Resolute OnyxRecalls & reported problems across all models
Medtronic, Inc. · 101 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,211
- Deaths reported
- 180
- Injuries reported
- 1,273
- Recalls
- 0
We found 101 models of Resolute Onyx by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 2,211 adverse event reports in the FDA's MAUDE database, received between Jun 19, 2017 and Sep 30, 2026 — classified as 180 deaths, 1,273 injuries, 758 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (612 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Resolute Onyx problems
Device problems
- Adverse Event Without Identified Device or Use Problem989
- Device Dislodged or Dislocated612
- Material Deformation563
- Detachment of Device or Device Component59
- Activation, Positioning or Separation Problem50
- Burst Container or Vessel45
- Inflation Problem42
- Device Damaged by Another Device37
Patient problems
- No Consequences Or Impact To Patient496
- Myocardial Infarction467
- No Clinical Signs, Symptoms or Conditions296
- Insufficient Information174
- Patient Problem/Medical Problem170
- Death140
- Occlusion135
- Injury128
Resolute Onyx models
101 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- Resolute Onyx™ RONYX30022UXCoronary drug-eluting stent6 deaths76 reports
- Resolute Onyx™ RONYX30015UXCoronary drug-eluting stent3 deaths73 reports
- Resolute Onyx™ RONYX25015UXCoronary drug-eluting stent5 deaths67 reports
- Resolute Onyx™ RONYX30012UXCoronary drug-eluting stent5 deaths66 reports
- Resolute Onyx™ RONYX30018UXCoronary drug-eluting stent8 deaths64 reports
- Resolute Onyx™ RONYX22512UXCoronary drug-eluting stent3 deaths63 reports
- Resolute Onyx™ RONYX25018UXCoronary drug-eluting stent5 deaths63 reports
- Resolute Onyx™ RONYX25038UXCoronary drug-eluting stent4 deaths62 reports
- Resolute Onyx™ RONYX22515UXCoronary drug-eluting stent2 deaths61 reports
- Resolute Onyx™ RONYX25012UXCoronary drug-eluting stent8 deaths58 reports
- Resolute Onyx™ RONYX30026UXCoronary drug-eluting stent6 deaths57 reports
- Resolute Onyx™ RONYX35015UXCoronary drug-eluting stent6 deaths54 reports
- Resolute Onyx™ RONYX25022UXCoronary drug-eluting stent3 deaths52 reports
- Resolute Onyx™ RONYX35018UXCoronary drug-eluting stent6 deaths52 reports
- Resolute Onyx™ RONYX30030UXCoronary drug-eluting stent3 deaths49 reports
- Resolute Onyx™ RONYX22518UXCoronary drug-eluting stent5 deaths46 reports
- Resolute Onyx™ RONYX20012UXCoronary drug-eluting stent3 deaths45 reports
- Resolute Onyx™ RONYX25026UXCoronary drug-eluting stent2 deaths40 reports
- Resolute Onyx™ RONYX35012UXCoronary drug-eluting stent2 deaths40 reports
- Resolute Onyx™ RONYX20030UXCoronary drug-eluting stent2 deaths39 reports
- Resolute Onyx™ RONYX30038UXCoronary drug-eluting stent5 deaths37 reports
- Resolute Onyx™ RONYX40018UXCoronary drug-eluting stent2 deaths36 reports
- Resolute Onyx™ RONYX27538UXCoronary drug-eluting stent3 deaths34 reports
- Resolute Onyx™ RONYX35038UXCoronary drug-eluting stent3 deaths34 reports
- Resolute Onyx™ RONYX20015UXCoronary drug-eluting stent3 deaths33 reports
- Resolute Onyx™ RONYX25030UXCoronary drug-eluting stent4 deaths32 reports
- Resolute Onyx™ RONYX27515UXCoronary drug-eluting stent3 deaths32 reports
- Resolute Onyx™ RONYX30034UXCoronary drug-eluting stent6 deaths32 reports
- Resolute Onyx™ RONYX22522UXCoronary drug-eluting stent2 deaths31 reports
- Resolute Onyx™ RONYX27518UXCoronary drug-eluting stent3 deaths31 reports
- Resolute Onyx™ RONYX40015UXCoronary drug-eluting stent2 deaths31 reports
- Resolute Onyx™ RONYX20018UXCoronary drug-eluting stent30 reports
- Resolute Onyx™ RONYX22526UXCoronary drug-eluting stent4 deaths30 reports
