Resolute Onyx™ RONYX35030UXRecalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00643169557116), received between Feb 26, 2018 and Jan 23, 2024 — classified as 2 deaths, 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO) IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS NOT INSPECTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE TO THE LESION. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION. THE LESION WAS TREATED BY USING A CTO WIRE AND BALLOON TO RE-PREPARE THE LESION. THEN A SAME SIZE RESOLUTE INTEGRITY STENT WAS DEPLOYED WITH NO ISSUES NOTED. THE CASE WAS SUCCESSFUL, AND THE PATIENT IS GOOD. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18561996 ↗
• MalfunctionSep 5, 2022Fracture; Material Deformation; Fracture; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO, DURING POSITIONING/ADVANCEMENT. IT WAS ALSO DETAILED THAT THERE WAS A BROKEN STRUT ISSUE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15355086 ↗
• InjuryOct 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AN ATTEMPT WAS MADE TO USE A RESOLUTE ONYX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY CALCIFIED, MILDLY TORTUOUS LESION, WITH 90% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS NOT INSPECTED. 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 A STENT DISLODGEMENT OCCURRED DURING DELIVERY. AFTER THE STENT WAS PLACED, THE STENT WAS MOVED TO GET BETTER PLACEMENT AND GOT DISLODGED. THE DISLODGED STENT WAS THEN DILATED USING SMALLER BALLOONS. NO FURTHER INJURY WAS REPORTED.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 12604647 ↗
• InjuryApr 12, 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. APPROXIMATELY 20 MONTHS POST PROCEDURE PATIENT SUFFERED OF CHEST PAIN. THE EVENT WAS TREATED WITH MEDICATION AND BLOOD TRANSFUSION. PATIENT RECOVERED. CEC ADJUDICATED THE EVENT AS MYOCARDIAL INFARCTION (UNKNOWN VESSEL).

  Patient problems: Myocardial Infarction

  MAUDE report 11647895 ↗
• MalfunctionApr 7, 2021Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT AND ONE TELESCOPE GUIDE EXTENSION CATHETER TO TREAT A LESION IN THE PROXIMAL OSTIUM OF THE RCA. BOTH DEVICES WERE INSPECTED WITH NO ISSUE NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE TELESCOPE WAS PREPPED PER IFU. 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 THE STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. IT WAS ALSO REPORTED THAT MATING DEVICE ISSUES WERE EXPERIENCE AND THE STENT WAS DEFORMED WHEN TRYING TO ADVANCE THROUGH THE TELESCOPE GEC. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11626335 ↗
• InjuryApr 6, 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 OBTUSE MARGINAL. APPROXIMATELY 14 MONTHS POST PROCEDURE PATIENT SUFFERED VARICELLA PNEUMONIA. THE EVENT WAS TREATED WITH MEDICATION. THE PATIENT DID NOT RECOVER.

  Patient problems: Pneumonia

  MAUDE report 11618048 ↗
• DeathNov 6, 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. APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE, PATIENT DIED. DEATH CLASSIFICATION IS UNKNOWN. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS PROBABLY RELATED TO INDEX DEVICE AND ANTIPLATELET MEDICATION. SPONSOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE INDEX DEVICE, BUT POSSIBLY RELATED TO ANTIPLATELET MEDICATION.

  Patient problems: Cardiogenic Shock; Death

  MAUDE report 10800160 ↗
• 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 9864761 ↗
• InjuryMar 4, 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 WAS IMPLANTED IN THE LAD. APPROXIMATELY 8 MONTHS LATER THE PATIENT SUFFERED MI OF THE LAD (TARGET VESSEL). THE EVENT WAS TREATED WITH HOSPITALIZATION AND AN INTEGRILLIN DRIP WHICH WAS LATER STOPPED. IT WAS REPORTED 100% OCCLUSION OCCURRED IN LAD AND LCX AND RESIDUAL THROMBUS STILL PRESENT AFTER CATH. THE PATIENT RECOVERED. THE INVESTIGATOR AND THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION OR THE DEVICE.

  Patient problems: Myocardial Infarction; Occlusion; Thrombus

  MAUDE report 9784595 ↗
• InjuryFeb 5, 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 THREE IN THE CIRCUMFLEX. APPROXIMATELY TWO MONTHS POST INDEX PROCEDURE, PATIENT SUFFERED FROM MYOCARDIAL INFARCTION OF A NON-TARGET VESSEL. EVENT WAS TREATED WITH CORONARY INTERVENTION. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO INDEX DEVICE OR ANTI-PLATELET MEDICATION. SAFETY ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO INDEX DEVICE, BUT NOT RELATED TO ANTI-PLATELET MEDICATION. PATIENT RECOVERED. CEC ADJUDICATED THE MI END POINT AS NON-Q-WAVE MI (VESSEL UNKNOWN), 3RD UDMI SPONTANEOUS.

