Resolute Onyx™ RONYX30022UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 76 adverse event reports that list this exact device (DI 00643169557000), received between Sep 14, 2017 and Jan 20, 2023 — classified as 6 deaths, 52 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (17 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 76 reports, in the reporter's own words as published by the FDA.

• InjuryJan 20, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE 3.0 X 22MM RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT (DES) TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT DISLODGEMENT OCCURRED IN VIVO. INITIALLY, THE SEVERELY STENOSED PROXIMAL OBTUSE MARGINAL (OM2) LESION WAS ADDRESSED WITH A 2.5 X 8MM RESOLUTE ONYX DES, USING DOUBLE INFLATION TECHNIQUE. THEN, THERE WAS GREAT DIFFICULTY ADVANCING ANOTHER STENT INTO THE PROXIMAL LCX DUE TO THE SEVERE CALCIFICATION AND TORTUOSITY. ULTIMATELY, THE 3.0 X 22MM RESOLUTE ONYX DES WAS DELIVERED, BUT THERE WERE SOME CONCERNS. THERE APPEARED TO BE A GAP BETWEEN THE PROXIMAL STENT MARKER AND ABOUT ONE-THIRD DOWN THE STENT BALLOON PRIOR TO DEPLOYMENT, BUT IT WAS THOUGHT TO REFLECT ¿ACCORDION LIKE¿ EFFECT WITH THE DIFFICULT STENT DELIVERY. THE STENT WAS DEPLOYED WITH GREAT RESULT. THE STENT BALLOON WAS REMOVED. THERE WAS T

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

  MAUDE report 16213272 ↗
• InjurySep 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY AND IT WAS STATED TO BE TORTUOUS. 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 THOUGH 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 WHEN TRYING TO PULL BACK THE STENT INTO A NON MDT GUIDE EXTENSION CATHETER FOLLOWING A FAILED DELIVERY. A NEW 2.0MM BALLOON WAS INSERTED THROUGH THE STENT AND IT WAS INFLATED TO 3 ATM. THE DISLODGED STENT, BALLOON, CATHETER AND THE WIRE WERE REMOVED SIMULTANEOUSLY THROUGH THE GUIDE CATHETER. THE DISLODGED STENT WAS REMOVED SUCCESSFULLY WITH NO PATIENT ISSUE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15462318 ↗
• InjuryApr 12, 2022Device 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 NON-TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 90% STENOSIS LOCATED IN THE PROXIMAL LEFT MAIN (LM) CORONARY 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. THE DISLODGED STENT WAS NOT REMOVED FROM THE PATIENT AND WAS CRUSHED INTO VESSEL WALL. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 14083047 ↗
• InjuryDec 14, 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, MODERATELY CALCIFIED LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE 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 BUT EXCESSIVE FORCE WAS NOT USED.  IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL OF THE DEVICE FOLLOWING A FAILED DELIVERY, IN WHICH THE STENT FAILED TO CROSS THE LESION MULTIPLE TIMES. THE DISLODGEMENT OCCURRED AT THE OSTIUM OF THE RCA. THE STENT WAS SNARED AND PULLED BACK TO THE FEMORAL ACCESS SITE BUT THE STENT CAME OFF THE SNARE AND LODGED IN THE SUBCUTANEOUS TISSUE. THE STENT REMAINS IN THE PATIENT. NO FURTHER PATIENT INJURY REPORTED.