- Resolute Onyx™ RONYX35026UXCoronary drug-eluting stent2 deaths30 reports
- Resolute Onyx™ RONYX35022UXCoronary drug-eluting stent1 death28 reports
- Resolute Onyx™ RONYX22530UXCoronary drug-eluting stent3 deaths27 reports
- Resolute Onyx™ RONYX27526UXCoronary drug-eluting stent3 deaths25 reports
- Resolute Onyx™ RONYX27522UXCoronary drug-eluting stent1 death24 reports
- Resolute Onyx™ RONYX20022UXCoronary drug-eluting stent3 deaths23 reports
- Resolute Onyx™ RONYX22538UXCoronary drug-eluting stent1 death23 reports
- Resolute Onyx™ RONYX30008UXCoronary drug-eluting stent2 deaths23 reports
- Resolute Onyx™ RONYX35030UXCoronary drug-eluting stent2 deaths22 reports
- Resolute Onyx™ RONYX22508UXCoronary drug-eluting stent3 deaths21 reports
- Resolute Onyx™ RONYX25034UXCoronary drug-eluting stent3 deaths21 reports
- Resolute Onyx™ RONYX27508UXCoronary drug-eluting stent1 death21 reports
- Resolute Onyx™ RONYX40038UXCoronary drug-eluting stent1 death21 reports
- Resolute Onyx™ RONYX22534UXCoronary drug-eluting stent20 reports
- Resolute Onyx™ RONYX27512UXCoronary drug-eluting stent1 death19 reports
- Resolute Onyx™ RONYX27530UXCoronary drug-eluting stent2 deaths18 reports
- Resolute Onyx™ RONYX20008UXCoronary drug-eluting stent2 deaths17 reports
- Resolute Onyx™ RONYX40022UXCoronary drug-eluting stent2 deaths17 reports
- Resolute Onyx™ RONYX40030UXCoronary drug-eluting stent1 death17 reports
- Resolute Onyx™ RONYX25008UXCoronary drug-eluting stent16 reports
- Resolute Onyx™ RONYX40008UXCoronary drug-eluting stent2 deaths16 reports
- Resolute Onyx™ RONYX40012UXCoronary drug-eluting stent6 deaths15 reports
- Resolute Onyx™ RONYX40026UXCoronary drug-eluting stent1 death15 reports
- Resolute Onyx™ RONYX20026UXCoronary drug-eluting stent14 reports
- Resolute Onyx™ RONYX35034UXCoronary drug-eluting stent1 death14 reports
- Resolute Onyx™ RONYX50012UXCoronary drug-eluting stent2 deaths13 reports
- Resolute Onyx™ RONYX35008UXCoronary drug-eluting stent12 reports
- Resolute Onyx™ RONYX45018UXCoronary drug-eluting stent8 reports
- Resolute Onyx™ RONYX45012UXCoronary drug-eluting stent7 reports
- Resolute Onyx™ RONYX45026UXCoronary drug-eluting stent7 reports
- Resolute Onyx™ RONYX50015UXCoronary drug-eluting stent1 death7 reports
- Resolute Onyx™ RONYX30012WCoronary drug-eluting stent7 reports
- Resolute Onyx™ RONYX27534UXCoronary drug-eluting stent1 death6 reports
- Resolute Onyx™ RONYX50018UXCoronary drug-eluting stent1 death6 reports
- Resolute Onyx™ RONYX50030UXCoronary drug-eluting stent6 reports
- Resolute Onyx™ RONYX45022UXCoronary drug-eluting stent1 death5 reports
- Resolute Onyx™ RONYX25012WCoronary drug-eluting stent5 reports
- Resolute Onyx™ RONYX30018WCoronary drug-eluting stent1 death5 reports
- Resolute Onyx™ RONYX45030UXCoronary drug-eluting stent1 death4 reports
- Resolute Onyx™ RONYX22526WCoronary drug-eluting stent4 reports
- Resolute Onyx™ RONYX27515WCoronary drug-eluting stent4 reports
- Resolute Onyx™ RONYX30015WCoronary drug-eluting stent4 reports
- Resolute Onyx™ RONYX30038WCoronary drug-eluting stent4 reports
- Resolute Onyx™ RONYX40034UXCoronary drug-eluting stent3 reports
- Resolute Onyx™ RONYX50022UXCoronary drug-eluting stent3 reports
- Resolute Onyx™ RONYX35012WCoronary drug-eluting stent3 reports
- Resolute Onyx™ RONYX35018WCoronary drug-eluting stent3 reports
- Resolute Onyx™ RONYX45015UXCoronary drug-eluting stent1 death2 reports
- Resolute Onyx™ RONYX22515WCoronary drug-eluting stent2 reports
- Resolute Onyx™ RONYX25015WCoronary drug-eluting stent2 reports
- Resolute Onyx™ RONYX25022WCoronary drug-eluting stent2 reports
- Resolute Onyx™ RONYX30022WCoronary drug-eluting stent2 reports
- Resolute Onyx™ RONYX30026WCoronary drug-eluting stent2 reports
