EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R33USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107013666), received between May 3, 2018 and Jan 13, 2019 — classified as 2 malfunctions.

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

• MalfunctionJan 13, 2019Material Deformation; Material Deformation

  INITIAL CASE REPORT (RECEIVED FROM CORDIS, DEC 16, 2018): PRIOR TO USE IN THE PATIENTS, 3 BALLOONS WOULD NOT DEFLATE. A NOTIFICATION RECEIVED FROM CORDIS ON DEC 18, 2018 CLARIFIED THAT THE COMPLAINT WAS NOT AS INITIALLY REPORTED BUT AS DETAILED BELOW: "THE COMPLAINT ISSUE WAS A "NO CROSS", BUT WHEN THE STENT WAS REMOVED FROM THE PATIENT, A STENT STRUT WAS STICKING UP FROM THE STENT MID SHAFT. IT WAS FRACTURED. IT WAS NEVER ATTEMPTED TO BE INFLATED. THE PATIENT WAS NOT HARMED IN ANYWAY." UPDATED CASE REPORT (RECEIVED FROM CORDIS DEC 18, 2018): AS REPORTED BY SALES REP: THE ISSUE I HAD WITH THE COMPLAINT I SUBMITTED WAS IT WAS A "NO CROSS", BUT WHEN THE STENT WAS REMOVED FROM THE PATIENT, A STENT STRUT WAS STICKING UP FROM THE STENT MID SHAFT. IT WAS FRACTURED. IT WAS NEVER ATTEMPTED TO BE INFLATED. THE PATIENT WAS NOT HARMED IN ANYWAY. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ELUNIR SUCCESSFULLY. UPDATED CASE REPORT (RECEIVED FROM CORDIS DEC 31, 2018): AS REPORTED, AN ELUNIR STENT DELIVERY SYSTEM (2.75X33 US) WOULD NOT CROSS THE LESION. UPON REMOVAL FROM THE PATIENT, A STENT STRUT WAS FOUND TO BE FRACTURED AND STICKING UP MID-STENT. THERE WERE NO ATTEMPTS MADE TO INFLATE THE BALLO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8243014 ↗
• MalfunctionMay 3, 2018Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION RECEIVED ON APR. 29, 2018: THE % STENOSIS OF THE DISTAL LAD WAS 80%, OF THE MIDDLE LAD WAS 85%, AND OF THE PROXIMAL LAD WAS 85%. THE TARGET LESION WAS MODERATELY CLASSIFIED, AND THERE WAS NO TORTUOSITY. THE PATIENT WAS NOT SYMPTOMATIC AT ALL AS A RESULT OF THE REPORTED PRODUCT ISSUE. 14 ATM WERE USED IN DEPLOYING EACH STENT; THERE WAS NO REPORTED DIFFICULTY ADVANCING THE SDSS TO THE INTENDED TARGET LESION; THERE WAS NO REPORTED DIFFICULTY CROSSING THE TARGET LESIONS. THE PRODUCT WAS STORED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU); NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING UPON INSPECTION PRIOR TO USE; NO DIFFICULTY WAS NOTED DURING REMOVAL OF THE PRODUCT FROM THE PACKAGING; THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEAR TO BE NORMAL; THE PRODUCT WAS PREPPED PROPERLY, ACCORDING TO THE IFU; THERE WERE NO PROBLEMS NOTED DURING PREPARATION. ADDITIONAL INFORMATION RECEIVED ON MAY 1, 2018: BMW GUIDE WIRE WAS USED; PRE-DILATION WAS PERFORMED. THE DEFLATION TIME WAS ABOUT 7-10 SECONDS; POST DILATION WAS PERFORMED; GUIDE LINER OR OTHER GUIDE EXTENSION SYSTEM WERE NOT USED; BUDDY-WIRE WAS NOT USED; ALL THREE BALLOONS BEHAVED IN SAME WAY. AFTER STENTS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7482213 ↗