EluNIR Ridaforolimus Eluting Coronary Stent SystemRecalls & reported problems across all models

We found 27 models of EluNIR Ridaforolimus Eluting Coronary Stent System by Medinol Ltd. in the FDA's device registry (GUDID). Together they are named in 59 adverse event reports in the FDA's MAUDE database, received between Mar 20, 2018 and Mar 30, 2020 — classified as 3 deaths, 25 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (19 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported EluNIR Ridaforolimus Eluting Coronary Stent System problems

EluNIR Ridaforolimus Eluting Coronary Stent System models

27 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R33US

  Coronary Drug-Eluting Stent
  1 death6 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R15US

  Coronary Drug-Eluting Stent
  5 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R24US

  Coronary Drug-Eluting Stent
  4 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R20US

  Coronary Drug-Eluting Stent
  3 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R24US

  Coronary Drug-Eluting Stent
  3 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R12US

  Coronary Drug-Eluting Stent
  1 death3 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R20US

  Coronary Drug-Eluting Stent
  3 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R33US

  Coronary Drug-Eluting Stent
  3 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R17US

  Coronary Drug-Eluting Stent
  1 death2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R33US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R17US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R20US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R24US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN350R28US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN400R15US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN400R20US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN400R24US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R28US

  Coronary Drug-Eluting Stent
  2 reports
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R12US

  Coronary Drug-Eluting Stent
  1 report
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R15US

  Coronary Drug-Eluting Stent
  1 report
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN250R33US

  Coronary Drug-Eluting Stent
  1 report
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R12US

  Coronary Drug-Eluting Stent
  1 report
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R15US

  Coronary Drug-Eluting Stent
  1 report
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R17US

  Coronary Drug-Eluting Stent
  1 report
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN275R20US

  Coronary Drug-Eluting Stent
  1 report
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN300R15US

  Coronary Drug-Eluting Stent
  1 report
• EluNIR Ridaforolimus Eluting Coronary Stent System LUN400R33US

  Coronary Drug-Eluting Stent
  1 report

Recent EluNIR Ridaforolimus Eluting Coronary Stent System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL CASE DETAILS WERE RECEIVED AS PART OF THE INVESTIGATION BY MEDINOL'S CLINICAL TRIALS PROJECT MANAGER: CORRECTION TO (B)(6) 2019 EVENT NARRATIVE: INFERIOR WALL MI - STENT THROMBOSIS WAS DEMONSTRATED IN THE RIGHT CORONARY ARTERY AT THE POINT WHERE THERE ARE 2 PREVIOUS STENTS (ELUNIR& ANOTHER BRAND). THE SUBJECT WAS TREATED WITH PTCA BALLOONS WITHOUT A STENT. A GOOD ANGIOGRAPHIC OUTCOME WAS OBTAINED, WITH NORMAL FLOW IN THE ARTERY. FOLLOW-UP BAIM MEDICAL SAFETY ASSESSMENT:STENT THROMBOSIS RESULTING IN TARGET LESION REVASCULARIZATION POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS ANTICIPATED. ADDITIONAL INFORMATION: ON (B)(6) 2019, THIS SUBJECT EXPERIENCED UNSTABLE ANGINA. CATHETERIZATION IN (B)(6) 2019 SHOWED PATENT STENTS IN LCX AND LAD, INSIGNIFICANT STENOSIS IN OSTIAL LAD; DISTAL EDGE DISSECTION WAS DEMONSTRATED IN OSTIAL RCA AT THE END OF THE STENT. PTCA WITH A BALLOON WAS PERFORMED, AND A STENT WAS IMPLANTED IN THE MIDDLE RCA SEGMENT. THIS STENT WAS NOT MEDINOL'S STENT. THIS EVENT WAS ASSESSED BY THE PI AS NOT RELATED TO THE DEVICE BUT TO THE PROCEDURE. HOWEVER THE MM (MEDICAL MONITOR) ASSESSED THIS AS POSSIBLE RELATED TO DEVICE AND PROCEDURE -

  Patient problems: Angina; Chest Pain; Myocardial Infarction; Stenosis; Sweating; Thrombosis; Vascular Dissection

