Resolute Onyx™ RONYX27526UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00643169556928), received between Mar 21, 2018 and Jan 31, 2023 — classified as 3 deaths, 18 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2023Use of Device Problem; Use of Device Problem

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION 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 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 IMPLANTED WAS EXPIRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271520 ↗
• InjuryMar 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE DISTAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. 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 STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE PHYSICIAN BELIEVES THAT THE STENT GOT CAUGHT ON THE GUIDEWIRE DURING REMOVAL. A SNARE WAS USED TO REMOVE THE DISLODGED STENT WITH NO ISSUES. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 13755481 ↗
• DeathOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE RCA. APPROXIMATELY 31 MONTHS POST PROCEDURE PATIENT DIED DUE TO MULTI-ORGAN FAILURE, INCLUDING CARDIOPULMONARY AND RENAL FAILURE. THE PATIENT WAS ON DIALYSIS AT TIME OF DEATH. THE CLASSIFICATION OF DEATH IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 12680344 ↗
• InjuryAug 25, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID CIRCUMFLEX (CX) - OBTUSE MARGINAL (OM) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND WHEN THE STENT CATHETER WAS REMOVED IT WAS NOTED THAT THE STENT HAD DISLODGED. THE STENT WAS OBSERVED TO BE IN THE LEFT MAIN (LM). AN ATTEMPT WAS MADE TO REMOVE THE STENT USING A SNARE BUT WAS UNSUCCESSFUL. THE LM WAS THEN STENTED WITH ANOTHER STENT IN ORDER TO CRUSH THE DISLODGED STENT IN THE LM. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12365264 ↗
• MalfunctionApr 7, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MILDLY CALCIFIED AND MODERATELY TORTUOUS LESION IN THE PROXIMAL RCA. BOTH DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PREDILATED. BOTH DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENOSED STENT. BOTH DEVICES EXPERIENCED RESISTANCE DURING ADVANCEMENT AND EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT BOTH DEVICES FAILED TO CROSS THE LESION AND STENT DEFORMATION IN VIVO DURING POSITIONING OCCURRED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626218 ↗
• DeathFeb 18, 2021Adverse 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 CIRCUMFLEX. APPROXIMATELY 18 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM A ISCHEMIC STROKE. IT AS STATED THAT THE PATIENT WAS ALSO HYPOTENSIVE EN-ROUTE TO THE HOSPITAL. PATIENT DIED 4 DAYS LATER THE EVENT. DEATH WAS CLASSIFIED AS NON-CARDIAC DEATH.

  Patient problems: Stroke/CVA

  MAUDE report 11341810 ↗
• InjuryFeb 1, 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 RAMUS. APPROXIMATELY 17 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 11257199 ↗
• InjuryJan 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES WAS IMPLANTED IN THE CX AND THREE RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. ONE INITIAL STENT WAS IMPLANTED IN THE RCA THEN DURING THE PROCEDURE A DISSECTION OF THE RCA OCCURRED, WHICH WAS TREATED WITH A SECOND STENT IN THE RCA. A THIRD STENT WAS IMPLANTED IN RCA POST DISSECTION TREATMENT, DUE TO INSUFFICIENT LESION COVERAGE. THE PATIENT RECOVERED. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT RELATED TO THE ANTI PLATELET MEDICATION. THE INVESTIGATOR ASSESSED THE EVENT WAS PROBABLY RELATED TO THE DEVICE AND NOT RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Vascular Dissection

  MAUDE report 11115712 ↗
• InjuryNov 27, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE MID LEFT MAIN (LM) CORONARY ARTERY AND CIRCUMFLEX (CX) 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 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 A LESION. IT WAS ALSO REPORTED THAT REMOVAL DIFFICULTIES OCCURRED AND DIFFICULTY REMOVING HE DEVICE PRIOR TO STENT DEPLOYMENT OCCURRED. IT WAS STATED THAT THERE WAS A PRIOR STENT IN PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) THAT THE STENT WAS HANGING INTO THE LEFT MAIN COVERING PART OF THE CIRCUMFLEX ARTERY. THE RESOLUTE ONYX STENT GOT CAUGHT ON THE PREVIOUSLY DEPLOYED STENT AND WAS PULLED OFF THE BALLOON. THE STENT WAS REMOVED FROM THE PATIENT USING A SNARE. IT WAS STATED THAT THE PATIENT HAD TO BE AIRLIFTED TO ANOTHER FACILITY FOR THE STENT TO BE REMOVED. THE STENT WAS SUCCESS

