Resolute Onyx™ RONYX25030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00643169556843), received between Oct 23, 2017 and Jul 22, 2022 — classified as 4 deaths, 20 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS IMPLANTED TO TREAT A CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE PROXIMAL LEFT MAIN. IT WAS REPORTED THAT FOLLOWING STENT PLACEMENT OPTICAL COHERENCE TOMOGRAPHY (OCT) SHOWED THE STENT WAS NOTED TO BE UNDER DEPLOYED IN THE PROXIMAL REGION. THE STENT WAS DILATED FURTHER USING ONE NC EUPHORA RX (2.75 X 20MM) PTCA BALLOON CATHETER. NO FURTHER COMPLICATIONS WERE REPORTED DURING THE PROCEDURE AND THE PCI WAS SUCCESSFUL. THE PATIENT WAS ON DAPT FOLLOWING THE PROCEDURE. IT WAS REPORTED THAT THREE WEEKS FOLLOWING THE STENT IMPLANT AND ONGOING 6 MONTHS AFTER, THE PATIENT'S HANDS WERE SWOLLEN, HAD RASHES ALL OVER, SKIN DRYNESS, AND A FUNKY SMELL. THE PATIENTS HAIR TURNED CURLY AND STARTED FALLING OUT AND HAS NOT GROWN BACK SINCE, HOWEVER THE RASHES ARE NOW GONE. THE SCALP, GROIN AREA AND EARS WERE WEEPING AND NAILS WERE FALLING OFF. THE PATIENT HAD SIGNED A CONSENT FORM FOR AN EXPERIMENTAL STENT. IT WAS STATED THAT THE PATIENT HAD BEEN TO THE DERMATOLOGIST AND DOCTORS AND THAT THE PATIENT WAS SICK. IT WAS NOTED THAT THERE WAS A CHANGE IN MEDICATION TO PLAVIX. THE PATIENT HAS NOT RECEIVED ANY MEDICAL TREATMENT FOR THE SYMPTOMS THAT

  Patient problems: Insufficient Information

  MAUDE report 15083245 ↗
• MalfunctionDec 6, 2021Material Deformation; Material Deformation

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 95% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. IT WAS STATED THAT THE DAMAGE OCCURRED ON THE PROXIMAL SIDE OF THE STENT. A BUDDY WIRE WAS USED TO KEEP THE DIAGONAL OPEN, PROXIMAL TO THE LESION. THE PROCEDURE WAS COMPLETED USING A 2.5 X 26 MM RESOLUTE ONYX STENT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12932349 ↗
• InjuryJun 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION EXHIBITING 90% STENOSIS LOCATED IN THE MID LEFT MAIN (LM) CORONARY ARTERY. 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 THE STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. THE STENT WAS REMOVED FROM THE PATIENT WITH A SNARE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12056349 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, 4 RESOLUTE ONYX DES WERE IMPLANTED IN THE CX AND LAD. DURING A REVASCULARIZATION PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED FROM A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 12056280 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE, 4 RESOLUTE ONYX DES WERE IMPLANTED IN THE CX AND LAD. DURING A REVASCULARIZATION PROCEDURE, TWO RESOLUTE ONYX DES WERE IMPLANTED APPROXIMATELY 13 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED FROM A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 12056277 ↗
• MalfunctionMay 21, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE, AN ATTEMPT WAS DE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT RESISTANCE WAS NOTED WHEN CROSSING THE LESION AND STENT DEFORMATION OCCURRED. IT WAS STATED THAT THE STENT STRUT WAS STICKING UP. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11861563 ↗
• InjuryMar 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE 1ST DIAGONAL AND ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 16 MONTHS POST PROCEDURE PATIENT SUFFERED A STROKE AND DIED. THE DEATH WAS CLASSIFIED AS NON-CARDIAC DEATH.

