Resolute Onyx™ RONYX35012UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 00643169557062), received between Jul 18, 2017 and Nov 8, 2022 — classified as 2 deaths, 28 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (19 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 40 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 2022Fracture; Fracture

  TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WERE IMPLANTED. THE PATIENT REPORTED EXPERIENCING DISCOMFORT AND IT WAS NOTICED THAT ONE OF THE IMPLANTED STENTS WAS FRACTURED. THE FRACTURED STENT WAS REPAIRED WITH A NON-MEDTRONIC STENT. IT IS NOT KNOWN WHICH ONE OF THE TWO RESOLUTE ONYX STENTS FRACTURED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Discomfort; Insufficient Information

  MAUDE report 15750809 ↗
• MalfunctionNov 4, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS NOT REMOVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15723907 ↗
• InjurySep 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT BOTH STENTS FAILED TO CROSS THE LESION AND DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. IT WAS LATER REPORTED THAT A TOTAL OF THREE STENTS WERE USED IN THE PROCEDURE. ONE OF THE STENTS WAS REMOVED FROM THE PATIENT AS A NO-CROSS. THERE WERE TWO STENTS LEFT IN THE PATIENT. ONE STENT WAS FLOATING WHILE THE OTHER STENT CROSSED OK. IT IS UNKNOWN WHICH DEVICE WAS LEFT FLOATING. IT WAS DESCRIBED AS A TOUGH CASE WHICH OCCURRED VERY LATE ON THE WEEKEND. THE PATIENT WAS MOVED TO A LARGER HOSPITAL FOR FURTHER CARE IMMEDIATELY AFTER THIS PROCEDURE. IT IS UNKNOWN WHAT HAPPENED TO THE PATIENT AFTER THEIR TRANSFER. NO FURTHER INJURY REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15438616 ↗
• InjuryApr 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 THE STENT DISLODGEMENT OCCURRED DURING DELIVERY AT THE LESION. THE STENT CAME OFF THE BALLOON. THE DISLODGED STENT WAS NOT REMOVED. THE STENT WAS CRUSHED AGAINST THE VESSEL IN THE DISTAL RIGHT CORONARY ARTERY WITH A SMALL EUPHORA BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 14186258 ↗
• MalfunctionMar 26, 2022Device 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, MODERATELY CALCIFIED LESION LOCATED IN THE MID CIRCUMFLEX ARTERY (CX). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. 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. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT WAS FOUND INSIDE THE NON MEDTRONIC GUIDE EXTENSION CATHETER WHEN THE CATHETER WAS REMOVED FROM THE BODY. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13916607 ↗
• InjuryJun 28, 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 MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION IN THE MID RCA WITH 100% CTO. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. 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 DELIVERY TO/AT LESION. THE STENT DISLODGED FROM THE SHAFT. THE STENT WAS NOT REMOVED FROM THE PATIENT AND WAS DEPLOYED IN THE DISTAL LESION. THE PATIENT IS ALIVE WITH NO INJURY REPORTED AND REMAINED STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12075275 ↗
• MalfunctionJun 8, 2021Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 70-80% STENOSIS IN THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED 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 AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED DURING STENT DEPLOYMENT AFTER THE FIRST INFLATION. IT WAS ALSO REPORTED THAT A BALLOON BURST/LEAK OCCURRED. THE STENT WAS DEPLOYED USING OTHER BALLOONS TO POST-DILATE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957365 ↗
• MalfunctionJun 3, 2021Burst 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 LESION. IT WAS REPORTED THAT A GUIDE WIRE WAS ADVANCED INTO THE VESSEL AND ACROSS THE LESION. A 3.0 X8MM NON MEDTRONIC BALLOON WAS USED TO PREDILATE THE BALLOON. THE DEVICE WAS THEN ADVANCED. DURING DEPLOYMENT THE STENT BALLOON RUPTURED AT APPROX. 2-3 ATM. THE PROXIMAL AND DISTAL STENT EDGES WERE FLARED BUT THE STENT WAS NOT FULLY DEPLOYED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930945 ↗
• InjuryMay 4, 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 TORTUOUS, SEVERELY CALCIFIED LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT A LESION. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11768183 ↗
• InjuryFeb 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE THREE RESOLUTE ONYX DES. IT WAS STATED THAT AFTER DEPLOYING THE THREE STENTS THE DISTAL PART OF THE VESSEL LOOKED WORSE AND IT WAS DECIDED TO DEPLOY A FOURTH RESOLUTE ONYX. THE STENT WAS UNABLE TO GET THROUGH SO IT WAS REMOVED, THE PROXIMAL LESION WAS PREDILATED AND THE STENT WAS THEN DEPLOYED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11320717 ↗
• DeathJan 22, 2021Adverse 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 CIRCUMFLEX. APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM CARDIOMYOPATHY. PATIENT WAS SENT TO THE HOSPICE. THE PATIENT DIED. DEATH WAS CLASSIFIED AS NON-SUDDEN CARDIAC DEATH. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Cardiomyopathy

