EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R24USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290107013567), received between Mar 20, 2018 and Jul 25, 2018 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 25, 2018Retraction Problem; Retraction Problem

  PTCA AND STENTING WAS PERFORMED ON RAMUS VESSEL. TREK 2.25X24 PTCA BALLOON WAS USED TO PRE DILATE VESSEL OVER A CHOICE PT FLOPPY WIRE WITH NO COMPLICATIONS. ELUNIR 2.5X24 WAS ADVANCED TO LESION AND STENT WAS DEPLOYED. AFTER DEPLOYMENT, PHYSICIAN STATED THE DEPLOYMENT PTA BALLOON WAS STUCK. PHYSICIAN STATED THERE WAS RESISTANCE WITHDRAWING THE PTA BALLOON CAUSING CORDIS XB 3.5 GUIDE TO DEEP SEAT AND THE CHOICE WIRE TO ADVANCE FURTHER INTO VESSEL. PHYSICIAN WAS ABLE TO REMOVE BALLOON WITH NO COMPLICATIONS OR HARM TO PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7718232 ↗
• MalfunctionMay 31, 2018Difficult to Advance; Difficult to Advance

  PHYSICIAN INSERTED STENT DELIVERY SYSTEM ON WIRE AND COULD NOT CROSS ONCE AT THE LESION. WHEN THE PHYSICIAN ATTEMPTED TO TAKE THE STENT CATHETER OFF THE WIRE, IT WOULD NOT COME OFF SO THE PHYSICIAN WAS REQUIRED TO TAKE BOTH THE WIRE AND STENT OFF SIMULTANEOUSLY. INFORMATION RECEIVED ON MAY. 07, 2018: THE DEVICE PROBLEM OCCURRED DURING THE PROCEDURE IN PATIENT. THERE WAS NO INJURY TO PATIENT. ADDITIONAL DATA RECEIVED ON MAY 09, 2018: THE PRODUCT WAS STORED AND PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DAMAGE TO THE PRODUCT PACKING NOTICED PRIOR TO USE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCT FROM THE PACKAGING. THERE WERE NO ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED. THERE WAS ADEQUATE CONTINUOUS FLUSH MAINTAINED THROUGH ALL DEVICES. IT WAS VERIFIED PRIOR TO INSERTION THAT THE STENT WAS CONTAINED WITHIN THE OUTER SHEATH/INTRODUCER OF THE SYSTEM. THE GUIDEWIRE PORT WAS FLUSHED AS OUTLINED IN THE IFU PRIOR TO LOADING ON THE GUIDEWIRE. THE DEVICE WAS REMOVED INTACT (IN ONE PIECE) FROM THE PATIENT. ADDITIONAL DATA RECEIVED ON MAY. 10, 2018: THE PHYSICIAN USED EXCESSIVE FORCE WHILE TRYING TO CROSS THE LESION. THE GUIDE WIRE WAS USED FOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556727 ↗
• InjuryMar 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PHYSICIAN DEPLOYED THE FIRST STENT (2.5X12) IN THE MID CIRCUMFLEX ARTERY. HE DID NOT POST DILATE THE STENT, AFTER STENT PLACEMENT. THE STENT PLACEMENT WAS OVER A BEND. BOTH THE LAD AND CIRCUMFLEX HAD SUBSTANTIAL DISEASE THROUGH OUT. HE THEN WANTED TO STENT THE DISTAL CIRCUMFLEX ARTERY. AS HE TRIED TO PASS THE 2.5X24MM STENT THROUGH THE FIRST STENT, HE MANAGED TO STRIP THE SECOND STENT OFF THE CATHETER. THE TWO STENTS WERE BOTH RETRIEVED WITH A SNARE. PATIENT IS STABLE NOT WITH A PARTIALLY OPEN CIRCUMFLEX. THE CIRCUMFLEX BEFORE THE INTERVENTION HAD ABOUT 70% BLOCKAGE. ADDITIONAL INFORMATION RECEIVED ON FEB 28, 2018. THE LENGTH OF THE LESION WAS AT LEAST 36MM. THE SITE WAS PREDILATED PRIOR TO STENT IMPLANTATION. THERE WAS DIFFUSE DISEASE. THE STENT THAT WAS DISLODGED WASN'T MANIPULATED DURING PREP. SHEATH: 6FR. GUIDE CATHETER SIZE: 6FR GUIDE JL4. THE BALLOON WASN'T PARTIALLY INFLATED. THE INFLATION DEVICE WAS IN THE NEGATIVE POSITION WHILE BEING ADVANCED AND REMOVED. STATUS OF THE PATIENT: STABLE. THE TARGET LESION WAS NOT SUCCESSFULLY TREATED.

  Patient problems: No Consequences Or Impact To Patient; Stenosis

  MAUDE report 7353054 ↗