  Patient problems: Myocardial Infarction

  MAUDE report 9671011 ↗
• MalfunctionJan 27, 2020Use of Device Problem; Use of Device Problem

  DURING A PROCEDURE A RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT WAS USED TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. RESISTANCE WAS NOT ENCOUNTERED AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT AN EXPIRED STENT WAS IMPLANTED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. NO MEDICAL/SURGICAL INTERVENTION (E.G. PLACED ON ANTIBIOTICS) WAS REQUIRED AS A RESULT OF THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9630961 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE FOUR RESOLUTE ONYX RX CORONARY DRUG ELUTING STENTS WERE IMPLANTED TO TREAT A SEVERELY TORTUOUS, MODERATELY CALCIFIED LESION LOCATED IN THE OSTIUM, PROXIMAL, MID AND DISTAL RIGHT CORONARY ARTERY (RCA). 100% STENOSIS WAS PRESENT. ALL DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED ON ALL FOUR DEVICES WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICES DID PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING ALL FOUR DEVICES BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY OF ANY OF THE DEVICES. IT WAS REPORTED THAT ACUTE STENT THROMBOSIS OCCURRED LESS THAN 24 HOURS POST STENT IMPLANTATION AND AN MI OCCURRED IN RELATION TO THE TARGET VESSEL 7 HOURS POST STENT IMPLANTATION. THE CLOT WAS REMOVED BY ASPIRATION WITH A NON MEDTRONIC DEVICE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: Myocardial Infarction; Thrombus

  MAUDE report 9590993 ↗
• InjuryJan 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, 5 RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; THREE IN THE RCA AND TWO IN THE LAD. THE FOLLOWING DAY, PATIENT SUFFERED ELEVATED CARDIAC ENZYMES WITH NO TREATMENT CARRIED OUT. PATIENT RECOVERED. CEC ADJUDICATED EVENT AS A NON-Q WAVE MI OF THE TARGET VESSEL, 3RD UDMI PERI PCI. CEC ASSESSMENT COMMENTED THAT THERE WAS A LARGE SIDE BRANCH OCCLUSION. INVESTIGATOR ASSESSED THE EVENT IS NOT RELATED TO DEVICE OR ANTI PLATELET. SPONSOR ASSESSED EVENT IS POSSIBLY RELATED TO DEVICE BUT NOT RELATED TO ANTI PLATELET.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 9552202 ↗
• MalfunctionJan 2, 2020Material Deformation; Material Deformation

  DURING A PROCEDURE IT WAS INTENDED TO USE A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT. THERE WAS NO DAMAGE NOTED TO THE PACKAGING AND NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE PROTECTIVE SHEATH ON THE STENT, WHEN THE DEVICE WAS REMOVED FROM HOOP. NO RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE SHEATH. THE SHEATH WAS GRIPPED ON THE MOST DISTAL END OF THE SHEATH DURING REMOVAL FROM OVER THE STENT/BALLOON. THE STENT WAS INSPECTED POST SHEATH REMOVAL WITH NO ABNORMALITIES NOTED. THE STENT WAS NOT HANDLED DIRECTLY POST REMOVAL OF THE SHEATH. IT WAS REPORTED THAT THE STENT WAS NOTICED TO HAVE ISSUES AFTER IT WAS ATTEMPTED TO BE DELIVERED TO THE LESION AND WAS PULLED OUT OF THE BODY. IT WAS REPORTED THAT THE STENT HAD DAMAGE ON ITS END, THE END OF THE STENT WAS NOTED TO HAVE BURRS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9537712 ↗
• InjuryDec 12, 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. APPROXIMATELY 1 MONTH POST PROCEDURE PATIENT SUFFERED CHEST PAIN- NON ISCHEMIC AND WAS HOSPITALIZED AND TREATED WITH MEDICATION. CEC ADJUDICATED MI AS NON Q WAVE MI (VESSEL UNKNOWN), 3RD UDMI SPONTANEOUS. THE INVESTIGATOR ASSESSED THE EVENT AS NOT RELATED TO THE INDEX DEVICE OR THE ANTI-PLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTI-PLATELET MEDICATION AND POSSIBLY RELATED TO THE INDEX DEVICE. THE PATIENT IS RECOVERING.