  MAUDE report 11213829 ↗
• InjuryDec 21, 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 SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX ARTERY (CX). 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. 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 THE TARGET LESION WAS IN THE CIRCUMFLEX ARTERY, AND THERE WERE MULTIPLE STENTS IN THE CIRCUMFLEX ARTERY AND THE LEFT MAIN ARTERY. IT WAS STATED THAT THE STENT GOT STUCK ON REMOVAL BACK INTO LEFT MAIN AND DISLODGED THERE. THE DISLODGED STENT WAS NOT REMOVED AND WAS DEPLOYED IN THE LEFT MAIN WITH MULTIPLE BALLOONS USED, THE FINAL BALLOON USED WAS AN 4.0 NC BALLOON. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11045275 ↗
• InjuryNov 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WERE IMPLANTED; ONE IN THE L-PDA AND ONE IN THE CIRCUMFLEX. TWO RESOLUTE ONYX DES WERE IMPLANTED DURING A REVASC PROCEDURE, ONE IN THE CX AND ONE IN THE OM. APPROXIMATELY 31 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED CHEST DISCOMFORT WITH EXERTION. PATIENT WAS HOSPITALIZED AND PTCA WITH BRACHYTHERAPY OF THE CX CARRIED OUT. A NON-MEDTRONIC BALLOON WAS USED. PATIENT RECOVERED. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. STENT THROMBOSIS IN THE CIRCUMFLEX (CASS #19) WAS CONFIRMED BY ANGIO. EVENT WAS TREATED WITH POBA. CEC ADJUDICATED THE EVENT AS TLR PERCUTANEOUS INTERVENTION OF THE CX.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 10873980 ↗
• InjuryAug 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE FOUR RESOLUTE ONYX RX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A BILATERAL PULMONARY EMBOLISM. THE PATIENT WAS TREATED WITH MEDICATION AND HOSPITALIZATION. THE PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICES OR ANTIPLATELET MEDICATION.

  Patient problems: Embolism; Embolism/Embolus; Myocardial Infarction

  MAUDE report 10447199 ↗
• DeathApr 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN GRAFT 2ND OM AND GRAFT 3RD OM. APPROXIMATELY 16, PATIENT SUFFERED SUSTAINED VENTRICULAR TACHYCARDIA AND DIED SAME DAY. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10013071 ↗
• InjuryFeb 19, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT WAS USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL 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 AND EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. A 2.0MM BALLOON WAS USED TO EXPAND THE DISLODGED STENT AT THE LESION. IT WAS STATED THAT ROTOBLATING WAS PERFORMED BUT THE PHYSICIAN COULD NOT GET TO THE LESION SITE. A NON-MEDTRONIC GUIDE EXTENSION CATHETER WAS ALSO USED IN THE DELIVERY ATTEMPT. IT WAS STATED THAT THE LESION WAS VERY CALCIFIED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 9726942 ↗
• InjuryFeb 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED - ONE INTO THE L-PDA AND ONE INTO THE CX. DURING A REVASCULARIZATION PROCEDURE ((B)(6) 2019) TWO RESOLUTE ONYX WERE IMPLANTED IN THE CX AND OM3. APPROXIMATELY 29 MONTHS POST INDEX PROCEDURE AND 6 MONTHS POST REVASCULARIZATION PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION . EVENT WAS TREATED WITH POBA IN THE CX. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9660046 ↗
• InjuryOct 18, 2019Adverse 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 RCA. APPROXIMATELY 12 MONTHS POST PROCEDURE, PATIENT SUFFERED IN-STENT RESTENOSIS WHICH IS REPORTED TO BE RELATED TO STENT THROMBOSIS. STENT THROMBOSIS IN THE TARGET VESSEL RCA CONFIRMED BY ANGIO. REVASCULARIZATION OF THE RCA WITH THE IMPLANTATION OF STENT WAS CARRIED OUT. EVENT UNRESOLVED. INVESTIGATOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE AND ANTI PLATELET MEDICATION.