- Resolute Onyx™ RONYX35026WCoronary drug-eluting stent2 reports
- Resolute Onyx™ RONYX50026UXCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX20012WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX20018WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX22508WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX22518WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX22522WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX25008WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX25026WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX25030WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX27512WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX27522WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX27526WCoronary drug-eluting stent1 report
- Resolute Onyx™ RONYX30034WCoronary drug-eluting stent1 report
Recent Resolute Onyx adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Difficult to Remove; Device Damaged by Another Device; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation
Percutaneous coronary intervention (PCI) procedure on the right coronary artery (RCA) was performed via right radial access to treat obstructive RCA disease. The lesion being treated was mildly tortuous, mildly calcified, with 75% stenosis located in the proximal Right Coronary Artery (RCA). The lesion was noted to be eccentric, irregular and ulcerative. The was a previously deployed stent present. There was a severe plaque burden detected. A guide catheter was inserted, and the guidewire was advanced distal to the lesion. Angioplasty was performed prior to stent deployment. A 3.0 x 12 mm Euphora balloon was inflated to a maximum pressure of 16 ATM for a maximum of 20 seconds. Another 3.0 x 12 mm Euphora balloon was inflated to a maximum pressure of 14 ATM for a maximum of 20 seconds. A 4.0 x 38 mm Resolute Onyx coronary drug eluting stent (DES) was successfully advanced and deployed in the midlesion. The 4.0 x 38 mm Resolute Onyx stent was then advanced to treat the proximal lesion with overlap. The device was inspected prior to use with no issues. Negative prep was not performed. The device did not pass through a previously deployed stent. There was resistance encountered when ad
Patient problems: Foreign Body Embolism; Hemorrhage/Blood Loss/Bleeding; Obstruction/Occlusion
MAUDE report 50944401 ↗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 ↗MalfunctionMar 20, 2026Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED AFTER REMOVAL FROM THE PATIENT. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24647224 ↗MalfunctionMar 3, 2026Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX CORONARY BALLOON AND ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT. THE TARGET LESION WAS LOCATED IN THE OSTIUM OF THE TP TRUNK VESSEL WHICH EXHIBITED MODERATE TORTUOSITY, MILD CALCIFICATION AND 65% STENOSIS. THE NC EUPHORA COULD NOT LOAD ONTO THE GUIDEWIRE. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE DEVICE WAS NOT USED IN THE PATIENT. THE RESOLUTE ONYX STENT DISLODGED IN VIVO DURING DELIVERY TO/AT LESION. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE DEVICE DID PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DE LIVERY. THE DISLODGED STENT REMAINED PARTIALLY ON THE BALLOON. THE STENT AND BALLOON WERE REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24494604 ↗InjuryJan 12, 2026Activation, Positioning or Separation Problem
