EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R33USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07290107013970), received between May 3, 2018 and Jan 31, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2019Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  THE REPORTED EVENT HAD INVOLVED TWO DEVICES: A 4.0X33 ELUNIR THAT WOULDN'T PASS THROUGH A 5FR SHEATH HAD, TO SOME EXTENT CONTRADICTING FINDINGS, WHERE THE DEVICE (ASSUMING FROM PREVIOUS CASE DETAIL REPORT - STENT) WAS REPORTED AS BROKEN IN THE SHEATH BUT NOT IN TWO OR MORE SEPARATE PIECES, EVENTUALLY CAUSED THE REMOVAL OF THE WHOLE SYSTEM, INCLUDING THE SHEATH AND WIRE. IN THIS CASE, SINCE THE DAMAGED STENT WAS CONFINED BY THE SHEATH THROUGHOUT THE PROCEDURE IT POSED NO THREAT TO PATIENT WELL BEING. AS FOR THE 3.0X33 ELUNIR THAT GOT STUCK ON THE GUIDEWIRE, CAUSING THE PHYSICIAN TO REMOVE EVERYTHING BECAUSE THE STENT WOULD NOT COME OFF - IN LIGHT OF THE NEW INFORMATION RECEIVED ON JAN 6TH, INDICATING EXCESSIVE FORCE WAS IN USE, THE EVENT WAS RE-ASSESSED AND CLASSIFIED AS FDA REPORTABLE. INITIAL CASE REPORT (RECEIVED FROM CORDIS, DEC 30, 2018): STENT GOT STUCK ON WIRE. DOCTOR REMOVED EVERYTHING BECAUSE STENT WOULD NOT COME OFF WIRE. ADDITIONAL INFORMATION RECEIVED FROM CORDIS ON JAN 1, 2019: AS REPORTED, 4.0X33 ELUNIR STENT WOULD NOT PASS THROUGH A 5FR SHEATH. THE DOCTOR PUSHED, AND THE STENT BROKE IN THE SHEATH. A 3.0X33 ELUNIR STENT GOT STUCK ON THE WIRE. THE DOCTOR REMOVED EVERYTH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8292019 ↗
• MalfunctionJul 26, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  INITIAL COMPLAINT, RECEIVED ON JULY 01, 2018: PHYSICIAN DEPLOYED A 3.0 X 33 ELUNIR THROUGH 6 FRENCH FEMORAL ACCESS, WORKING OVER A SCION BLUE WIRE IN CIRCUMFLEX ARTERY. THE ARTERY WAS TORTUOUS WITH MODERATE CALCIFICATION AND SHARP BEND. AFTER THE STENT WAS DEPLOYED, THE PHYSICIAN POST DILATED WITH THE STENT BALLOON. THE STENT BALLOON THEN WOULD NOT COME OUT. AFTER PULLING NEGATIVE SEVERAL TIMES AND THEN USING SALINE, THE PHYSICIAN WAS ABLE TO REMOVE THE CATHETER. THE STENT WAS DEPLOYED AND THE PATIENT WAS FINE. UPON INSPECTION OF THE SCRUB AT THE TABLE, IT WAS NOTICED THAT THE STAINLESS STEEL TIP WAS MISSING FROM THE END OF THE CATHETER. THE PHYSICIAN LOOKED UNDER FLOURO AND DIDN'T SEE IT. THE PHYSICIAN ALSO DID IVUS EXAMINATION OF THE VESSEL AS WELL, BUT HE WAS UNABLE TO LOCATE THE TIP IN THE ARTERY. ADDITIONAL INFORMATION, RECEIVED ON JULY 15, 2018: THERE WAS NO REPORTED PRODUCT ISSUE DURING THE DEPLOYMENT OF THE STENT. THE STENT WAS NOTED TO BE FULLY APPOSED ON IVUS, HOWEVER, THERE IS NO ASSURANCE THAT THE OPERATOR WAS ABLE TO REACH THE DISTAL SEGMENT. THERE WAS NO REPORTED PRODUCT ISSUE WITH THE GUIDEWIRE USED. THE PATIENT WAS NOT SYMPTOMATIC AS A RESULT OF THE REPORTED PRODUCT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7722003 ↗
• MalfunctionMay 3, 2018Positioning Failure; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation; Positioning Failure; Failure to Advance; Deformation Due to Compressive Stress; Material Deformation

  COMPLAINT OUTSIDE US. ADDITIONAL INFORMATION RECEIVED: DEVICE ANALYSIS REPORT (JUNE 10, 2018) - SEE ATTACHED. IFU REVIEW (JUNE 11, 2018) - SEE ATTACHED. FINAL REPORT (JUNE 13, 2018) - SEE ATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482398 ↗