Resolute Onyx™ RONYX22526UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00643169556744), received between Aug 22, 2017 and Aug 16, 2023 — classified as 4 deaths, 13 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 16, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO) IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. ANOTHER SAME SIZE RESOLUTE ONYX STENT WAS USED TO COMPLETE THE PROCEDURE. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD OR EXTEND PATIENT HOSPITALIZATION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17560647 ↗
• MalfunctionApr 26, 2023Use of Device Problem; Use of Device Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT WAS IMPLANTED 4 DAYS PAST ITS EXPIRATION DATE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16814251 ↗
• InjuryMar 16, 2023Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component; Fracture; Activation, Positioning or Separation Problem; Detachment of Device or Device Component

  A PATIENT HAD FOUR RESOLUTE ONYX CORONARY DRUG ELUTING STENTS IMPLANTED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED WHAT WAS THOUGHT TO BE A HEART ATTACK AND ATTENDED THE ED (EMERGENCY DEPARTMENT). IT WAS DISCOVERED THROUGH IMAGING THAT ONE OF THE RESOLUTE ONYX STENT'S HAD FRACTURED. A NON-MEDTRONIC STENT WAS IMPLANTED INSIDE THE FRACTURED STENT. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Angina; Anxiety; Dizziness; Dyspnea; Insufficient Information; Myocardial Infarction; Nausea; Obstruction/Occlusion

  MAUDE report 16553153 ↗
• InjuryOct 4, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A NON TORTUOUS AND NON CALCIFIED LESION, WITH 90% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE PHYSICIAN FELT RESISTANCE WHEN TRYING TO ADVANCE THE STENT THROUGH THE END OF THE CATHETER SO HE PULLED EVERYTHING BACK AS ONE UNIT AND THE STENT DISLODGED DURING THIS PROCESS. IT WAS THEN NOTED THAT THE STENT WAS IN THE RIGHT POSTERIOR TIBIAL AND A SNARE WAS USED TO REMOVE THE DEVICE. THE PATIENT IS ALIVE AND NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12567333 ↗
• MalfunctionApr 8, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION IN THE MID LCX. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PREDILATED MULTIPLE TIMES USING SEVERAL BALLOONS. IT WAS REPORTED THAT THE STENT WAS DISLODGED AS A RESULT OF ENGAGEMENT WITH A NON MEDTRONIC GUIDE EXTENSION CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11632956 ↗
• InjuryMar 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE DISTAL CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT PROBLEMS CROSSING THE LESION IN THE DISTAL LEFT CX OCCURRED AND A DECISION TO SWITCH FROM A RADIAL TO FEMORAL APPROACH WAS MADE. WHEN REMOVING THE SYSTEM FROM THE PATIENT'S RADIAL ARTERY, THE STENT BECAME DISLODGED WHEN IT WAS BEING PULLED THROUGH THE SHEATH. THE STENT WAS MASSAGED OUT OF THE ACCESS SITE BY HAND AND WAS SUCCESSFULLY REMOVED FROM THE ACCESS SITE. A 2.25X22 RESOLUTEONYX WAS SUCCESSFULLY DELIVERED VIA FEMORAL APPROACH. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11403276 ↗
• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE CX. DURING A STAGED PROCEDURE, ONE RESOLUTE ONYX WAS IMPLANTED IN THE R-PDA. APPROXIMATELY 23 MONTHS POST INDEX PROCEDURE AND 22 MONTHS POST STAGED PROCEDURE, PATIENT SUFFERED FROM CHRONIC TOTAL ARTERY OCCLUSION. EVENT WAS TREATED WITH PERCUTANEOUS INTERVENTION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11257362 ↗
• InjuryOct 16, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE LESION WAS 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. THE DEVICE WAS NOT KINKED OR RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE DETACHED AT THE CATHETER DURING DELIVERY THROUGH THE VESSEL. THE DETACHED PORTION OF THE STENT CATHETER WAS REMOVED SAFELY BY TRAPPING IT WITH A CORONARY BALLOON INSIDE A TURNPIKE GUIDE EXTENSION CATHETER AND REMOVING FROM THE PATIENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10688790 ↗
• MalfunctionSep 4, 2020Burst Container or Vessel; Burst Container or Vessel