  Patient problems: Unspecified Tissue Injury

  MAUDE report 10913265 ↗
• InjurySep 28, 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 RCA. APPROXIMATELY 34 MONTHS LATER THE PATIENT SUFFERED A STROKE. EVENT TREATED WITH HOSPITALIZATION AND ANTIBIOTICS, FLUIDS. PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE ANTI-PLATELET MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 10592237 ↗
• InjuryAug 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING PROCEDURE, ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS IMPLANTED TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING CTO (CHRONIC TOTAL OCCLUSION-100%) 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 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 ACUTE STENT THROMBOSIS OCCURRED. IT WAS STATED THAT VESSEL OCCLUSION OCCURRED DUE TO STENT THROMBOSIS AND TRIFUCATING LAD JUST DISTAL TO THE STENT COMPLETELY SHUT DOWN AND TWO BRANCHES REMAINED OPEN. IT WAS STATED THAT A SUSPECTED UNDETECTED DISTAL EDGE DISSECTION ALSO OCCURRED BUT THIS COULD NOT BE CONFIRMED. THE PATIENT WAS DISCHARGED AND REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Injury; Occlusion; Thrombosis; Vascular Dissection

  MAUDE report 10394736 ↗
• MalfunctionMay 28, 2020Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THERE WAS ISSUES NOTED TO THE PACKAGING. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. IT WAS REPORTED THAT DIFFICULTY REMOVING THE SHEATH AND STYLETTE OCCURRED. IT WAS STATED THAT A BUBBLE WAS NOTICED IN THE PROTECTIVE SHEATH. THE SHEATH AND STYLETTE WAS REMOVED AND THE DEVICE WAS CAREFULLY INSPECTED WITH NO ISSUES NOTED. THE STENT WAS USED AND NO FURTHER ISSUES WERE EXPERIENCED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10095551 ↗
• InjuryMar 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED, ONE IN THE CX AND ONE IN THE LAD. APPROXIMATELY 7 MONTHS LATER THE PATIENT SUFFERED MI OF THE LAD AND CX TREATED WITH HOSPITALIZATION AND NITROGLYCERIN. THE PATIENT RECOVERED. THE INV ESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Myocardial Infarction

  MAUDE report 9852303 ↗
• InjuryMar 16, 2020Adverse 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: ONE IN THE CX AND ONE IN THE LAD. APPROXIMATELY SEVEN MONTHS POST PROCEDURE, PATIENT SUFFERED CORONARY ARTERY DISEASE. PATIENT HAD SEVERE THREE VESSEL (RCA,LCX AND LAD) CAD/AORTIC STENOSIS AND CABG WAS CARRIED OUT TO TREAT THE STENOSIS. IN STENT STENOSIS WAS REPORTED IN THE CX AND LAD. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET MEDICATION. CEC ASSESSED EVENT IS A NON-Q WAVE MI OF TARGET VESSEL, 3RD UDMI SPONTANEOUS. CEC ALSO ADJUDICATED THE REVASCULARISATION AS TL CABG CLINICALLY DRIVEN REVASCULARIZATION OF THE CX AND LAD AND NON-TARGET VESSEL SURGERY, CLINICALLY DRIVEN REVASCULARISATION OF THE RCA.

  Patient problems: Myocardial Infarction

  MAUDE report 9834282 ↗
• InjuryOct 30, 2019Adverse 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 LAD. APPROXIMATELY 7 MONTHS LATER THE PATIENT SUFFERED A GI BLEED. THE EVENT WAS TREATED WITH MEDICATION. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE SITE ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE OR THE ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE ANTI-PLATELET MEDICATION AND NOT RELATED TO STUDY DEVICE.

  Patient problems: Blood Loss

  MAUDE report 9254501 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDEX PROCEDURE WAS PROMPTED BY POSITIVE STRESS TEST. DURING INDEX PROCEDURE, A RESOLUTE ONYX DRUG-ELUTING STENT WAS IMPLANTED IN THE LAD. APPROXIMATELY 14 MONTHS POST PROCEDURE, PATIENT SUFFERED MYOCARDIAL INFARCTION OF THE TARGET VESSEL AND WAS TREATED WITH REVASCULARIZATION. SPONSOR ASSESSED EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET MEDICATION.

  Patient problems: Injury; Myocardial Infarction; Thrombus

  MAUDE report 9144340 ↗
• InjuryAug 23, 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. APPROXIMATELY 2 MONTHS POST PROCEDURE PATIENT SUFFERED CHEST PAIN. NO ACTION WAS TAKEN. THE CEC ADJUDICATED A NON-Q-WAVE MI 3RD UDMI SPONTANEOUS OF UNKNOWN VESSEL OCCURRED. 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 ANTI-PLATELET MEDICATION AND POSSIBLY TO THE DEVICE. THE PATIENT IS RECOVERING.

