Onyx Frontier™ ONYXNG20018UXRecalls & reported problems
Medtronic, Inc. · STENT ONYXNG20018UX ONYX 2.00X18RX · Class 3 · Implant
All models of Onyx Frontier (71)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 16
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00763000511142), received between Oct 6, 2022 and Nov 10, 2025 — classified as 8 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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.
Reports received per month
Most reported problems
Device problems
- Device Dislodged or Dislocated12
- Material Deformation4
- Positioning Problem3
- Detachment of Device or Device Component2
- Device Damaged by Another Device2
- Deformation Due to Compressive Stress1
- Difficult to Open or Remove Packaging Material1
- Entrapment of Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions11
- Insufficient Information7
- Device Embedded In Tissue or Plaque4
Recent adverse event reports
The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.
InjuryNov 10, 2025Deformation Due to Compressive Stress; Device Dislodged or Dislocated; Deformation Due to Compressive Stress; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT, STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WHICH EXHIBITED MILD TORTUOSITY, MILD CALCIFICATION AND 60-70% STENOSIS. THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE STENT WAS PASSED THROUGH THE NON MEDTRONIC GUIDE EXTENSION CATHETER WITH NO PROBLEMS. IT WAS NOTED THAT THE STENT HAD SLID OFF WHEN IT WAS BEING POSITIONED IN THE ARTERY. THE STENT WAS SUCCESSFULLY REMOVED FROM THE PATIENT USING A SNARE. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE AND EXCESSIVE FORCE WAS NOT USED DURING DEVICE ADVANCEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23511004 ↗InjuryJan 23, 2025Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
IT WAS REPORTED THAT DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS LESION WITH 60-70% STENOSIS IN THE PROXIMAL CIRCUMFLEX (CX) ARTERY WHEN THE BALLOON DETACHED DURING DELIVERY THROUGH THE VESSEL. THE DETACHED PORTION OF THE DEVICE REMAINED IN THE PATIENT AFTER AN UNSUCCESSFUL ATTEMPT TO REMOVE THE STENT WITH A SNARE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED PRIOR TO USE WITH NO ISSUES. THE LESION HAD BEEN 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. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 21217271 ↗MalfunctionOct 4, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem
AN ATTEMPT WAS MADE TO USE TWO ONYX FRONTIER CORONARY DRUG ELUTING STENTS TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION IN THE MID OBTUSE MARGINAL (OM). THE DEVICES WERE INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED ON BOTH DEVICES WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICES DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHILE ADVANCING BOTHDEVICES. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT FOR BOTH DEVICES. IT WAS DETAILED THAT BOTH DEVICES COULD NOT CROSS THE LESION, AND ABNORMAL DAMAGE WAS VISUALIZED UPON REMOVAL. THE DAMAGE TO STENT STRUTS WHICH OCCURRED AFTER FAILURE TO CROSS WAS ATYPICAL. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20366400 ↗InjuryJul 4, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. 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 DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. THE STENT CAME OFF THE BALLOON AND STAYED IN THE GUIDE CATHETER. THE DEVICE WAS REMOVED WITH A SEPARATE BALLOON THAT WAS USED TO ADVANCE PAST THE STENT AND PULL IT OUT. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.
Patient problems: Insufficient Information
MAUDE report 19674327 ↗InjuryFeb 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION WITH 100% CHRONIC TOTAL OCCLUSION (CTO) IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS DETAILED THAT THE DISLODGED STENT WAS REMOVED WITH A SNARE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.
