Resolute Onyx™ RONYX35038UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00643169557130), received between Oct 10, 2017 and Jan 12, 2024 — classified as 3 deaths, 13 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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 34 reports, in the reporter's own words as published by the FDA.

• InjuryJan 12, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED LESION. IT WAS REPORTED THAT THE BALLOON DETACHED DURING REMOVAL OF THE DEVICE. THE STENT WAS IMPLANTED. NO PATIENT INJURY REPORTED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18501631 ↗
• InjuryAug 18, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, MODERATELY TORTUOUS LESION WITH 80% STENOSIS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED BEFORE USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE.  IT WAS REPORTED THAT WHILE TRYING TO PASS THE STENT THROUGH A PREVIOUSLY IMPLANTED STENT THE CATHETER SHAFT KINKED. WHILE TRYING TO REMOVE THE STENT THE SHAFT FRACTURED. THE DETACHED PORTION OF THE DEVICE DOES NOT REMAIN IN THE PATIENT AND WAS REMOVED WITH A SNARE. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15248089 ↗
• InjuryJul 28, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A SEVERELY TORTUOUS AND SEVERELY CALCIFIED LESION. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT BOTH STENTS FAILED TO CROSS THE LESION AND DEFORMED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15121667 ↗
• MalfunctionJan 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT. IT WAS REPORTED THAT THE SHAFT BROKE WHEN THE DEVICE WAS INSERTED INTO THE VESSEL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13174010 ↗
• InjuryDec 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE PROXIMAL LEFT MAIN CORONARY ARTERY. 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE STENT DISLODGED OCCURRED DURING DELIVERY. THE DISLODGED STENT WAS REMOVED WITH A SNARE. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 13058931 ↗
• MalfunctionJul 8, 2021Material Deformation; 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 SEVERELY CALCIFIED LESION IN THE MID LAD. 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 DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING THE SAME SIZE RESOLUTE ONYX STENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12133471 ↗
• MalfunctionMar 16, 2021Material Deformation; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE TWO RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11492095 ↗
• DeathFeb 11, 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 RCA. APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM A SUDDEN DEATH. DEATH CLASSIFICATION IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 11312553 ↗
• DeathJan 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 RCA AND ONE RESOLUTE ONYX DES WAS IMPLANTED IN THE CIRCUMFLEX. APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE, PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. [UPDATES UP TO 14 JAN 2021 REVIEWED].

  Patient problems: Insufficient Information

  MAUDE report 11185251 ↗
• InjuryJan 15, 2021Fracture

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. IT WAS REPORTED THAT THE RESOLUTE ONYX STENT WAS DEPLOYED. IT WAS STATED THAT POST PROCEDURE, THE PATIENT WAS STILL HAVING CHEST PAIN AND WAS BROUGHT BACK TO THE CATH LAB. THE FOLLOW UP ANGIOGRAM REVEALED WHAT WAS BELIEVED TO BE A STENT STRUT FRACTURE IN THE MID PORTION OF THE STENT. A 3.5X22MM RESOLUTE ONYX STENT WAS DEPLOYED IN THE PREVIOUSLY DEPLOYED STENT WITH NO FURTHER ISSUES. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO FURTHER INJURIES.

  Patient problems: Chest Pain; Unspecified Tissue Injury

  MAUDE report 11177400 ↗
• MalfunctionJan 12, 2021Material 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 SEVERELY CALCIFIED LESION IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THERE WERE NO ISSUES NOTED DURING INSPECTION OF THE DEVICE AFTER REMOVAL FROM THE PACKAGING. NO ISSUES WERE NOTED WHEN THE DEVICE WAS REMOVED FROM PACKAGING. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PREDILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED AND EXCESSIVE FORCE WAS USED. IT WAS STATED THAT THE PATIENT HAD STEMI FROM THE START OF THIS CASE. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND THE STENT WAS REMOVED. UPON INSPECTION IT WAS NOTED THAT THE STRUTS APPEARED TO BE FRAYED AFTER BEING IN CONTACT WITH THE CALCIUM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11153275 ↗
• DeathSep 25, 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 32 MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM SEPTIC SHOCK AND DIED. INVESTIGATOR AND SAFETY ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION.

  Patient problems: Death; Septic Shock

  MAUDE report 10585174 ↗
• InjuryAug 21, 2020Burst Container or Vessel; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Burst Container or Vessel; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  ONE RESOLUTE ONYX DRUG ELUTING STENT WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY CALCIFIED LESION IN A MODERATELY TORTUOUS VESSEL. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING STENT DEPLOYMENT, BUT IT WAS UNKNOWN WHERE THE BURST/LEAK OCCURRED. THE BALLOON RUPTURE RESULTED IN PARTIAL DEPLOYMENT OF THE STENT. IT WAS STATED THAT THE REMOVAL OF THE RUPTURED BALLOON RESULTED IN STENT DISLODGEMENT OF THE PARTIALLY DEPLOYED STENT AND A CORONARY ARTERY DISSECTION. IT WAS INDICATED THAT STENT DISLODGEMENT OCCURRED AFTER REMOVAL OF THE DEVICE FROM THE PATIENT. NO FURTHER PATIENT INJURY REPORTED. THE PROCEDURE WAS COMPLETED USING ANOTHER RESOLUTE ONYX DEVICE.