  Patient problems: Stroke/CVA

  MAUDE report 11580839 ↗
• InjuryNov 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE FOUR RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED IN THE RCA. APPROXIMATELY 26 MONTHS LATER THE PATIENT SUFFERED NON-TARGET VESSEL MYOCARDIAL INFARCTION. THE PATIENT RECOVERED. THE SITE AND THE SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. CEC ADJUDICATED THE EVENT AS MI (VESSEL UNKNOWN)

  Patient problems: Myocardial Infarction

  MAUDE report 10800847 ↗
• MalfunctionSep 29, 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, MODERATELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE MID OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. 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 BALLOON BURST/RUPTURED DURING STENT DEPLOYMENT. IT WAS STATED THAT THE ISSUE OCCURRED DURING FIRST INFLATION AT 6ATM. 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 10599733 ↗
• DeathMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, FOUR RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. SEVEN MEDTRONIC PTA BALLOONS WERE ALSO USED DURING PROCEDURE. APPROXIMATELY 32 MONTHS POST PROCEDURE, PATIENT SUFFERED UNSTABLE ANGINA WITH KNOWN CORONARY ARTERY DISEASE AND WAS TREATED WITH CHANGE IN MEDICATION. A MONTH LATER, PATIENT EXPIRED. DEATH IS OF UNKNOWN CLASSIFICATION. INVESTIGATOR AND SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTIPLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 10074216 ↗
• 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 9864465 ↗
• InjuryMar 20, 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 8 MONTHS POST PROCEDURE, PATIENT SUFFERED ACUTE CEREBROVASCULAR ACCIDENT (CVA) WITH LEFT SIDED DEFICIT. PATIENT NOT RECOVERED. CEC ADJUDICATED STROKE NO EVENT AND COMMENTED "NO MRI EVIDENCE OF ACUTE STROKE. EXARCERBATION OF CHRONIC CONDITION DUE TO HYPOPERFUSION." INVESTIGATOR AND SPONSOR ASSESSED EVENT AS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 9859018 ↗
• InjuryMar 18, 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 LAD. APPROXIMATELY TWO WEEKS LATER AND DURING A STAGED PROCEDURE, ANGIOGRAPHY AND REVASCULARIZATION WERE PERFORMED, AND A RESOLUTE INTEGRITY DES WAS IMPLANTED IN THE RCA. CEC ADJUDICATED THE EVENT AS NON-TARGET VESSEL MI AND SIDE BRANCH OCCLUSION OF THE RCA (NON-TVR VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 9847301 ↗
• InjuryMar 16, 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, SEVERELY CALCIFIED LESION EXHIBITING 95% 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 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 FAILED DELIVERY. IT WAS REPORTED THAT THE STENT GOT CAUGHT ON A PREVIOUSLY DEPLOYED STENT. IT WAS STATED THAT AN ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT USING A SNARE BUT RETRIEVAL WAS UNSUCCESSFUL AS THE WIRE WAS NO LONGER THROUGH THE STENT. THE DISLODGED STENT WAS PUSHED DOWN FURTHER IN THE ARTERY AND CRUSHED AGAINST THE ARTERY WALL USING ANOTHER RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Injury

  MAUDE report 9834701 ↗
• MalfunctionMar 12, 2020Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; 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 MILDLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING CTO (CHRONIC TOTAL OCCLUSION-100%) LOCATED IN THE PROXIMAL POSTERIOR DESCENDING ARTERY (PDA). 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING / ADVANCEMENT. IT WAS STATED THAT TWO ATTEMPTS WERE MADE TO DELIVERY THE STENT. IT WAS STATED THAT ON THE FIRST ATTEMPT TO DELIVER THE STENT, THERE WAS NO ISSUE WITH DELIVERY OR REMOVAL FROM THE VASCULATURE. THE STENT WAS ADVANCED TO THE LESION LOCATION OF PDA AND REMOVED FROM THE GUIDE IN ORDER TO PLACE A NON MEDTRONIC BALLOON IN THE PROXIMAL POSTEROLATERAL BRANCH (PLB) TO PREVENT JAILING AND PLAQUE SHIFT OF THE PLB. THE STENT WAS INSPECTED PRIOR TO THE SECOND ATTEMPT TO DELIVER THE STENT TO ENSURE THE STENT WAS STILL INTACT. THE STENT WOULD NOT ADVANCE TO THE LESION LOCATION IN THE PDA ON THIS ATTEMPT. THE STENT DETACHED DURING ADV

