Resolute Onyx™ RONYX22538UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00643169556775), received between Dec 15, 2017 and Dec 15, 2025 — classified as 1 death, 8 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (13 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated; Inadequacy of Device Shape and/or Size; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CORONARY INTERVENTION INVOLVING ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. AS THE RESOLUTE ONYX DEVICE WAS BEING PULLED BACK INTO THE TELESCOPE, THE STENT CAME OFF THE BALLOON AT THAT POINT. THE TARGET LESION WAS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY WHICH EXHIBITED MODERATE TORTUOSITY AND MODERATE CALCIFICATION WITH 100% LESION STENOSIS. A DISSECTION WAS NOTED DISTAL TO THE LESION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE DISLODGED STENT WAS NOT REMOVED AND REMAINS IN THE PATIENT. A 1.25MM SPRINTER BALLOON WAS USED AS AN INTERVENTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Atrial Fibrillation; Dyspnea; Ischemia; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23801559 ↗
• MalfunctionMay 23, 2022Difficult to Remove; Device Dislodged or Dislocated; Material Deformation; Difficult to Remove; Device Dislodged or Dislocated; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE OSTIUM OF THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT NEGATIVE PREP WAS PERFORMED WITH ISSUES NOTED. THE NEGATIVE PREP WAS THEN PERFORMED DURING THE PROCEDURE. 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. WHEN THE STENT DEFORMATION WAS IDENTIFIED AN ATTEMPT WAS MADE TO REMOVE THE WHOLE SYSTEM HOWEVER IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING THE REMOVAL FOLLOWING FAILED DELIVERY. THE DISLODGED STENT WAS LOST IN THE PATIENTS ARM PIT. THE STENT WAS LEFT IN THE PATIENTS ULNAR ARTERY, AND THE PATIENT APPEARED TO BE DOING FINE. THE PROCEDURE WAS COMPLETED BY IMPLANTING A RESOLUTE ONYX 2.0 X 26MM DEVICE IN THE RIGHT CORONARY ARTERY (RCA). THE PATIENT IS REPORTED AS BEING ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469367 ↗
• MalfunctionAug 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE LEFT CORONARY ARTERY (LCA). IT WAS REPORTED THAT AFTER BALLOON INFLATION, THE STENT DISLODGED FROM THE BALLOON AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12317702 ↗
• MalfunctionApr 16, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED USING A SC PTA BALLOON. 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 AN ATTEMPT TO CROSS THE LESION FAILED AND STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11676849 ↗
• InjuryAug 24, 2020Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation; Device Damaged by Another Device; Device Dislodged or Dislocated; Material Deformation

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A MILD CALCIFIED, MODERATE TORTUOSITY LESION EXHIBITING 100% CHRONIC TOTAL OCCLUSION IN THE MID RIGHT CORONARY ARTERY (RCA). THERE WAS NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED, THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE WAS USED DURING DELIVERY. THE GUIDE (AL2) WAS NOT ENGAGED WELL, NO SUPPORT, AND STENT HAD TO PASS THROUGH A PREVIOUSLY DEPLOYED STENT STARTING PROXIMALLY. THE STENT GOT STUCK ON A STENT STRUT OF AN OLD STENT. AN ATTEMPT WAS MADE TO PUT A 2.0MM BALLOON THROUGH THE STENT AND INFLATED THE BALLOON. AFTER DEFLATING THE BALLOON AND PULLING IT OUT IT WAS REPORTED THAT THE STENT MAY HAVE STILL BEEN ENGAGED WITH THE OLD STENT AND THE STENT DEFORMED AND DISLODGED FROM THE BALLOON. A SNARE WAS USED TO REMOVED THE STENT FROM THE PATIENT. AFTER THE STENT WAS REMOVED, PATIENT STILL HAD CHEST PAIN OF 8 OF 10. AN ECHO WAS ORDERED AND EKG DID NOT SHOW ANY CHANGES.

