EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R15USRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07290107013871), received between May 9, 2018 and Dec 12, 2019 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, FOUR DAYS POST STENT IMPLANTATION, PATIENT CAME IN WITH ST ELEVATION MYOCARDIAL INFARCTION (STEMI) DUE TO STENT THROMBOSIS. AS PER THE PHYSICIAN EVALUATION, A 3.5MM X 15MM RIDAFOROLIMUS ELUTING (ELUNIR) STENT APPEARED TO BE ADEQUATELY OPPOSED BUT POSSIBLY UNDER DEPLOYED. THE TARGET LESION WAS THE MID-LEFT ANTERIOR DESCENDING (MLAD) ARTERY WHEREIN THE DEVICE WAS IMPLANTED. A NON-CORDIS STENT WAS PLACED WITHIN THE CURRENT ELUNIR STENT TO REMOVE A POSSIBLE OUTFLOW OBSTRUCTION THAT MAY HAVE CONTRIBUTED TO IN-STENT THROMBOSIS. THERE WAS A POSSIBLE PROXIMAL EDGE DISSECTION THEREFORE, ADDITIONAL LEFT ANTERIOR DESCENDING (LAD) NON-CORDIS STENT WAS PLACED. THE PRODUCT WAS STORED AS PER THE INSTRUCTION FOR USE (IFU). THROMBOSIS TRAVELED TO OBTUSE MARGINALIS (OM1) ARTERY AND CIRCUMFLEX (CIRC) ARTERY THEREFORE, NON-CORDIS STENTS WERE PLACED IN BOTH VESSELS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED.

  Patient problems: Intimal Dissection; Thrombosis

  MAUDE report 9461390 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Positioning Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Positioning Problem; Insufficient Device Problem Information

  CLARIFICATION RECEIVED FROM THE DISTRIBUTOR HAVE STATED: "THE PHYSICIAN KNEW THAT THE STEMI WAS DUE TO IN-STENT THROMBOSIS BASED UPON THE EKG FROM THE STEMI AND THE FACT THE STENT WAS SHUT DOWN."

  Patient problems: Intimal Dissection; Myocardial Infarction; Thrombosis

  MAUDE report 9458540 ↗
• InjuryJul 1, 2018Device Slipped; Device Dislodged or Dislocated; Device Slipped; Device Dislodged or Dislocated

  THE DOCTOR WAS STENTING THE RIGHT CORONARY AND WHILE PLACING THE STENT IT CAME OFF THE BALLOON. THEY TRIED TO PUT ANOTHER BALLOON IN TO PULL IT BACK INTO THE GUIDE BUT THEY WEREN'T ABLE TO DO SO. THEY WERE ABLE TO MOVE THE STENT FORWARD AND PLACE IT SOMEWHAT IN THE AREA THEY WANTED. THE PATIENT WENT HOME OK WITH THE ELUNIR STENT. ADDITIONAL INFORMATION RECEIVED ON JUNE 13TH, 2018: PATIENT IS A MALE, (B)(6) YEARS OLD. THIS WAS THE FIRST TIME THE PHYSICIAN HAD USED ELUNIR STENT SYSTEM AND THE DEVICE WAS PREPARED ACCORDING TO THE IFU. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY IN PREPARATION THE DEVICE. THE TARGET VESSEL WAS THE RIGHT CORONARY ARTERY (RCA), THE PHYSICIAN REACHED THE TARGET SITE ACCESSING THE FEMORAL ARTERY, TARGET VESSEL WAS NOT VERY TORTUOUS AND NOT CALCIFIED MUCH. THE STENT WAS NOT MANIPULATED DURING THE PREPARATION AND WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT AND THERE WAS NO RESISTANCE/FRICTION WHILE INSERTING THE DELIVERY SYSTEM THROUGH THE GUIDE WIRE. NO EXCESSIVE FORCE WAS USED DURING THE PROCEDURE. PRIOR TO SDS INSERT, THE BALLOON WAS NOT INFLATED NOR PA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7653974 ↗
• InjuryJun 7, 2018Migration or Expulsion of Device; Failure to Advance; Device Dislodged or Dislocated; Migration or Expulsion of Device; Failure to Advance; Device Dislodged or Dislocated

  AS REPORTED BY SALES REP.: THE FIRST ELUNIR STENT (3.0 X 28 MM) LOT# LNRUS00080 WOULD NOT CROSS THE MID RCA. AFTER REPEATED ATTEMPTS TO CROSS THE LESION THE ELUNIR SDS WAS RETRACTED BACK INTO THE MEDTRONIC 6F JR4 GUIDE. IT WAS NOTED THE ELUNIR STENT SLIPPED OFF THE STENT DELIVERY BALLOON. THE SDS WAS REMOVED OUT OF THE GUIDE AND A 1.5 BALLOON WAS ADVANCED OVER THE .014 PRO-WATER WIRE AND THROUGH THE UNDEPLOYED ELUNIR. THE ELUNIR WAS REPOSITIONED IN THE PROXIMAL RCA AND DEPLOYED USING THE 1.5 BALLOON. A 2.0 AND 3.0 NC BALLOON WERE USED TO FURTHER DILATE THE ELUNIR. ONCE THE STENT WAS WELL APPOSED TO THE VESSEL WALL THE MD USED A 3.0 X 24 MM ELUNIR DISTAL TO THE 1ST AND 3.0 X 20 MM ELUNIR PROXIMAL. THE CASE WAS ENDED SUCCESSFULLY AND NO CLINICAL COMPLICATIONS WERE NOTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7576850 ↗
• MalfunctionMay 9, 2018Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  ELUNIR WAS DELIVERED AND DEPLOYED IN PATIENT WHEN STENT WAS BEING REMOVED FROM PATIENT FELT SOME RESISTANCE ON WIRE OUTSIDE OF THE BODY. STENT CATHETER WAS REMOVED OVER WIRE. PHYSICIAN THEN WANTED TO USE IVUS TO SEE STENT RESULTS AND AS HE WAS ADVANCING IVUS CATHETER OVER WIRE HE FELT RESISTANCE, HE THEN WIPED WIRE DOWN WITH A WET GAUZE WHILE REMOVING IVUS CATHETER AND NOTICE THE SPRING TIP WAS STILL ON WIRE AND WAS REMOVED WITH HIS GAUZE AS HE WIPED DOWN THE WIRE. THE STENT DEPLOYMENT WAS STRAIGHT FORWARD AND THERE WERE NEVER ANY FORCEFUL MOVEMENTS WITH STENT DELIVERY SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7497933 ↗