  Patient problems: Intimal Dissection; Vascular Dissection

  MAUDE report 10435719 ↗
• MalfunctionAug 10, 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 NOT PERFORMED. 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 STENT. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10384049 ↗
• MalfunctionMay 27, 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. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10091040 ↗
• InjuryMar 23, 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; TWO IN THE RCA AND TWO IN GRAFT 1ST OBTUSE MARGINAL. APPROXIMATELY 9 MONTHS POST PROCEDURE, PATIENT SUFFERED ACUTE CORONARY SYNDROME AND WAS TREATED WITH MEDICATION. THE EVENT IS REPORTED TO BE RELATED TO MYOCARDIAL INFARCTION OF A NON TARGET VESSEL. PATIENT RECOVERED. CEC ADJUDICATED EVENT A NON-Q WAVE MI OF UNKNOWN VESSEL, 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9864772 ↗
• InjuryMar 23, 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; TWO IN THE RCA AND TWO IN GRAFT 1ST OBTUSE MARGINAL. APPROXIMATELY 9 MONTHS POST PROCEDURE, PATIENT SUFFERED ACUTE CORONARY SYNDROME AND WAS TREATED WITH MEDICATION. THE EVENT IS REPORTED TO BE RELATED TO MYOCARDIAL INFARCTION OF A NON TARGET VESSEL. PATIENT RECOVERED. CEC ADJUDICATED EVENT A NON-Q WAVE MI OF UNKNOWN VESSEL, 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9864756 ↗
• MalfunctionJan 3, 2020Material Rupture; Activation, Positioning or Separation Problem

  WHILE ATTEMPTING TO DEPLOY A CORONARY STENT IN TO THE RIGHT CORONARY ARTERY, BALLOON RUPTURED INSIDE STENT BEFORE IT WAS OPENED. PATIENT BECAME HYPOTENSIVE AND BRADYCARDIC REQUIRING IV FLUIDS AND ATROPINE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 9543892 ↗
• InjuryNov 15, 2019Burst Container or Vessel; Burst Container or Vessel

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS USED TO TREAT A MILDLY CALCIFIED, SEVERELY TORTUOUS LESION IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED WITH A NON MEDTRONIC 2.5 X 12 DEVICE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE GUIDE DIDN'T SIT WELL, EVERYTHING WAS TAKEN OUT AND A LAUNCHER GUIDE CATHETER WAS USED WITH A NON MEDTRONIC GUIDE EXTENSION CATHETER. IT WAS REPORTED THAT THE BALLOON RUPTURED AT 12 ATM AND THE STENT DID NOT FULLY EXPAND. A 1.25 X 12 SPRINTER LEGEND DEVICE AND A 2.0 X 12 NON MEDTRONIC DEVICE WERE THEN USED AND THE STENT WAS POST DILATED WITH A 3.5 X 15 NC. THE PATIENT BECAME HYPERTENSIVE AFTER THE RUPTURE AND WAS TRANSPORTED TO CCU. NO OTHER PATIENT INJURY WAS REPORTED.

  Patient problems: High Blood Pressure/ Hypertension

  MAUDE report 9325931 ↗
• InjurySep 16, 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 IMPLANTED IN THE LAD, TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE CIRCUMFLEX AND TWO RESOLUTE ONYX DES WERE IMPLANTED IN THE RCA. APPROXIMATELY 1 DAY POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION OF THE TARGET VESSEL (LAD AND CX). INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTIPLATELETS MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTIPLATELETS MEDICATION. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9069642 ↗
• MalfunctionAug 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A RESOLUTE ONYX RX CORONARY, DRUG ELUTING STENT WAS USED TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT THE STENT BECAME DISLODGED INSIDE THE GUIDE LINER EXTENSION CATHETER DURING DELIVERY TO/AT THE LESION. THE STENT WAS ABLE TO BE RETRIEVED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939001 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT AND A TELESCOPE GUIDE EXTENSION CATHETER WERE USED TO TREAT A SEVERELY CALCIFIED AND TORTUOUS FRIABLE LESION IN THE MID PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. THE TELESCOPE DEVICE WAS PREPPED AS PER IFU, ONYX NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT WHILE BOTH DEVICES WERE ADVANCING A CONTAINED DISSECTION WAS ENCOUNTERED. NO ADDITIONAL PATIENT INJURY.

  Patient problems: Vascular Dissection

  MAUDE report 8797493 ↗
• MalfunctionJun 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A LESION. IT WAS REPORTED THAT THE DEVICE BROKE WHILE ADVANCING INTO THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED USING A NON-MEDTRONIC DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8683067 ↗
• MalfunctionMay 23, 2019Material Deformation; Material Deformation

  DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION LOCATED IN THE MID LAD WITH 90% STENOSIS. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED USING AN NC EUPHORA 3.5 X 20MM BALLOON. 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 DEVICE WAS UNABLE TO CROSS THE LESION AND AFTER IT WAS REMOVED STENT DEFORMATION WAS OBSERVED, STRUTS HAD LIFTED. ANOTHER RESOLUTE ONYX 3.5 X 38MM WAS DEPLOYED WITH NO ISSUES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8635451 ↗
• MalfunctionMar 28, 2019Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE A 3.5X38MM RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 95% STENOSIS LOCATED IN THE PROXIMAL-MID OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITHOUT ISSUE. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO DELIVER THE 3.5X38MM RESOLUTE ONYX STENT TO THE OM USING A GUIDELINER TO FACILITATE THE DELIVERY, HOWEVER THE STENT FAILED TO CROSS THE LESION. WHEN PULLING BACK THE DEVICE THE STENT DISLODGED FROM THE DELIVERY SYSTEM INTO THE VESSEL. THE GUIDELINER WAS ADVANCED OVER THE STENT AND REMOVED OUT OF THE BODY ALONG WITH THE GUIDELINER. AS THIS WAS THE LAST 3.5X38MM RESOLUTE ONYX STENT AVAILABLE, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A 3.5X34MM RESOLUTE ONYX STENT OVERLAPPED WITH ANOTHER RESOLUTE ONYX STENT THAT WAS LATER IMPLANTED IN THE PROXIMALLCX IN ORDER TO MAKE UP FOR THE LENGTH. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8460401 ↗