  Patient problems: Injury

  MAUDE report 10441390 ↗
• MalfunctionJul 22, 2020Fracture; Material Deformation; Fracture; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL CIRCUMFLEX (CX) 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. IT WAS STATED THAT THE STENT FRACTURED AND THE STENT STRUT WAS LIFTED UP DURING DELIVERY THROUGH THE VESSEL. IT WAS STATED THAT A 6 FRENCH TELESCOPE GUIDE EXTENSION CATHETER AND WIRE DISPLACED AND FAILED TO CROSS WHILE ADVANCING THE STENT AND THE WHOLE SYSTEM BACKED OUT OF THE ARTERY, ON EVALUATION STENT FRACTURE WAS NOTED. THE PROCEDURE WAS COMPLETED USING ANOTHER STENT. 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 10306790 ↗
• MalfunctionJul 21, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE MID RIGHT CORONARY ARTERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION AND A DAMAGED STRUT WAS NOTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10300619 ↗
• MalfunctionApr 14, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT FAILED TO CROSS THE LESION. IT WAS STATED THAT THE STENT GOT CAUGHT UP ON CALCIUM AND BENT WHEN ADVANCING THE DEVICE DURING DELIVERY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9956500 ↗
• InjuryMar 16, 2020Adverse 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 (RONYX22538UX) WAS IMPLANTED IN THE LAD. ONE RESOLUTE ONYX DRUG ELUTING STENT (RONYX22522UX) WAS IMPLANTED IN THE CX DURING A PLANNED STAGED PROCEDURE. ON THE SAME DAY AS THE STAGED PROCEDURE THE PATIENT SUFFERED IN-STENT CORONARY ARTERY RESTENOSIS TREATED WITH REVASCULARIZATION OF THE LAD (CASS 13). THE PATIENT RECOVERED. THE INVESTIGATOR 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. CEC ADJUDICATED THE REVASCULARIZATION AS NO EVENT AND COMMENTED "NO CHANGE. STAGED PROCEDURE WITH PLAQUE SHIFT FROM OSTIAL LCX AND DISTAL LEFT MAIN TO OSTIAL LAD PROMPTING RESCUE OF LAD." SAFETY COMMENTED ISR.

  Patient problems: Injury; Occlusion; Stenosis

  MAUDE report 9835794 ↗
• MalfunctionJan 30, 2020Fracture; Device Dislodged or Dislocated; Material Deformation; Fracture; Device Dislodged or Dislocated; Material Deformation

  A 2.25 X 30 RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT (PLI10) WAS USED TO TREAT A SEVERELY CALCIFIED, MILDLY TORTUOSITY LESION EXHIBITING 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WAS NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED. EXCESSIVE FORCE WAS NOT USED. AN ATTEMPT WAS THEN MADE TO DELIVER A 2.25 X 38 MM RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT (PLI20) THROUGH A PROXIMAL 2.25 X 30 RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT (PLI10) TO A DISTAL LESION THE STENT COULD NOT PASS THE PROXIMAL STENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE 2.25 X 38MM DEVICE (PLI20). THE 2.25 X 38MM DEVICE WAS INSPECTED WITH NO ISSUES, NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE 2.25 X 38 RESOLUTE STENT (PLI 20) DEFORMED INSIDE THE 2.25 X 30 RESOLUTE ONYX RX STENT (PLI 10). DURING REMOVAL OF THE 2.25 X 38MM DEFORMED STENT (PLI20) IT CAUGHT ON THE 2.25 X 30MM STENT (PLI10) AND THE 2.25 X 30MM STENT (PLI10) DISLODGED. BOTH STENTS WERE SNARED IN THE AORTA AND REMOVED. THE LESION WAS THEN TREA

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9646355 ↗
• MalfunctionNov 27, 2019Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DES TO TREAT A MILDLY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE PROXIMAL CX. 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 NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL STENTS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9382990 ↗
• DeathOct 24, 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 11 MONTHS POST PROCEDURE, PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE AND ANTI PLATELET MEDICATION.

  Patient problems: Death

  MAUDE report 9233501 ↗
• 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 8673973 ↗
• InjuryFeb 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT DURING A PROCEDURE. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE DISLODGED STENT WAS REMOVED USING A SNARE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8347034 ↗
• MalfunctionFeb 14, 2019Material Deformation; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE MID RCA. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER 2.25X38 RESOLUTE ONYX STENT. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338562 ↗
• InjuryDec 21, 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. APPROX 7 DAYS POST INDEX PROCEDURE, THE PATIENT SUFFERED ACUTE NSTEMI. THE NSTEMI WAS CAUSED BY STENT THROMBOSIS. THE PATIENT WAS TREATED WITH BALLOON ANGIOPLASTY OF THE LAD. THE PATIENT RECOVERED. THE INVESTIGATOR ASSESSED THE EVENT AS UNLIKELY RELATED TO THE INDEX DEVICE BUT CAUSALLY RELATED TO ANTI-PLATELET MEDICATION. SAFETY ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND CAUSALLY RELATED TO ANTI-PLATELET MEDICATION.