  Patient problems: Myocardial Infarction

  MAUDE report 8925318 ↗
• MalfunctionJul 31, 2019Inflation Problem; Activation, Positioning or Separation Problem; Inflation Problem; Activation, Positioning or Separation Problem

  TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE INTENDED TO BE USED IN AN INDEX PROCEDURE TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. IT WAS INDICATED THAT TWO STENTS WERE ATTEMPTED TO BE USED. IT WAS REPORTED THAT THE RESOLUTE ONYX (27.5 X 26 MM) STENT WAS UNABLE TO BE DEPLOYED AND WAS REMOVED INTACT. THE RESOLUTE ONYX (2.75 X 34 MM) STENT WAS DEPLOYED AT 9ATM FOR 15 SECONDS. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX STENT OF A BIGGER SIZE (RONY X 5.0 X 15U X). THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8844843 ↗
• InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY STABLE ANGINA. DURING THE INDEX PROCEDURE THREE RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE RCA. 7 DAYS POST INDEX PROCEDURE THE PATIENT SUFFERED GI BLEEDING. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION. SAFETY ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND POSSIBLY RELATED TO ANTI-PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 8645693 ↗
• InjuryMay 24, 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 LAD. APPROX ONE MONTH POST INDEX PROCEDURE THE PATIENT SUFFERED A STROKE. THE PATIENT IS RECOVERING. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE AND UNLIKELY TO BE RELATED TO ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT UNLIKELY TO BE RELATED TO THE INDEX DEVICE AND UNLIKELY TO BE RELATED TO ANTI-PLATELET MEDICATION.

  Patient problems: Stroke/CVA

  MAUDE report 8639550 ↗
• DeathApr 17, 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 USED TO TREAT THE LAD. 2 DAYS POST PROCEDURE PATIENT DIED. NO ACTION WAS TAKEN. INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR INDEX DEVICE.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 8523191 ↗
• InjuryNov 21, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT POST IMPLANTATION OF A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT, THE STENT COLLAPSED. THE PATIENT HAD ANOTHER PROCEDURE TO REPAIR THIS WHERE THEY IMPLANTED A NON-MEDTRONIC STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8094380 ↗
• InjuryAug 10, 2018Adverse 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 INTO THE LAD. APPROXIMATELY 1 YEAR POST INDEX PROCEDURE, THE PATIENT SUFFERED NON-STEMI (MI) IN THE LAD. THIS WAS TREATED WITH TARGET VESSEL REVASCULARIZATION OF THE LAD. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR ANTI-PLATELET MEDICATION. SPONSOR ASSESSED THE REVASCULARIZATION AS A TVR.

  Patient problems: Myocardial Infarction; Patient Problem/Medical Problem

  MAUDE report 7772238 ↗
• InjuryMay 22, 2018Migration or Expulsion of Device; Material Deformation; Migration or Expulsion of Device; Material Deformation

  PREVIOUSLY TWO RESOLUTE ONYX RX DRUG ELUTING STENTS WERE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). IT WAS REPORTED THAT THE LESION WAS EXTREMELY CALCIFIED. HAZINESS WAS OBSERVED POST IMPLANTATION. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICES FROM THE HOOP. THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT THE PATIENT PRESENTED LESS THAN TWO WEEKS POST STENT PLACEMENT WITH POSSIBLE THROMBUS OR OBSTRUCTION BETWEEN THE TWO IMPLANTED RESOLUTE ONYX STENTS. IT WAS INDICATED THAT THE STENTS WERE OVERLAPPING AT IMPLANT. AT FOLLOW UP, TISSUE PROLAPSE WAS OBSERVED BETWEEN THE TWO STENTS. A CONCERN WAS EXPRESSED THAT THE STENT MAY HAVE FRACTURED AT THE POINT OF OVERLAP. THERE WAS A QUESTION AS TO THE PATIENTS COMPLIANCE TO DAPT. IT IS BELIEVED THE PATIENT MAY HAVE STOPPED TAKING IT AND THAT THE TISSUE PROLAPSE OBSERVED MAY HAVE BEEN THROMBUS. A NON-M

  Patient problems: Occlusion; Patient Problem/Medical Problem; Thrombus

  MAUDE report 7532532 ↗
• InjuryMar 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A HEAVILY CALCIFIED LESION IN THE RCA. TORTUOSITY WAS MODERATE. PROXIMAL AND DISTAL PREVIOUS STENTS WERE PRESENT. THE DISTAL STENT HAD IN-STENT RESTENOSIS (ISR). NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. AN ATTEMPT WAS MADE TO DIRECTLY STENT THE LESION WITH THE RESOLUTE ONYX. THE DEVICE WAS PASSED THROUGH THE PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE DEVICE COULD NOT CROSS THE DISTAL IN-STENT LESION. THE ATTEMPT WAS A LITTLE FORCEFUL, BUT EXCESSIVE FORCE WAS NOT USED. THE STENT CATHETER WAS REMOVED AND IT WAS NOTED THAT THE STENT HAD DISLODGED AND WAS IN THE VESSEL. THE STENT COULD NOT BE SNARED. ANOTHER STENT WAS USED TO INTENTIONALLY TRAP THE RESOLUTE ONYX STENT AGAINST THE PREVIOUS STENT. THE PATIENT WAS UNHARMED. PATIENT STATUS IS ALIVE WITH NO INJURY.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7356717 ↗