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

  MAUDE report 12999742 ↗
• MalfunctionNov 3, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX DRUG ELUTING STENTS TO TREAT A LESION IN THE MID RCA AND THE SAPHENOUS VEIN GRAFT (SVG). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT REMOVAL DIFFICULTIES OCCURRED FOLLOWING STENT DEPLOYMENT. IT WAS ALSO REPORTED THAT THE CATHETER/DELIVERY SYSTEM OF THE FIRST RESOLUTE ONYX STENT WAS DEFORMED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12743660 ↗
• InjuryOct 4, 2021Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A LESION. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED IN VIVO DURING DELIVERY TO THE LESION. THE DISLODGED STENT REMAINED ON THE WIRE IN THE VESSEL AND THE WIRE POSITION WAS NEVER LOST. THE STENT WAS RECROSSED AND A POST DILATATION BALLOON WAS USED TO TACK THE STENT INTO POSITION. IT WAS ALSO REPORTED THAT DEVICE REMOVAL DIFFICULTIES WERE ENCOUNTERED PRIOR TO STENT DEPLOYMENT. PATIENT WAS STABLE AND TRANSFERRED TO RECOVERY. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12568669 ↗
• InjuryJul 19, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A PROCEDURE PROMPTED BY STEMI, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT AND ONE TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A MODERATELY TORTUOUS AND MODERATELY CALCIFIED LESION IN THE MID CX ARTERY. THERE WAS NO ALLEGED ISSUE WHEN USING THE TELESCOPE GEC. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE STENT WAS CRUSHED TO THE VESSEL WALL WITH ANOTHER ONYX STENT 3.00 X 18MM. THE PATIENT IS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12187602 ↗
• InjuryJun 25, 2021Fracture; Material Deformation; Fracture; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS AND NONE CALCIFIED LESION IN THE PROXIMAL-MID RCA WITH 99% STENOSIS. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO POST DEPLOYMENT. THE STENT WAS POST-DILATED TO 3.5MM AT HIGH PRESSURE WITH NO ISSUES. POST CINE IMAGING SHOWED A POSSIBLE STENT FRACTURE IN THE MID STENT. A NON MEDTRONIC STENT WAS DEPLOYED OVER THE FRACTURED SECTION OF DEPLOYED RESOLUTE ONYX AND POST DILATED TO 3.5MM. THE PATIENT IS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12065341 ↗
• InjuryMay 28, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE 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 BUT EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE STENT WAS REMOVED VIA A SNARE. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11899636 ↗
• InjuryMar 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DRUG ELUTING STENT WERE IMPLANTED IN THE LAD AND ONE RESOLUTE ONYX DRUG ELUTING STENT WAS IMPLANTED IN THE LCMA. APPROXIMATELY 5 DAYS POST PROCEDURE PATIENT SUFFERED GASTROINTESTINAL BLEED. GI BLEEDING WAS SUSPECTED AS THE PATIENT HAD BLACK STOOLS AND GENERALIZED WEAKNESS. THE PATIENT WAS ON DAPT 24 HOURS PRIOR TO THE EVENT. THE EVENT WAS TREATED WITH BLOOD TRANSFUSION, MEDICATION AND SURGICAL PROCEDURE. PATIENT RECOVERED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11552311 ↗
• DeathFeb 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 LAD AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST RPL. APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11357563 ↗
• InjuryFeb 17, 2021Device 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 95% STENOSIS LOCATED IN THE MID 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 DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING A FAILED DELIVERY. IT WAS STATED THAT THE STENT WAS REMOVED FROM THE PATIENT AS THE STENT DISLODGED INSIDE THE GUIDE. A SECOND WIRE WAS INTRODUCED THROUGH THE GUIDE PAST THE DISLODGED STENT. THE GUIDE WAS PULLED OUT OF THE BODY AND THE STENT WAS INSIDE THE GUIDE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11336642 ↗
• 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 11320713 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE 2 RESOLUTE ONYX WERE IMPLANTED IN THE RCA. TWO EUPHORA AND ONE NC EUPHORA PTCA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. APPROXIMATELY ONE DAY POST INDEX PROCEDURE, PATIENT'S CARDIO BIOMARKER WERE ELEVATED. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MI INVOLVING THE RCA. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO ANTIPLATELET MEDICATION BUT POSSIBLY RELATED TO INDEX DEVICE. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 10885420 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE INDEX PROCEDURE TWO RESOLUTE ONYX DES, TWO EUPHORA AND ONE NC EUPHORA PTCA BALLOONS WERE USED TO TREAT THE RCA. APPROXIMATELY 20 DAYS LATER, DURING A STAGED PROCEDURE ONE RESOLUTE ONYX DES WAS USED TO TREAT THE LAD. THE SAME DAY POST STAGED PROCEDURE PATIENT SUFFERED ELEVATED TROPONIN. THE INVESTIGATOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE INDEX DEVICE AND NOT TO THE ANTI-PLATELET MEDICATION AND THE PATIENT RECOVERED. CEC ADJUDICATED THAT APPROXIMATELY 20 DAYS POST STAGE PROCEDURE, PATIENT SUFFERED A TARGET VESSEL MYOCARDIAL INFARCTION INVOLVING THE LAD.

  Patient problems: Myocardial Infarction

  MAUDE report 10884468 ↗
• InjuryNov 19, 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 R-PDA. FIVE NC EUPHORA AND ONE SPRINTER LEGEND PTCA BALLOONS WERE ALSO USED DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT PATIENT'S CARDIAC ENZYMES WERE ELEVATED ON THE SAME DAY POST INDEX PROCEDURE. CEC ADJUDICATED THE EVENT AS TARGET VESSEL MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 10867100 ↗
• DeathOct 2, 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 RAMUS. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE, PATIENT DIED (UNKNOWN CAUSE).

  Patient problems: Death; Renal Failure

  MAUDE report 10618609 ↗
• InjurySep 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING AN INDEX PROCEDURE THREE RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENTS WERE IMPLANTED IN THE PROX RCA, OB MARG AND THE DISTAL CX. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A FEW EPISODES OF BLOODY STOOLS AND STRAINED TO PASS STOOLS. DAPT WAS TAKEN WITHIN 24 HOURS PRIOR TO THE EVENT. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE AND UNLIKELY RELATED TO THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE ANTIPLATELET MEDICATION AND NOT RELATED TO THE DEVICE. THE PATIENT IS RECOVERING/RESOLVING.