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON BURST DURING STENT DEPLOYMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10493081 ↗
• MalfunctionAug 28, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE CALCIFIED LESION AND STENT DISLODGEMENT OCCURRED DURING DELIVERY TO / AT A LESION. THE DISLODGED STENT WAS NOT REMOVED AND LEFT IN THE PATIENTS BODY. IT WAS STATED THAT IT IS NOT KNOWN IF THE STENT PASSED A PREVIOUSLY DEPLOYED STENT, HOWEVER, ANOTHER STENT WAS OBSERVED IN THE SAME VESSEL. THE PROCEDURE WAS COMPLETED BY PRE-DILATION AND DEPLOYMENTS OF TWO NON-MEDTRONIC STENTS. 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 10464189 ↗
• DeathAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE R-PDA. APPROXIMATELY 32 MONTHS POST PROCEDURE, PATIENT SUFFERED VENTRICULAR FIBRILLATION, HAD A CARDIAC ARREST AND DIED. DEATH IS CLASSIFIED AS A SUDDEN CARDIAC DEATH. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10452844 ↗
• MalfunctionJul 28, 2020Material Deformation; Material Deformation

  ONE RESOLUTE ONYX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND STENT DEFORMATION OCCURRED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332659 ↗
• DeathApr 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST DIAGONAL AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE LCMA. ANOTHER RESOLUTE ONYX DES WAS ALSO IMPLANTED. APPROXIMATELY 32 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM VENTRICULAR TACHYCARDIA AND DIED. EVENT WAS TREATED WITH MEDICATION, CPR AND ICD FIRED SHOCK. DEATH WAS CLASSIFIED AS SUDDEN CARDIAC DEATH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Death

  MAUDE report 9961671 ↗
• DeathMar 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE FIVE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE 1ST DIAGONAL, TWO IN THE LAD AND TWO IN THE CX. APPROXIMATELY 13 MONTHS LATER THE PATIENT SUFFERED CVA/STROKE TREATED WITH HOSPITALIZATION, TPA AND MECHANICAL THROMBECTOMY AND PEG TUBE PLACEMENT. THE PATIENT IS RECOVERING. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE.

  Patient problems: Stroke/CVA

  MAUDE report 9864455 ↗
• InjuryJan 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT A LESION. IT IS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED LESS THAN 24 HOURS POST STENT IMPLANTATION.

  Patient problems: Thrombus

  MAUDE report 9600377 ↗
• InjuryDec 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THE CX WAS TREATED WITH TWO RESOLUTE ONYX DES. DISSECTION WAS REPORTED IN THE TARGET AREA.

  Patient problems: Intimal Dissection

  MAUDE report 9503588 ↗
• InjurySep 4, 2019Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED OSTIUM PROXIMAL DIAGONAL BRANCH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE STENT. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT COULD NOT CROSS THE LESION. WHEN THE DEVICE WAS PULLED BACK, THE STENT DISLODGED FROM THE DELIVERY SYSTEM IN THE PATIENT'S RADIAL ARTERY JUST ABOVE THE SHEATH. A SNARE WAS USED TO REMOVE THE STENT. PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 8960163 ↗
• MalfunctionAug 23, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT. IT WAS REPORTED THAT THE DEVICE COULD NOT CROSS THE LESION AND ON THE FIRST ATTEMPT TO CROSS STENT DEFORMATION OCCURRED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8924777 ↗
• InjuryJan 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE DAY OF THE INDEX, TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED: ONE IN THE LAD AND ONE IN THE CX. THE NEXT DAY THE PATIENT SUFFERED PCI RELATED MI. THE TARGET VESSEL IS UNKNOWN.