  MAUDE report 9897900 ↗
• MalfunctionMar 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CASE DESCRIPTION RECEIVED FORM THE DISTRIBUTOR ON FEB 27, 2020: AS REPORTED, THE DR JUST USED AN ELUNIR LUN350R33US LOT #LNRUS00307. WHEN THE DR GOT THE ELUNIR TO HIS DESIRED DESTINATION THE STENT CAME OFF THE BALLOON. OCCURED INSIDE PATIENT. THE DEVICE WAS NOT IMPLANTED NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON MAR 15, 2020: THE INTENDED PROCEDURE WAS SFA/ TIBIAL'S THE BALLOON USED WAS A 0.18 SABER USED FOR SFA. SNARING OUT WAS THE INTERVENTION DONE BECAUSE OF THE STENT DISLODGEMENT. NO PATIENT INFORMATION AVAILABLE, SUCH AS AGE, DATE OF BIRTH, WEIGHT, HEIGHT, GENDER, MEDICAL HISTORY. THE TARGET LESION WAS ANTERIOR TIBIAL. NO VESSEL TORTUOSITY. THE LESION WAS CALCIFIED MODERATELY. UNKNOWN PERCENTAGE OF STENOSIS. THE DEVICE WAN NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). UNKNOWN VESSEL ANGULATION. THE DEVICE WAS STORED, PREPPED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). NO DAMAGE NOTED TO THE PACKAGE. NO ANOMALIES NOTED TO THE DEVICE WHEN IT WAS TAKEN OUT OF THE PACKAGING. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. THE DEVICE PREPPED NORMALLY (I.E. MAINTAINED NEGATIVE PRESSURE). UNKNOWN IF THERE WERE ANY ANOMA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9863675 ↗
• InjuryDec 18, 2019Off-Label Use; Failure to Advance; Device Damaged by Another Device; Off-Label Use; Failure to Advance; Device Damaged by Another Device

  INITIAL CASE DETAIL REPORT RECEIVED FORM CORDIS ON NOV 24, 2019 HAVE STATED THE FOLLOWING: AS REPORTED, THE DR WAS PUSHING THE STENT IN THE LEFT PT ARTERY AND THE ELUNIR STENT GOT CAUGHT ON A SMART STENT STRUT AND CAME OFF THE BALLOON. THE DR WAS ABLE TO SMASH THE ELUNIR STENT WITHIN THE OTHER STENT AND THERE WAS NO ISSUE OR INJURY FOR THE PATIENT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9488738 ↗
• InjuryDec 17, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS THE PHYSICIAN WAS PUSHING THE 4.0X15 ELUNIR STENT IN THE LEFT POSTERIOR TIBIAL (PT) ARTERY, THE DEVICE GOT CAUGHT ON A SMART STENT STRUT AND CAME OFF THE BALLOON. THE PHYSICIAN WAS ABLE TO SMASH THE ELUNIR STENT WITHIN THE OTHER STENT AND THERE WAS NO ISSUE OR INJURY FOR THE PATIENT. (B)(4).

  Patient problems: No Code Available

  MAUDE report 9483069 ↗
• 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 ↗
• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ADDITIONAL INFORMATION (DATED DEC. 08, 2019). THE PHYSICIAN KNEW THAT THE STEMI WAS DUE TO IN-STENT THROMBOSIS BASED ON THE EKG FROM THE STEMI'S AND THE FACT THE STENTS WERE ALL SHUT DOWN IN BOTH PATIENTS.

  Patient problems: Thrombosis

  MAUDE report 9458212 ↗
• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL CASE REPORT WAS OBTAINED ON NOV. 17, 2019 AND INCLUDED THE FOLLOWING "DESCRIPTION AS REPORTED": "AS REPORTED BY THE SALES REP, PATIENT CAME IN WITH A STEMI ON (B)(6) DUE TO IN STENT THROMBOSIS. PATIENT WAS ON BRILINTA AND WENT OFF DUE TO FINANCIAL REASONS. AFTER PROCEDURE THE PATIENT WAS PUT ON PLAVIX. IT IS UNKNOWN IF THE PATIENT'S DOSAGE WAS CORRECT FOR PLAVIX OR IF THE PATIENTS BODY DIDN'T RESPOND TO THE MEDICATION AS WELL AS IT WASN'T IN THE PATIENTS SYSTEM LONG ENOUGH AFTER THE PROCEDURE WHICH COULD HAVE CAUSED THE ELUNIR STENTS TO SHUT DOWN. BOSTON SCI SYNERGY STENTS WERE PLACED IN THE MID CIRC AND MID LAD" IN ADDITION, THE INFORMATION DETAILED IN 'PRODUCT INFORMATION' IN THE SAME REPORT INCLUDED FOUR (4) PRODUCTS. THERE HAVE BEEN SEVERAL ATTEMPTS TO GET INFORMATION ABOUT WHICH PRODUCT WITHIN THE REPORTED FOUR (4) WAS INVOLVED, BUT NO ANSWER HAS BEEN RECEIVED ON THIS MATTER. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON DEC 3, 2019 STATED AS FOLLOWS: THE DEVICE STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE PREP AS PER THE IFU 1 STENT IN MID CIRC AND 1 STENT IN MID LAD NONE WERE OVERLAP