ANGIOGRAPHY PERFORMED ON A PATIENT WHICH NOTED THAT THE PATIENT HAD A LEFT MAIN (LM) HAD DIFFUSE MILD NON OBSTRUCTIVE CORONARY ARTERY DISEASE. THE LEFT ANTERIOR DESCENDING ARTERY (LAD) HAD 60-70% SMOOTH CALCIFIED MID LAD DISEASE. THE DISTAL VESSEL HAD DIFFUSE MILD DISEASE. THE FIRST DIAGONAL (D1) BRANCH HAD 80-90% NARROWING THROUGHOUT THE OSTIAL AND PROXIMAL VESSEL. THE LEFT CIRCUMFLEX (LCX) GAVE RISE TO A LARGE TORTUOUS FIRST OBTUSE MARGINAL AND CONTINUED IN THE AV GROOVE AS A DIMINUTIVE VESSEL. THERE WAS MODERATE PROXIMAL LCX DISEASE FOLLOWED BY FOCAL MID VESSEL CALCIFIED LESION AND 95% OM1 CALCIFIED LESION. THE RIGHT CORONARY ARTERY HAD 40% DISEASE FOLLOWED BY FOCAL 80% MID VESSEL LESION. THE DISTAL VESSEL HAD DIFFUSE MILD DISEASE. THE PATIENT HAD SEVERE CORONARY ARTERY DISEASE INVOLVING THE LCX , MID LAD, OSTIAL TO PROXIMAL D1 AND MID RCA. GIVEN THE 3 VESSEL CAD, THE DECISION WAS MADE TO PERFORM A PCI TO THE MORSE SEVERE LESION, THE LCX. THE LEFT CORONARY ARTERY WAS ENGAGED WITH A 6F EBU3.5 GUIDE CATHETER. A NON MEDTRONIC WIRE WAS ADVANCED BEYOND THE CULPRIT LESION BY PLACING IT DISTALLY IN THE TORTUOUS OBTUSE MARGINAL WITHOUT COMPLICATION. A 2.5 MM BALLOON WAS POSITIONED ACROS
Patient problems: Atrial Fibrillation; Dyspnea; Ischemia; Obstruction/Occlusion
MAUDE report 24035843 ↗DeathDec 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT WAS IMPLANTED DURING A PROCEDURE. APPROXIMATELY 4 YEARS LATER THE PATIENT DIED OF HEART FAILURE. IT IS UNKNOWN IF THE STENT WAS OCCLUDED.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 23862193 ↗InjuryDec 18, 2025Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT, DIFFICULTY WAS ENCOUNTERED ADVANCING STENT. THE GUIDE WIRE CAME BACK FROM ACROSS LESION AND WHILE REPOSITIONING, THE STENT CAME LOOSE FROM DELIVERY SYSTEM. ALL WIRES AND CATHETERS WERE IMMEDIATELY REMOVED, BUT THE STENT COULD NOT BE LOCATED VISUALLY OR VIA FLUOROSCOPY IN THE CATHETER. IT IS BELIEVED THAT THE DISLODGED STENT TRAVELED TO UNKNOWN LOCATION IN BODY SUCH AS THE HEAD OR NECK. THE STENT COULD NOT BE FOUND. THE PATIENT HAS HAD ISSUES SINCE THE EVENT AND IS CURRENTLY INTUBATED IN THE ICU. THE LESION BEING TREATED WAS IN THE CIRCUMFLEX ARTERY (CX). 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 BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. THE PATIENT IS ALIVE WITH INJURY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 23838373 ↗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 ↗MalfunctionSep 5, 2025Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated; Entrapment of Device; Device Damaged by Another Device; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG-ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. THE LESION BEING TREATED WAS SEVERELY CALCIFIED LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THE DEVICE WAS REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22975594 ↗InjuryAug 29, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX CORONARY DRUG-ELUTING STENT, THE STENT DISLODGED DURING DELIVERY TO THE LESION. BALLOON ANGIOPLASTY WAS PERFORMED AND THE STENT WAS IMPLANTED. THE LESION BEING TREATED WAS MODERATELY TORTUOUS AND MODERATELY CALCIFIED LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE DEVICE PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22920694 ↗InjuryAug 20, 2025Migration or Expulsion of Device; Migration or Expulsion of Device
DURING A PROCEDURE, ONE RESOLUTE ONYX DES WAS SUCCESSFULLY IMPLANTED IN THE SEVERELY STENOSED LEFT ANTERIOR DESCENDING ARTERY (LAD). APPROXIMATELY 22 MONTHS LATER, THE PATIENT HAD SEVERE ESOPHAGUS PAIN, AND THE NEXT DAY ATTENDED HOSPITAL WHERE THE PATIENT WAS DIAGNOSED WITH A HEART ATTACK. THE PATIENT WAS SENT TO THE CARDIOLOGY UNIT AND HAD SOME ARTERIES CLEANED OUT AND MEDTRONIC STENTS WERE IMPLANTED. APPROXIMATELY ONE MONTH LATER THE PATIENT ATTENDED AN OUT-PATIENT APPOINTMENT WHERE MORE WORK WAS CARRIED OUT. THE PATIENT THEN HAD ROUTINE 6-MONTH CHECKUPS. APPROXIMATELY 