  Patient problems: Myocardial Infarction

  MAUDE report 8239210 ↗
• InjuryJan 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REVASCULARISATION PROCEDURE, IT WAS REPORTED THAT A DISSECTION OCCURRED DURING THE IMPLANTATION OF A RESOLUTE ONYX DRUG ELUTING STENT IN THE R-PDA. THIS EVENT WAS TREATED WITH ANOTHER RESOLUTE ONYX DRUG ELUTING STENT.

  Patient problems: Intimal Dissection

  MAUDE report 8212496 ↗
• MalfunctionNov 5, 2018Material Deformation; Material Deformation

  IT WAS REPORTED THAT ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT FAILED TO CROSS THE LESION AND STENT STRUT DAMAGE WAS OBSERVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037884 ↗
• DeathOct 11, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION IN THE CX ARTERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED IN THE LEFT MAIN ARTERY DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DEVICE WAS NOT REMOVED FROM THE PATIENT AND THE PATIENT WAS SENT TO THE OPERATING ROOM FOR GRAFTING. IT WAS REPORTED THAT THE PATIENT EXPIRED ON THE (B)(6) 2018.

  Patient problems: Death

  MAUDE report 7955423 ↗
• MalfunctionJul 31, 2018Failure to Advance; Material Deformation

  A RESOLUTE ONYX DEVICE WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 85% STENOSIS IN THE OSTIUM OF THE DIAGONAL BRANCH. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED USING A 2.25 X 20 MM NON-MDT BALLOON. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE PRE-DILATATION BALLOON HAD DIFFICULTY CROSSING THE LESION. IT IS REPORTED THAT THE STENT MADE THE TURN IN THE DIAGONAL ABOUT 4MM AND STOPPED; THE STENT COULD NOT BE ADVANCED. WHEN IT WAS REMOVED FROM THE PATIENT, DEFORMATION AT THE TIP WAS OBSERVED. THE PROCEDURE WAS COMPLETED USING A 2.25 X 20 MM NON-MDT POBA DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7734250 ↗
• MalfunctionJul 13, 2018Material Deformation

  IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A LESION IN THE MID LAD WITH MILD TORTUOSITY AND CALCIFICATION AND 100% STENOSIS. NO ABNORMALITIES WERE NOTED IN THE PATIENT¿S ANATOMY. THE DEVICE WAS REMOVED FROM PACKAGING WITH NO ISSUES NOTED. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. RESISTANCE WAS ENCOUNTERED, AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED DURING POSITIONING AND ADVANCEMENT IN THE ARTERY. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, IT WAS NOTED THAT A STENT STRUT WAS LIFTED. THE LESION WAS RE-PREDILATED USING A NON-MEDTRONIC BALLOON AND TWO OTHER RESOLUTE ONYX STENTS WERE IMPLANTED WITH NO ISSUES NOTED. POST PROCEDURE, THE PATIENT COMPLAINED OF PAIN AND AN ECHO WAS PERFORMED. FLUID WAS FOUND IN THE PATIENT'S HEART. PERICARDIOCENTESIS WAS PERFORMED AND 35CC OF FLUID REMOVED. THE PATIENT CODED AND PASSED AWAY ON THE HELICOPTER PAD AWAITING TRANSFER. NO FURTHER PATIENT COMPLICATIONS REPORTED FOR THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient; Pain; Pericardial Effusion

  MAUDE report 7684773 ↗
• InjuryJun 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION WITH 95% STENOSIS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS WIRED AND PRE-DILATED. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED DURING DELIVERY. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE DEVICE FAILED TO CROSS THE CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE STENT THEN DISLODGED DURING REMOVAL. THE STENT WAS CRUSHED AGAINST THE VESSEL WALL WITH A DIFFERENT BALLOON TO THE DELIVERY SYSTEM BALLOON. PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7599948 ↗