  Patient problems: Blood Loss; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 10475657 ↗
• 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 10447198 ↗
• MalfunctionJul 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING THE PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND SEVERELY CALCIFIED LESION, LOCATED IN THE DISTAL RIGHT CORONARY ARTERY. THERE WERE NO ABNORMALITIES 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 WITHNO ISSUES IDENTIFIED. 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 USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS DESCRIBED THAT THE STENT WAS SEEN ON THE WIRE OUTSIDE OF THE PATIENT WHEN THE WIRE WAS BEING WIPED. IT WAS INFORMED THAT THE STENT WAS ON THE BALLOON WHEN THE GUIDE WAS INSIDE THE PATIENT. THE GUIDE WAS NOT REMOVED FROM THE BODY UNTIL THE END OF THE CASE. IT IS BELIEVED THAT STENT DISLODGEMENT OCCURRED OUTSIDE OF THE BODY IN THE CO-PILOT DURING REMOVAL FROM THE GUIDE HUB. PATIENT STATUS POST-PROCEDURE IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10263394 ↗
• MalfunctionMay 12, 2020Material Deformation; Material Deformation

  A RESOLUTE ONYX DRUG-ELUTING STENT WAS INTENDED TO BE USED DURING A PROCEDURE TO TREAT A LESION IN THE PROXIMAL RCA, EXHIBITING MODERATE TORTUOSITY AND MODERATE CALCIFICATION. THE LESION WAS 100% OCCLUDED (CTO). NO DAMAGE WAS NOTED TO DEVICE PACKAGING AND THE DEVICE WAS INSPECTED WITHOUT ISSUES NOTED. THE LESION WAS PRE-DILATED AND THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT THE PHYSICIAN ADVANCED THE STENT TO THE LESION AREA AND IT WAS NOTED THAT STENT STRUTS HAD LIFTED. THE STENT WAS THEN RETRACTED FOR FURTHER INSPECTION. THE LIFTED STENT STRUTS WERE OBSERVED, SO A NEW STENT WAS THEN USED TO SUCCESSFULLY TREAT THE LESION. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10046099 ↗
• 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. CEC ADJUDICATED THAT THE PATIENT SUFFERED MI (TARGET VESSEL) AND SLOW FLOW IN THE 1ST DIAGONAL DURING PROCEDURE.

  Patient problems: Myocardial Infarction

  MAUDE report 9847286 ↗
• InjuryMar 4, 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 IN THE LAD AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM GI BLEED . EVENT WAS TREATED WITH BLOOD TRANSFUSION. PATIENT WAS NOT ON DAPT 24 HOURS PRIOR TO EVENT. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE, BUT PROBABLY RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Blood Loss

  MAUDE report 9785983 ↗
• InjuryFeb 21, 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 LAD. APPROXIMATELY 8 MONTHS POST PROCEDURE, PATIENT SUFFERED DARK TARRY STOOLS AND ASA MEDICATION WAS STOPPED. PATIENT WAS ON DAPT 24 HOURS PRIOR TO EVENT. PATIENT RECOVERED. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO DEVICE BUT POSSIBLY RELATED TO ANTI PLATELET MEDICATION.

  Patient problems: Blood Loss

  MAUDE report 9738261 ↗
• MalfunctionFeb 20, 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, ONE TELESCOPE GUIDE EXTENSION CATHETER, AND ONE LAUNCHER TO TREAT A TORTUOUS AND CALCIFIED LESION LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING INSERTION INTO THE HOMEOSTATIC VALVE. IT WAS STATED WHEN THE DEVICE CAME OUT OF THE CORONARIES THE STENT WAS STILL ON THE BALLOON. IT WAS REPORTED THAT THE TELESCOPE WAS OUT OF THE GUIDE WIRE. IT WAS STATED THAT WHEN THE STENT CAME OFF THE BALLOON AT THE DISTAL END OF THE TELESCOPE. ALL DEVICES WERE REMOVED INCLUDING THE WIRE. THE STENT WAS NOT SEEN IN THE GUIDE OR TELESCOPE AND WAS FOUND IN THE TOUEY. THE STENT WAS FOUND WHEN A NEW GUIDE WIRE WAS ADVANCED AND RESISTANCE WAS FELT. IT WAS STATED THAT THE TELESCOPE COULD BARELY ENTER THE LEFT MAIN AND THE TELESCOPE TIP MAY HAVE GOTTEN DISTORTED. THE PROCEDURE WAS COMPLETED USING A NEW GUIDE, NEW WIRE, NEW TELESCOPE AND A NEW RESOLUTE ONYX STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9732541 ↗