Resolute Onyx™ RONYX22534UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00643169556768), received between Oct 3, 2017 and Apr 13, 2026 — classified as 11 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Material Deformation

  IT WAS REPORTED THAT TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE FOUND TO BE DAMAGED AND DID NOT WORK DURING A CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24855781 ↗
• MalfunctionApr 13, 2026Material Deformation

  IT WAS REPORTED THAT TWO RESOLUTE ONYX CORONARY DRUG ELUTING STENTS WERE FOUND TO BE DAMAGED AND DID NOT WORK DURING A CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24855715 ↗
• MalfunctionJul 27, 2022Material Deformation; 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 WITH 95% STENOSIS IN THE LEFT CIRCUMFLEX ARTERY (LCX). NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO DIFFICULTIES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE INSPECTED BEFORE USE AS USUAL. 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 NOTED WHILE ADVANCING THE DEVICE TO THE LESION. IT WAS REPORTED THAT THE WIRE WAS FRAYED AT THE PROXIMAL END. ON WITHDRAWAL, THE STENT CAUGHT ON THE GUIDE TIP, SOMEWHERE IN THE BODY OF THE STENT, AND THE STENT DEFORMED. THE EVENT OCCURRED IN VIVO. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15111072 ↗
• InjuryNov 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX TO TREAT A SEVERELY CALCIFIED AND SEVERELY TORTUOUS LESION IN THE PROXIMAL CIRCUMFLEX ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. DURING ADVANCEMENT WHEN THE STENT PASSED THE PROX LCX, COMPLICATIONS AROSE BY STENT ENTRAPMENT AND DISLODGEMENT OCCURRED AT THE LM BIFURCATION INTO THE PROX LCX. MULTIPLE RETRIEVAL TECHNIQUES INCLUDING MANUAL INTERVENTION WERE USED BUT THE PHYSICIAN WAS UNABLE TO RETRIEVE THE STENT. THE STENT WAS REMOVED IN SURGERY. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12759239 ↗
• MalfunctionJul 6, 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 MODERATELY CALCIFIED AND MODERATELY TORTUOUS LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED. THE LESION WAS NOT PRE DILATED. THE DEVICE DID 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 DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS REMOVED WITH THE GUIDELINER. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12119972 ↗
• InjuryMay 24, 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 MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID CX ARTERY WITH 95% STENOSIS. IT WAS NOTED THAT THE VESSEL WAS AN ANOMALOUS CIRCUMFLEX WHICH AROSE FROM THE AORTA. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PREDILATED. 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 LESION. THE STENT REMAINED IN THE PATIENT AND WAS UNABLE TO BE RETRIEVED. IT WAS INFORMED THAT THE STENT DISLODGEMENT OCCURRED DUE TO THE STRUTS BECOMING ENTANGLED WITH THE STRUTS OF A PREVIOUSLY DEPLOYED STENT. ONCE ENTANGLED, THE REMOVAL OF THE DELIVERY SYSTEM RESULTED IN THE STENT REMAINING AT THE OSTIAL PORTION OF THE ANOMALOUS CIRCUMFLEX. THE DISLODGED STENT WAS DILATED AGAINST THE OSTIAL/PROXIMAL WALL OF THE ARTERY WITH A CORONARY BALLOON. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11869263 ↗
• 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 11580833 ↗
• MalfunctionJun 15, 2020Material Deformation; 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 LOCATED IN THE DISTAL 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. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10152175 ↗
• InjuryNov 12, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A NON CALCIFIED, MODERATELY TORTUOUS LESION EXHIBITING 85% STENOSIS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WERE NO DIFFICULTIES REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED USING A 2.0 X 12 MM NON-MEDTRONIC DEVICE AT 14-16 ATM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT HOWEVER IT WAS NOTED THAT THE PATIENT HAD A STENT PREVIOUSLY IMPLANTED IN THE PROXIMAL RAMUS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. IT WAS REPORTED THAT RESISTANCE WAS FELT AND THEREFORE AN ATTEMPT WAS MADE TO WITHDRAW THE STENT DELIVERY SYSTEM AND A STENT DISLODGEMENT OCCURRED IN THE LEFT MAIN. ATTEMPTS MADE TO USE A SMALL BALLOON TO RETRIEVE THE DISLODGED STENT WERE UNSUCCESSFUL. SEVERAL ATTEMPTS WERE MADE TO CAPTURE THE STENT WITH A SNARE BUT FAILED. GROIN ACCESS WAS THEN OBTAINED AT THE LCA AND IT WAS