40 AND 17 MONTHS RESPECTIVELY POST MEDTRONIC STENT IMPLANTATION THE PATIENT SUFFERED SEVERE PAIN ACROSS THE TOP OF THEIR CHEST. THE PATIENT WAS HOSPITALIZED WITH ACUTE MYOCARDIAL INFARCTION. THE PATIENT CONTINUED TO HAVE CHEST PAIN WHICH WAS SIMILAR TO THE PREVIOUS MYOCARDIAL INFARCTION (MI). AN ECG WAS SHOWING ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE (RVR). THE PATIENT UNDERWENT A PROCEDURE WHERE IT WAS REPORTED THAT THE IMPLANTED MEDTRONIC STENTS HAD DISLODGED, FALLING ACROSS THE ARTERY AND BLOCKING THE BLOOD FLOW. THE PROBLEM WAS CORRECTED DURING THE PROCEDURE. IT WAS NOTED THAT A 2.25 X 18MM NON-MEDT
Patient problems: Atrial Fibrillation; Cardiac Arrest; Chest Pain; Diaphoresis; Dizziness; Dyspnea; Myocardial Infarction; Obstruction/Occlusion; Ventricular Fibrillation
MAUDE report 22849789 ↗InjuryJun 24, 2025Device Dislodged or Dislocated; Material Deformation; Positioning Problem; Device Dislodged or Dislocated; Material Deformation; Positioning Problem
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE RESOLUTE ONYX STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO OR AT THE LESION. THERE WAS SEVERE TORTUOSITY AND SEVERE CALCIFICATION IN THE MID SEGMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DISLODGED STENT WAS REMOVED FROM THE PATIENT USING A SNARE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22317557 ↗InjuryMay 30, 2025Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem; Device Damaged by Another Device; Device Dislodged or Dislocated; Positioning Problem
IT WAS REPORTED THAT DURING A COMPLEX PERCUTANEOUS CORONARY INTERVENTION, ONE RESOLUTE ONYX CORONARY DRUG ELUTING STENT FAILED TO CR OSS THE LESION. THE LESION WAS CALCIFIED AND IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. A NON-MEDTRONIC GUIDE EXTENSION CATHETER (GEC) WAS USED TO ADVANCE THE STENT TO THE LESION. THE STENT FAILED TO CROSS THE LESION AND WHEN PULLING THE STENT BACK INTO THE GEC, THE STENT CAME OFF THE DELIVERY CATHETER/BALLOON. THE STENT WAS SUBSEQUENTLY JAILED USING ANOTHER STENT. THE PATIENT IS DOING WELL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 22113909 ↗MalfunctionMar 18, 2025Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Device Contamination with Chemical or Other Material; Material Deformation; Positioning Problem; Improper or Incorrect Procedure or Method; Deformation Due to Compressive Stress; Device Contamination with Chemical or Other Material; Material Deformation; Positioning Problem
IT WAS REPORTED THAT ONE RESOLUTE ONYX OTW CORONARY DRUG ELUTING STENT FAILED TO CROSS THE LESION. THE LESION BEING TREATED WAS NON-CALCIFIED LESION, MILDLY TORTUOUS WITH 0% STENOSIS, IN THE OSTIUM OF THE PATENT DUCTUS ARTERIOSUS (PDA). THE PROCEDURE AIMED TO STENT THE ENTIRE LENGTH OF THE PDA TO ALLOW THE INFANT PATIENT TO GROW BEFORE UNDERGOING HEART REPAIR SURGERY AT A LATER DATE. THE DEVICE WAS INSPECTED PRIOR TO USE, AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT 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 DETAILED THAT THE STENT COULD NOT ADVANCE TO THE SITE BECAUSE THE PLASTIC PIECE ON THE BALLOON CATHETER WOULD NOT RETRACT FULLY TO THE HUB. THE DEVICE WAS REMOVED FROM THE PATIENT AND AN ATTEMPT WAS MADE TO TRY AND REMOVE THE PLASTIC PIECE OVER THE STENT; HOWEVER, IT WOULD NOT COME OFF AND THE ATTEMPT LED TO THE STENT KINKING. THE STENT WAS DAMAGED AFTER IT WAS REMOVEDFROM THE BODY AND ATTEMPTS WERE MADE TO REMOVE THE PLASTIC PIECE. THE DEVICE WAS THEN UNUSABLE. IT WAS STATED THAT THE PLASTIC PIECE WAS NOT THE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21630436 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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