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

  MAUDE report 8188861 ↗
• MalfunctionOct 2, 2018Material Deformation; Material Deformation

  IT WAS REPORTED ON A NO CROSS FORM THAT ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A LESION IN THE MID LAD. THE LESION WAS PREDILATED. THE STENT FAILED TO CROSS THE LESION AND IN DOING SO WAS DAMAGED. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED INSTEAD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925775 ↗
• InjuryJul 10, 2018Break; Detachment of Device or Device Component; Device Dislodged or Dislocated

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A 2.25 X 38MM RESOLUTE ONYX DEVICE TO TREAT A MODERATELY TORTUOUS AND CALCIFIED LESION WITH 90% STENOSIS LOCATED IN THE PROXIMAL TO MID LAD. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES REMOVING THE DEVICE FROM THE HOOP. 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. EXCESSIVE FORCE WAS USED. SIMULTANEOUSLY, A 2.25 X 12MM ONYX DEVICE WAS DELIVERED THROUGH A 6F LAUNCHER GUIDE CATHETER (EBU375) TO TREAT A LESION IN THE FIRST DIAGONAL. THE 2.25 X 12MM DEVICE WAS DELIVERED TO THE TARGET LESION FIRST AND THEN THE 2.25 X 38MM WAS ATTEMPTED TO BE DELIVERED TO THE PROXIMAL TO MID LAD LESION. DURING DELIVERY THE 2.25 X 38MM DEVICE BECAME WEDGED IN THE CALCIFIED MID LAD. WHEN AN ATTEMPT WAS MADE TO WITHDRAW THE DEVICE THE STENT DISLODGED. THE DISLODGED STENT WAS DILATED (USING A 1.5 X 15MM NON-MEDTRONIC BALLOON, A 2.0 X 12MM EUPHORIA BALLOON AND A 2.75 MM NON-MEDTRONIC NC BALLOON) AND DEPLOYED. THE STENT THAT WAS DELIVERED BUT NOT DEPLOYED IN

  Patient problems: Arrhythmia; Bradycardia; Embolism; Foreign Body In Patient; Ischemia; Low Blood Pressure/ Hypotension; Patient Problem/Medical Problem; Thrombus; Vascular Dissection

  MAUDE report 7672884 ↗
• MalfunctionMar 13, 2018Material Deformation; Material Deformation

  THE PHYSICIAN INTENDED TO USE A RESOLUTE ONYX DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID-DISTAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS HEAVILY CALCIFIED AND CSI WAS USED TO REDUCE SOME CALCIUM. 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. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT IS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PROCEDURE WAS COMPLETED USING ANOTHER 2.25X38MM RESOLUTE ONYX DEVICE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333361 ↗
• MalfunctionMar 8, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A 2.25 X 38 MM RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED AND TORTUOUS MID CX LESION EXHIBITING 75% STENOSIS. THE LESION WAS REPORTED TO HAVE BEEN DISSECTED BY A NON-MEDTRONIC WIRE. THERE WAS NO DAMAGE NOTED TO PACKAGING. NO ISSUES REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED AND NEGATIVE PREP PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE, THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO CROSS THE LESION BUT THE DEVICE FAILED TO CROSS. THE PHYSICIAN THEN TRIED USING A 5FR GUIDELINER AND STILL COULD NOT GET THE STENT TO CROSS. DURING REMOVAL THE STENT GOT STUCK IN THE GUIDELINER. IT WAS REPORTED THAT THE STENT DISLODGED. THE STENT WAS REMOVED VIA THE GUIDELINER. THE PHYSICIAN THEN TRIED A 2.25X12 RESOLUTE ONYX DEVICE AND THIS DID NOT CROSS EITHER. THE PROCEDURE WAS COMPLETED. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7322955 ↗
• InjuryMar 6, 2018Adverse 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 LAD. ON THE SAME DAY, POST PROCEDURE, PATIENT SUFFERED MYOCARDIAL INFARCTION. THE CEC ASSESSED EVENT AS NON-Q-WAVE MI TARGET VESSEL (LAD). THE CEC HAS ADJUDICATED THAT THIS IS AN EVENT.

  Patient problems: Myocardial Infarction

  MAUDE report 7316275 ↗
• MalfunctionFeb 13, 2018Material Deformation; Material Deformation

  IT IS REPORTED THAT A RESOLUTE ONYX DRUG ELUTING STENT DEVICE BECAME DAMAGED (STENT STRUT WAS BENT) IN A CALCIFIED CIRCUMFLEX ARTERY; POSITIONING DIFFICULTIES WERE EXPERIENCED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7266098 ↗
• MalfunctionDec 15, 2017Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE PHYSICIAN INTENDED TO USE RESOLUTE ONYX RX DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND SEVERELY CALCIFIED LESION LOCATED BETWEEN THE MID TO PROXIMAL OBTUSE MARGINAL ARTERY, EXHIBITING 90% STENOSIS. THERE WERE NO ABNORMALITIES 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. 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. IT WAS REPORTED THAT THE STENT WAS UNABLE TO PASS MULTIPLE TIMES, ONCE REMOVED AND UPON INSPECTION THE STENT WAS REPORTED TO BE NOT INTACT. IT WAS REPORTED THAT NO PORTION OF THE FRACTURED STENT WAS DETACHED FROM THE REST OF THE STENT. NO OTHER STENT WAS ATTEMPTED TO PASS THROUGH THE LESION. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7120817 ↗