  Patient problems: Injury

  MAUDE report 9308983 ↗
• InjurySep 23, 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 LAD. APPROXIMATELY 5 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED CARDIAC CHEST PAIN AND WAS TREATED WITH MEDICATION AND STENTING OF THE LAD. THE CEC ADJUDICATED A MYOCARDIAL INFARCTION (TARGET VESSEL). THE CEC ALSO ADJUDICATED THE REVASCULARIZATION AS CLINICALLY DRIVEN (TARGET LESION REVASCULARIZATION). THE INVESTIGATOR AND SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION BUT POSSIBLY RELATED TO THE DEVICE. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9104572 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMPTED BY UNSTABLE ANGINA. DURING THE INDEX PROCEDURE, TWO RESOLUTE ONYX STENTS WERE IMPLANTED INTO THE LAD. APPROX 25 DAYS POST INDEX PROCEDURE, THE PATIENT SUFFERED GI BLEED. THE PATIENT WAS ON DAPT AT THE TIME OF THE EVENT. THE PATIENT WAS TREATED WITH BLOOD TRANSFUSION. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE BUT POSSIBLY RELATED TO ANTI-PLATELET MEDICATION. THE PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 8347524 ↗
• MalfunctionJan 17, 2019Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A HIGHLY CALCIFIED <(>&<)> HIGHLY TORTUOUS LESION IN THE MID RCA. THERE WAS NO RESISTANCE NOTED WHILE REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND THE HYPOTUBE KINKED WHILE ATTEMPTING TO CROSS THE LESION. IT WAS SUBSEQUENTLY REPORTED THAT ANOTHER RESOLUTE ONYX HAD A LIFTED STRUT WHEN PULLED BACK INTO THE GUIDE CATHETER AT AN ACUTE ANGLE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8256707 ↗
• MalfunctionJan 7, 2019Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS AND A EUPHORA PTCA BALLOON CATHETER TO TREAT IN STENT RESTENOSIS IN A MILDLY TORTUOUS AND CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE DISTAL LAD. BOTH STENTS WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED FOR BOTH STENTS. THE LESION WAS PRE-DILATED. BOTH DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. IT WAS REPORTED THAT THE FIRST STENT WAS UNABLE TO CROSS THE LESION, UPON REMOVAL STENT DEFORMATION WAS OBSERVED. IT IS INDICATED THAT THE STENT WAS PARTIALLY UNRAVELED BUT STILL ATTACHED TO THE DELIVERY SYSTEM. A SECOND STENT WAS ATTEMPTED OF THE SAME SIZE TO TREAT THE LESION HOWEVER ALSO FAILED TO CROSS THE LESION AND UPON REMOVAL STENT DEFORMATION WAS OBSERVED AGAIN WITH A STRUT OF THE STENT BECOMING LIFTED. AN ATTEMPT WAS NEXT MADE TO DILATE THE LESION USING A 2.0X30MM EUPHORA BALLOON, DURING INFLATION THE BALLOON RUPTURED. NO FURTHER TREATMENT WAS COMPLETED. IT IS INDICATED THAT THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO ADVERSE OUTCOMES OCCURRED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8221271 ↗
• MalfunctionJan 7, 2019Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS AND A EUPHORA PTCA BALLOON CATHETER TO TREAT IN STENT RESTENOSIS IN A MILDLY TORTUOUS AND CALCIFIED LESION EXHIBITING 80% STENOSIS LOCATED IN THE DISTAL LAD. BOTH STENTS WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED FOR BOTH STENTS. THE LESION WAS PRE-DILATED. BOTH DEVICES PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING BOTH DEVICES. IT WAS REPORTED THAT THE FIRST STENT WAS UNABLE TO CROSS THE LESION, UPON REMOVAL STENT DEFORMATION WAS OBSERVED. IT IS INDICATED THAT THE STENT WAS PARTIALLY UNRAVELED BUT STILL ATTACHED TO THE DELIVERY SYSTEM. A SECOND STENT WAS ATTEMPTED OF THE SAME SIZE TO TREAT THE LESION HOWEVER ALSO FAILED TO CROSS THE LESION AND UPON REMOVAL STENT DEFORMATION WAS OBSERVED AGAIN WITH A STRUT OF THE STENT BECOMING LIFTED. AN ATTEMPT WAS NEXT MADE TO DILATE THE LESION USING A 2.0X30MM EUPHORA BALLOON, DURING INFLATION THE BALLOON RUPTURED. NO FURTHER TREATMENT WAS COMPLETED. IT IS INDICATED THAT THE PATIENT WAS HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND NO ADVERSE OUTCOMES OCCURRED. THE PATIENT IS REPORTED TO BE ALIVE WITH NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8221265 ↗
• MalfunctionJul 17, 2018Detachment of Device or Device Component; Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT IS REPORTED THAT AN UNDEPLOYED RESOLUTE ONYX DES STENT CAME OFF THE BALLOON IN THE VESSEL. 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 7693275 ↗
• InjuryMar 28, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS AND CALCIFIED LESION LOCATED IN THE MID OBTUSE MARGINAL ARTERY, EXHIBITING 95% STENOSIS. MULTIPLE CALCIFIED AREAS WITH TORTUOSITY WAS REPORTED IN RELATION TO ANATOMY. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. THE STENT WAS INSPECTED POST REMOVAL OF THE PROTECTIVE SHEATH, 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 DELIVERY TO/AT LESION. IT WAS DESCRIBED THAT THE STENT DISLODGED FROM BALLOON. PHYSICIAN WENT THROUGH PROXIMAL PART OF STENT AND DEPLOYED THEN WIRE THROUGH A STRUT AND THE DISTAL PART OF THE STENT WAS CRUSHED TOWARDS VESSEL INTIMA. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7377211 ↗
• InjuryMar 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE MID CIRCUMFLEX ARTERY. NO ISSUES NOTED REMOVING THE DEVICE FROM THE HOOP/TRAY. THE PATIENT HAD NO PREVIOUS STENTS. THE ARTERY WAS BALLOONED SEVERAL TIMES. THE ONYX DEVICE COULD NOT CROSS THE LESION DESPITE SEVERAL ATTEMPTS. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE STENT DISLODGED IN THE PROXIMAL PART OF ARTERY AND PARTIALLY IN GUIDE. THE STENT WAS SNARED INTO THE GUIDE AND THEN PULLED EVERYTHING OUT SAFELY. NO PATIENT INJURY IS REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7356698 ↗
• InjuryDec 15, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 80% STENOSIS IN THE MID RCA. ABNORMALITIES ARE REPORTED IN RELATION TO THE ANATOMY WHEREBY THE DEGREE OF CALCIFICATION WAS NOT FULLY APPRECIATED PRIOR TO STENTING. THERE WAS NO DAMAGE NOTED TO PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. 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 AND EXCESSIVE FORCE WAS NOT USED. THE INFLATION DEVICE REMAINED ON NEUTRAL. IT WAS REPORTED THAT A SECTION OF THE RCA WAS CALCIFIED PRIOR TO A PREVIOUS STENT AND THE NEW LESION. DESPITE PRE-DILATING THE AREA WITH A 2.0X8 MM NON-MDT BALLOON, THE ONYX DEVICE FAILED TO CROSS THE CALCIFICATION AND DISLODGED. NO ATTEMPT WAS MADE TO REMOVE THE DISLODGED STENT. THE DISLODGED STENT WAS DEPLOYED PROXIMAL TO THE LESION WHERE IT DISLODGED. A SERIES OF 9 BALLOONS, FIVE OF THEM BEING MEDTRONIC BALLOONS OF INCREASING SIZE WERE USED TO INCREASE THE DIAMETER OF THE STENT TO APPROXIMATEL