Patient problems: Insufficient Information
MAUDE report 18690818 ↗MalfunctionDec 1, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. RESISTANCE WAS NOT NOTED DURING WITHDRAWAL OF THE DEVICE. IT WAS REPORTED THAT THE STENT WAS UNABLE TO CROSS/POSITION THE LESION AND WAS REMOVED. THE LESION WAS PRE-DILATED WITH A DIFFERENT BALLOON. THE STENT BALLOON WAS THEN RE-INSERTED. UNDER FLUOROSCOPY IT WAS NOTICED THAT THE STENT WAS NOT ON THE BALLOON. THE STENT BALLOON WAS REMOVED TO BE EVALUATED AND NO STENT WAS FOUND ON IT. EVERYWHERE AROUND THE PATIENT WAS SEARCHED AS WELL AS X-RAYING THE WHOLE PATIENT AREA THAT THE BALLOON STENT TRAVELED AS WELL AS THE WHOLE CHEST AREA. IT IS UNKNOWN WHERE THE STENT IS. THE PATIENT DID NOT HAVE ANY COMPLICATIONS. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18246809 ↗InjuryOct 13, 2023Device Damaged by Another Device; Device Dislodged or Dislocated; Device Damaged by Another Device; Device Dislodged or Dislocated
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO THE LESION. IT WAS BELIEVED THAT THE STENT DISLODGED GOING THROUGH A NON-MEDTRONIC 5F GUIDE EXTENSION CATHETER (GEC). THE DISLODGED STENT WAS NOT REMOVED AND WAS DEPLOYED IN THE LAD. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17928994 ↗MalfunctionOct 10, 2023Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) 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 ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT LESION. THE DISLODGED STENT WAS REMOVED WITH THE STENT DELIVERY SYSTEM. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17908461 ↗InjuryOct 10, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MILDLY TORTUOUS, MODERATELY CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. 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. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING DELIVERY TO/AT THE LESION. IT WAS DETAILED THAT THE STENT WAS NOT REMOVED BUT THAT THE DISLODGED STENT WAS BALLOONED IN PLACE. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.
Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information
MAUDE report 17905299 ↗InjurySep 25, 2023Device Dislodged or Dislocated; Positioning Problem; Device Dislodged or Dislocated; Positioning Problem
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER DRUG ELUTING STENT (DES) TO TREAT A LESION LOCATED IN THE CIRCUMFLEX (CX) ARTERY. THERE WAS DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. IT WAS REPORTED THAT THE STENT COULD NOT CROSS VIA THE PREVIOUSLY DEPLOYED STENTS. THE STENT DISLODGED FOLLOWING THE FAILED DELIVERY OF THE DEVICE. WHEN THE STENT WAS BEING REMOVED IT WAS NOTED THAT THE STENT HAD COME OFF OF THE STENT BALLOON AT THE MOUTH OF THE GUIDE. THE STENT WAS SAFELY SNARED AND REMOVED WITH A SMALL BALLOON. THE PATIENT IS ALIVE, WITH NO INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17805916 ↗MalfunctionAug 29, 2023Entrapment of Device; Device Damaged by Another Device; Material Deformation; Entrapment of Device; Device Damaged by Another Device; Material Deformation
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG-ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION IN THE DISTAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE NON-MEDTRONIC GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE. THERE WERE NO ISSUES/KINKS NOTED. THERE WERE NO DIFFICULTIES NOTED WHEN LOADING THE DEVICE ONTO THE GUIDEWIRE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING THE DELIVERY. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO POST-STENT DEPLOYMENT. IT WAS DETAILED THAT FOLLOWING INFLATION OF THE STENT AT NOMINAL PRESSURE, THE STENT WAS DEPLOYED. AN ATTEMPT WAS MADE TO REMOVE THE NON-MEDTRONIC GUIDEWIRE WHICH WAS CAUGHT ON THE DISTAL STENT STRUTS. THE GUIDE WIRE WAS ONLY USED WITH THE STENT PRIOR TO THE ISSUE OCCURRING. MULTIPLE ATTEMPTS WERE MADE TO REMOVE THE GUIDE WIRE. THE STENT WAS DEFORMED IN THE ATTEMPT TO REMOVE THE GUIDEWIRE. THE 3MM TIP OF THE GUIDEWIRE BROKE OFF. THE DETACHED PORTION OF THE GUIDEWIR
Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions
MAUDE report 17640117 ↗MalfunctionMay 24, 2023Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A LESION. IT WAS REPORTED THAT WHEN THE STENT WAS ADVANCED OVER THE INTERVENTIONAL WIRE AND THROUGH THE HEMOSTASIS VALVE THE SHAFT BENT AND BROKE. THE STENT BECAME LOST WHEN REMOVED OFF THE FIELD. BOTH PARTS OF THE STENT SHAFT WERE SAVED. THE STENT WAS REPLACED WITH A NEW STENT. THE STENT CAUSED NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16993356 ↗MalfunctionJan 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A TORTUOUS, CALCIFIED LESION WITH 80% STENOSIS LOCATED IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. THE DEVICE WAS PREPPED PER IFU. THE PROTECTIVE SHEATH WAS REMOVED WITHOUT RESISTANCE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT OR CELL OF A STENT. SOME RESISTANCE WAS NOTED ADVANCING THE DEVICE. NO EXCESSIVE FORCE WAS USED. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE CX ARTERY AND WAS REMOVED FROM THE BODY. THE LESION WAS THEN PRE-DILATED WITHOUT ISSUE. HOWEVER, IT WAS THEN NOTED THAT THERE WAS NO STENT ON THE STENT DELIVERY SYSTEM. A FLUOROSCOPY OF THE PATIENT, THE SHEATH AND THE GUIDE WAS PERFORMED BUT THE STENT COULD NOT BE SEEN. THE STERILE FIELD WAS SEARCHED BUT THE STENT WAS NOT FOUND. A LITTLE RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE DEVICE, BUT EXCESSIVE FORCE WAS NOT USED. ANOTHER STENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE WITH NO PROBLEMS. THE PATIENT WAS WELL AND WENT HOME THE SAME DAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16094527 ↗MalfunctionOct 26, 2022Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A LESION. 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 WITH 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT WHEN AN ATTEMPT WAS MADE TO REMOVE THE STYLET FROM THE TIP OF THE ONYX FRONTIER STENT, RESISTANCE WAS ENCOUNTERED. ON FURTHER INSPECTION, IT WAS NOTED THAT THE PLASTIC TIP APPEARED MELTED. AFTER THE STYLET WAS REMOVED, THE DEVICE WAS INSPECTED AGAIN AND PROCEEDED WITH THE PERCUTANEOUS CORONARY INTERVENTION (PCI). IT WAS STATED THAT THERE WAS NO AFFECT TO PATIENT AT ANY TIME. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15672875 ↗MalfunctionOct 18, 2022Material Deformation; Material Deformation
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER 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 PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15623582 ↗InjuryOct 6, 2022Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated
AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION EXHIBITING 80-90% STENOSIS LOCATED IN THE PROXIMAL OBTUSE MARGINAL (OM). THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT STENT EMBOLIZATION OCCURRED. IT WAS STATED THAT A 6 FR 3.5 NON-MEDTRONIC GUIDE CATHETER WAS USED AND THE LESION COULDN'T BE CROSSED AT THE DISTAL OM. FORCE WAS NOT USED. THE STENT CATHETER WAS PULLED BACK AND IT WAS NOTICED THAT THERE WAS NO STENT ON THE DELIVERY SYSTEM. UNDER A FLUOROSCOPY, THE STENT WAS FOUND AT THE PROXIMAL PART OF THE VESSEL. A 1.5 BALLOON WAS USED TO ATTEMPT TO DEPLOY THE STENT HOWEVER THE BALLOON COULD NOT GET INTO IT THE STENT. A 0.014 WIRE WAS THEN ADVANCED AND THERE WAS AN ATTEMPT TO CRUSH THE STENT TO THE VESSEL WALL USING A 2.0 BALLOON, HOWEVER THE BALLOON DID NOT CROSS AND THE STENT MIGRATED TO THE DISTAL PART OF OM VESSEL. THERE WAS AN ATTEMPT TO SNARE THE STENT BUT AFTER MANIPULATING THE WIRE, IT WAS NOTICED THAT THE TIP OF THE WIRE GOT SEPARATED AND IT WAS FLOATING FREELY AT THE MOST DISTAL PART OF THE VESSEL. THE STENT RELOCATED TO THE PROXIMAL PART OF THE VESSEL AGAIN. IT W
Patient problems: Insufficient Information
MAUDE report 15549043 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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