WAS DEPLOYED AT 12ATM FOR 8 SECONDS AND POST DILATED 7 AT18 ATM FOR 6 SECONDS. THERE WERE NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING, AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS NO

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 7112113 ↗
• InjuryDec 11, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO RESOLUTE ONYX DRUG ELUTING STENT DEVICES (RONYX25015W AND RONYX22515W) WERE USED TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 90% STENOSIS IN THE MID LAD. THERE WAS NO DAMAGE NOTED TO DEVICE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THERE WERE NO ABNORMALITIES IN RELATION TO ANATOMY. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED. THE 2.5X15 MM RESOLUTE ONYX WAS DEPLOYED IN THE MID LAD AT 20 ATM. THEN THE 2.25X15 MM WAS PLACED DISTAL TO THAT AS THERE WAS STILL A SIGNIFICANT LESION, AFTER OVERLAPPING THE FIRST STENT TO 18ATM. THEN THE BALLOON OF THE RESOLUTE ONYX 2.25X15 WAS USED IN THE MIDDLE OF THE OVERLAP AREA AS A POST DILATION TO 20ATM. AT THIS POINT THERE WERE EXCELLENT RESULTS WITH NO RESIDUAL STENOSIS IN THE MID LAD; NO COMPLICATIONS WERE REPORTED DURING THE PROCEDURE AND THE PATIENT WAS STABLE AT THAT POINT. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED WITHIN 24 HRS OF THE PROCEDURE BEING PERFORMED. THE THROMBUS WAS

  Patient problems: Intimal Dissection; Patient Problem/Medical Problem; Thrombus

  MAUDE report 7103706 ↗