  Patient problems: Injury; Myocardial Infarction; Thrombus

  MAUDE report 9206900 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, TWO RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. TWO DAYS LATER A STAGED PROCEDURE WAS CARRIED OUT TO TREAT THE LAD WITH THE IMPLANTATION OF THREE RESOLUTE ONYX DRUG-ELUTING STENTS. POST STAGED PROCEDURE, A PLAQUE SHIFT OCCURRED IN 2ND DIAGONAL WITH TIMI FLOW 1-2 CAUSING ST ELEVATION IN LATERAL LEADS ON TELEMETRY. INVESTIGATOR ASSESSED EVENT IS PROBABLY RELATED TO DEVICE AND NOT RELATED TO ANTI-PLATELET MEDICATION. CEC ADJUDICATED EVENT AS A NON-Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI-PCI.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9104026 ↗
• InjurySep 16, 2019Adverse 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 LAD, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION OF THE TARGET VESSEL (LAD AND CX). INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9069655 ↗
• InjurySep 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 50% STENOSIS LOCATED IN THE PROXIMAL 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 AND EXCESSIVE FORCE WAS USED DURING DELIVERY. A NON MEDTRONIC GUIDE WIRE WAS USED TO CROSS THE LESION AND A BUDDY WIRE WAS ALSO USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. SIGNIFICANT RESISTANCE WAS NOTED BY PHYSICIAN. THE DISLODGED STENT WAS CRUSHED INTO PLACE USING ANOTHER RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 9021103 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DES WERE USED TO TREAT THE LAD AND CX. DURING A STAGED PROCEDURE THREE DAYS LATER, ONE RESOLUTE ONYX DES WAS USED TO TREAT THE RCA. APPROXIMATELY 2 MONTHS POST PROCEDURES THE PATIENT SUFFERED A STROKE AND WAS TREATED WITH MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR THE ANTI-PLATELET MEDICATION AND THE PATIENT IS RECOVERING.

  Patient problems: Embolism; Stroke/CVA

  MAUDE report 8770550 ↗
• InjuryJul 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE OSTIUM IN THE RIGHT CORONARY ARTERY (RCA). IT WAS REPORTED THAT DURING INSERTION TO THE RIGHT OSTIA LESION THE STENT DISLODGED OFF THE BALLOON. ANOTHER BALLOON WAS USED TO INFLATE THE STENT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8763667 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE CX, ONE RESOLUTE ONYX WAS IMPLANTED IN THE LAD, ONE RESOLUTE ONYX WAS IMPLANTED INTO THE LEFT MAIN AND FOUR EUPHORIA BALLOONS WERE USED TO TREAT THE CX. IT WAS REPORTED THAT ON THE SAME DAY POST PROCEDURE THE PATIENTS TROPONIN LEVELS WERE ELEVATED. CEC ASSESSED THE EVENT AS A NON Q WAVE MI (TARGET VESSEL), MDT EXTENDED HISTORICAL PERI-PCI. THE MI OCCURRED IN THE LCX, LAD AND LEFT MAIN.

  Patient problems: Myocardial Infarction

  MAUDE report 8423780 ↗
• MalfunctionDec 14, 2018Premature Activation; Device Dislodged or Dislocated; Premature Activation; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED IN THE GUIDE CATHETER, THE ENTIRE DELIVERY SYSTEM INCLUDING THE GUIDE WIRE AND GUIDE CATHETER WAS REMOVED. HOWEVER WHILE REMOVING, THE STENT SNAGGED ON THE SHEATH AND DISLODGED OFF THE WIRE 2-3CM BELOW THE RIGHT FEMORAL HEAD IN A SMALL BRANCH WHICH COMES OFF THE PROFUNDA FEMORIS WITH NORMAL FLOW THROUGH AND BEYOND THE STENT. THE STENT WAS OBSERVED TO BE STABLE. THE DISLODGED STENT WAS NOT REMOVED AND REMAINS IN THE PATIENT. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8163690 ↗