  Patient problems: Myocardial Infarction

  MAUDE report 9456735 ↗
• InjuryOct 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE INDEX PROCEDURE WAS PROMOTED BY STABLE ANGINA. DURING THE INDEX PROCEDURE ONE RESOLUTE ONYX RX CORONARY DES WAS USED TO TREAT A LESION IN THE RCA. APPROXIMATELY EIGHT MONTHS LATER THE PATIENT SUFFERED A TARGET VESSEL MI. THE PATIENT WAS TREATED WITH STENT TO RCA. PATIENTS MEDICATION WAS DISCONTINUED. THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR TO THE ANTIPLATELET MEDICATION. THE SPONSOR ASSESSED THE EVENT AS NOT RELATED TO THE ANTIPLATELET MEDICATION AND POSSIBLY RELATED TO THE DEVICE. THE PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 9161598 ↗
• MalfunctionAug 20, 2019Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  A RESOLUTE ONYX RX CORONARY DRUG ELUTING STENT WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT A LESION IN THE RCA. IT WAS REPORTED THAT THE STENT WAS UNABLE TO CROSS THE LESION AND WHEN THE STENT WAS PULLED BACK, THE PROXIMAL EDGE OF THE STENT GOT CAUGHT ON THE GUIDE CATHETER. UPON EXAMINATION, IT WAS NOTED THAT THE STENT STRUTS WERE RAISED. NO PATIENT INJURY. THE PROCEDURE WAS COMPLETE USING A 3.5 X 30 MM RESOLUTE ONYX DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8909875 ↗
• 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 8645709 ↗
• InjuryDec 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE FIVE RESOLUTE ONYX DRUG ELUTING STENTS WERE IMPLANTED; FOUR IN THE LAD AND ONE IN THE 1ST DIAGONAL AND TWO NC EUPHORIA BALLOONS WERE USED IN THE LAD. ON THE SAME DAY THE PATIENT SUFFERED ELEVATED TROPONIN AND RECOVERED THE FOLLOWING DAY. CEC ADJUDICATED THE EVENT AS NON-Q WAVE MYOCARDIAL INFARCTION OF THE TARGET VESSEL. INVESTIGATOR ASSESSED EVENT IS UNLIKELY RELATED TO DEVICE AND NOT RELATED TO ANTIPLATELET MEDICATION.

  Patient problems: Myocardial Infarction

  MAUDE report 8150496 ↗
• InjuryJul 20, 2018Adverse Event Without Identified Device or Use Problem

  DURING INDEX PROCEDURE, THREE RESOLUTE ONYX DRUG-ELUTING STENTS WERE IMPLANTED. TWO IN THE RCA AND ONE IN THE IST OM. APPROXIMATELY 12 MONTHS POST PROCEDURE, PATIENT SUFFERED POSSIBLE NSTEMI AND WAS TREATED WITH PCI. INVESTIGATOR ASSESSED EVENT IS NOT RELATED TO THE STUDY DEVICE OR ANTIPLATELET. PATIENT RECOVERED.

  Patient problems: Myocardial Infarction

  MAUDE report 7705611 ↗
• DeathMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INDICATIONS INCLUDED NON-ST ELEVATION AND NON-ACUTE MI. THE PATIENT WAS IN A STATE OF HEART FAILURE WITHIN TWO WEEKS OF THE INITIAL PROCEDURE. FIVE RESOLUTE ONYX DRUG ELUTING STENT DEVICES WERE USED TO TREAT MILDLY TORTUOUS, MODERATELY CALCIFIED LESIONS IN THE PROXIMAL RCA AND MID CIRCUMFLEX ARTERY ((B)(6) 2018). THERE WAS 90% STENOSIS IN THE PROX RCA, 80% STENOSIS IN THE MID RCA, 90% IN THE MID CIRCUMFLEX AND 70% IN THE PROXIMAL CIRCUMFLEX, AND UP TO 99% STENOSIS IN THE DISTAL LAD. THE MID CX LESION SHOWED EVIDENCE OF THROMBUS PRESENCE AND RUPTURED PLAQUE. THE PROCEDURE WAS URGENT. 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 DID NOT PASS THROUGH PREVIOUSLY DEPLOYED STENTS. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICES AND EXCESSIVE FORCE WAS NOT USED. THERE IS NO ALLEGED PRODUCT ISSUE. ONE 3.5X30MM RESOLUTE ONYX STENT, AND ONE NC EUPHORA BALLOON WERE SUCCESSFULLY IMPLANTED IN THE MID CX AT 14 ATM. ONE 4.0X12MM RESOLUTE ONYX STENT WAS SUCCESSFULLY IMPLANTED IN THE PROX CX AT 16 ATM.

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

  MAUDE report 7555916 ↗
• MalfunctionFeb 26, 2018Device Damaged by Another Device; Material Deformation; Device Damaged by Another Device; Material Deformation

  A RESOLUTE ONYX DRUG ELUTING STENT WAS INTENDED TO BE USED TO TREAT A SEVERELY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE OSTIUM OF THE LEFT MAIN CORONARY ARTERY. 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. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS USED. IT IS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING. THE PHYSICIAN WAS POSITIONING THE ONYX FROM THE PROXIMAL LCX TO THE OSTIAL LEFT MAIN. THE LCX TAKEOFF WAS A 140 DEGREE BEND FOLLOWED BY A 90 DEGREE BEND. WHILE ATTEMPTING TO POSITION THE STENT THE PROXIMAL EDGE OF THE STENT WAS LIFTED UP BY THE TIP OF THE GUIDE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER 3.5X30MM ONYX DEVICE. NO PATIENT INJURY IS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7295576 ↗