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9822554 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE LAD. APPROX 1 DAY POST INDEX PROCEDURE THE PATIENT SUFFERED ELEVATED CARDIAC ENZYMES. CEC ADJUDICATED THE EVENT AS NON-Q-WAVE MI (TARGET VESSEL), 3RD UDMI PERI-PCI. CEC COMMENTED THAT SIDE BRANCH OCCLUSION WAS ALSO SEEN. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9693146 ↗
• InjuryDec 19, 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 USED TO TREAT THE LAD. IT IS REPORTED THAT DURING THE PROCEDURE THERE WAS A QUESTIONABLE PERFORATION OF THE DIAGONAL ARTERY TREATED WITH BALLOON TAMPONADE.

  Patient problems: Perforation

  MAUDE report 9494217 ↗
• MalfunctionNov 12, 2019Material Deformation; Material Deformation

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 80% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. THE ONYX STENT WAS BEING REMOVED SO AN ADDITIONAL PRE-DILATION COULD BE PERFORMED. IT WAS REPORTED THAT UPON REMOVAL OF THE STENT, THE STENT GOT CAUGHT ON THE GUIDING CATHETER AND THE STENT STRUTS WERE RAISED. THE PROCEDURE WAS COMPLETED USING TWO 2.5 X 15MM ONYX STENTS. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9309850 ↗
• InjuryOct 30, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY EVIDENCE OF ISCHEMIA AND STABLE ANGINA. DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX RX CORONARY DES WERE IMPLANTED IN THE LAD. POST PROCEDURE ANGIO REVEALED 100% STENOSIS IN THE 1ST DIAGONAL. IT IS UNKNOWN IF ANY INTERVENTION WAS CARRIED OUT TO TREAT THE STENOSIS.

  Patient problems: Occlusion

  MAUDE report 9257681 ↗
• InjurySep 27, 2019Adverse 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 IN THE RCA. APPROXIMATELY 21 DAYS POST INDEX PROCEDURE, PATIENT SUFFERED FROM ACUTE CVA. THE INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Stroke/CVA

  MAUDE report 9127539 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX STENT WAS IMPLANTED INTO THE R-PDA. APPROXIMATELY 4 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED GASTROENTERITIS. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND POSSIBLY TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 8934661 ↗
• InjuryJul 31, 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 - ONE INTO THE 1ST DIAGONAL AND ONE INTO THE LAD. DURING A STAGED PROCEDURE FOUR RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE RCA. APPROX 5 MONTHS POST STAGED PROCEDURE THE PATIENT SUFFERED NSTEMI OF THE RCA AND TOTAL OCCLUSION OF THE RCA. THE PATIENT RECEIVED A LEFT HEART CATH AND WAS TREATED WITH MEDICATION. THE INVESTIGATOR AND SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 8844908 ↗
• InjuryJun 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX WAS IMPLANTED INTO THE LAD, ONE INTO THE CX AND TWO INTO THE 1ST DIAGONAL. ONE DAY POST INDEX PROCEDURE, ELEVATED CARDIAC ENZYMES WAS REPORTED. NO ACTION WAS TAKEN. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR ANTI-PLATELET MEDICATION. THE OUTCOME OF THE EVENT IS UNKNOWN. CEC ADJUDICATED THE EVENT AS NON Q WAVE MI (TV) 3RD UDMI PERI-PCI AND COMMENTED THERE WAS A SIDE BRANCH OCCLUSION.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 8673968 ↗
• InjuryMay 27, 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 AND CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE PROXIMAL RAMUS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED THROUGH THE GUIDE USING A SNARE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury

  MAUDE report 8644130 ↗
• InjuryMay 23, 2019Detachment of Device or Device Component

  THE STENT SHEARED OFF THE BALLOON AFTER INSERTION AND WAS SUCCESSFULLY SNARED AND REMOVED AFTER THE STENT SHEARED OFF OF THE BALLOON. NO HARM TO THE PATIENT, STENT WAS SUCCESSFULLY REMOVED. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, RESOLUTE ONYX¿ (PER SITE REPORTER). ON THE PHONE WITH THEM NOW, ON HOLD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8635541 ↗