Resolute Onyx™ RONYX30012WRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169602496), received between Jul 5, 2017 and Jan 14, 2022 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD FIVE RESOLUTE ONYX CORONARY DRUG ELUTING STENTS IMPLANTED. IT WAS ALSO REPORTED THAT, APPROXIMATELY 14 MONTHS AFTER THE PROCEDURE, ONE STENT BECAME OCCLUDED AND WAS REPLACED BY A NON MEDTRONIC STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 13256997 ↗
• MalfunctionAug 4, 2021Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE PROMPTED BY STEMI AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT AN 100% OCCLUDED LESION IN THE OBTUSE MARGINAL (OM) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED PRIOR TO USE. IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED IN THE PATIENT APPROX. 2 WEEKS POST EXPIRY DATE. IT WAS STATED THAT TIMI WAS 3 BEFORE STENT IMPLANTATION AND TIMI 0 AFTER STENT DEPLOYMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12272755 ↗
• MalfunctionOct 15, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A LESION. IT WAS REPORTED THAT BOTH BALLOONS THAT THE STENTS WERE MOUNTED ON, LEAKED DURING STENT DEPLOYMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10682427 ↗
• MalfunctionOct 15, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A LESION. IT WAS REPORTED THAT BOTH BALLOONS THE STENTS WERE MOUNTED ON, LEAKED DURING STENT DEPLOYMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10682423 ↗
• MalfunctionSep 1, 2020Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO. IT WAS STATED THAT THE STENT LOOKED STRANGE ON THE X-RAY AS SOON AS IT WENT INTO THE PATIENTS BODY AND IT WAS IMMEDIATELY REMOVED. UPON INSPECTION, THE STENT STRUTS WERE SLIGHTLY LIFTED OFF THE BALLOON. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10475627 ↗
• InjurySep 25, 2019Material Deformation; Material Deformation

  A 3.0 X 12 MM RESOLUTE ONYX OTW STENT WAS RETURNED FOR EVALUATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9115082 ↗
• InjuryJul 5, 2017Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE PATIENT WAS PRESENTED WITH STEMI. IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE A RESOLUTE ONYX OTW DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS PROXIMAL LAD LESION EXHIBITING 95% STENOSIS. NO DAMAGE TO DEVICE PACKAGING AND NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE STENT WAS INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING DELIVERY AND EXCESSIVE FORCE USED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING THE DELIVERY OF THE DEVICE AND THE BALLOON WAS NOT INFLATED TO DEPLOY THE STENT. IT WAS REPORTED THAT THE STENT CAME OFF THE BALLOON WHILE TRYING TO DELIVER TO LESION. THE BALLOON WAS USED TO TRY AND CATCH STENT AND BRING IT BACK TO SHEATH AND WAS RETRIEVED TO A CERTAIN POINT BUT WAS NOT ABLE TO BE REMOVED FROM THE BODY. THE STENT EVENTUALLY BECAME LODGED IN PROFUNDITY AND EMBOLIZED THERE. RESOLUTE ONYX BALLOON CATHETER SHAFT ALSO BROKE DURING THIS PROCESS. THE DETACHMENT OCCURRED MID-CATHETER. THE DETACHED PORTION OF THE DEVICE WA

  Patient problems: Embolism; Patient Problem/Medical Problem

  MAUDE report 6685604 ↗