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 7120453 ↗
• InjuryOct 4, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING USE OF A RESOLUTE ONYX DRUG ELUTING STENT THAT THE STENT DISLODGED. THE TARGET LESION LOCATED IN THE MID RCA HAD MODERATE CALCIFICATION, MILD TORTUOSITY WITH EXHIBITED 80% STENOSIS. THERE WERE NO ISSUES REPORTED ON REMOVING THE DEVICE FROM THE HOOP OR REMOVING THE PROTECTIVE SHEATH. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED WITH NEGATIVE PREP PERFORMED WITH NO ISSUES REPORTED. THE LESION WAS PRE-DILATED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE HOWEVER NO EXCESSIVE FORCE WAS EXERTED. IT WAS REPORTED THAT THE STENT DISLODGED WHEN PULLING BACK/WITHDRAWING THE DEVICE. THE DISLODGED STENT WAS REMOVED USING A SNARE. NO PATIENT INJURY REPORTED.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6914065 ↗
• InjuryOct 3, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED AND TORTUOUS LESION IN THE MID LAD. THERE WAS A PREVIOUSLY DEPLOYED STENT AT THE LESION. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. THE INFLATION DEVICE REMAINED ON NEUTRAL PRESSURE DURING DELIVERY OF THE DEVICE. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS CRUSHED AGAINST THE VESSEL WALL AND ANOTHER UNKNOWN BRAND STENT WAS PLACED OVER IT. THE PHYSICIAN REPORTED THAT HE WAS TOO AGGRESSIVE WHICH IS WHY THE STENT CAME OFF. THE PATIENT IS ALIVE WITH NO INJURIES.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6910876 ↗