  Patient problems: Thrombosis

  MAUDE report 9458205 ↗
• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL CASE REPORT WAS OBTAINED ON NOV. 17, 2019 AND INCLUDED THE FOLLOWING "DESCRIPTION AS REPORTED": "AS REPORTED BY THE SALES REP, PATIENT CAME IN WITH A STEMI ON (B)(6) DUE TO IN STENT THROMBOSIS. PATIENT WAS ON BRILINTA AND WENT OFF DUE TO FINANCIAL REASONS. AFTER PROCEDURE THE PATIENT WAS PUT ON PLAVIX. IT IS UNKNOWN IF THE PATIENT'S DOSAGE WAS CORRECT FOR PLAVIX OR IF THE PATIENTS BODY DIDN'T RESPOND TO THE MEDICATION AS WELL AS IT WASN'T IN THE PATIENTS SYSTEM LONG ENOUGH AFTER THE PROCEDURE WHICH COULD HAVE CAUSED THE ELUNIR STENTS TO SHUT DOWN. BOSTON SCI SYNERGY STENTS WERE PLACED IN THE MID CIRC AND MID LAD." IN ADDITION, THE INFORMATION DETAILED IN 'PRODUCT INFORMATION' IN THE SAME REPORT INCLUDED FOUR (4) PRODUCTS. THERE HAVE BEEN SEVERAL ATTEMPTS TO GET INFORMATION ABOUT WHICH PRODUCT WITHIN THE REPORTED FOUR (4) WAS INVOLVED, BUT NO ANSWER HAS BEEN RECEIVED ON THIS MATTER. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON DEC 3, 2019 STATED AS FOLLOWS: THE DEVICE STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE PREP AS PER THE IFU 1 STENT IN MID CIRC AND 1 STENT IN MID LAD NONE WERE OVERLA

  Patient problems: Thrombosis

  MAUDE report 9458194 ↗
• InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE INITIAL CASE REPORT WAS OBTAINED ON NOV. 17, 2019 AND INCLUDED THE FOLLOWING "DESCRIPTION AS REPORTED": "AS REPORTED BY THE SALES REP, PATIENT CAME IN WITH A STEMI ON (B)(6) 2019 DUE TO IN STENT THROMBOSIS. PATIENT WAS ON BRILINTA AND WENT OFF DUE TO FINANCIAL REASONS. AFTER PROCEDURE THE PATIENT WAS PUT ON PLAVIX. IT IS UNKNOWN IF THE PATIENT'S DOSAGE WAS CORRECT FOR PLAVIX OR IF THE PATIENTS BODY DIDN'T RESPOND TO THE MEDICATION AS WELL AS IT WASN'T IN THE PATIENTS SYSTEM LONG ENOUGH AFTER THE PROCEDURE WHICH COULD HAVE CAUSED THE ELUNIR STENTS TO SHUT DOWN. BOSTON SCI SYNERGY STENTS WERE PLACED IN THE MID CIRC AND MID LAD." IN ADDITION, THE INFORMATION DETAILED IN 'PRODUCT INFORMATION' IN THE SAME REPORT INCLUDED FOUR (4) PRODUCTS. THERE HAVE BEEN SEVERAL ATTEMPTS TO GET INFORMATION ABOUT WHICH PRODUCT WITHIN THE REPORTED FOUR (4) WAS INVOLVED, BUT NO ANSWER HAS BEEN RECEIVED ON THIS MATTER. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON DEC 3, 2019 STATED AS FOLLOWS: THE DEVICE STORED AND HANDLED AS PER THE INSTRUCTION FOR USE (IFU). NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE PREP AS PER THE IFU. 1 STENT IN MID CIRC AND 1 STENT IN MID LAD NONE WERE

  Patient problems: Thrombosis

  MAUDE report 9458164 ↗
• MalfunctionDec 4, 2019Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  INITIAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON (B)(6) 2019 HAVE INDICATED THE PHYSICIAN HAVE ATTEMPTED TO USE THE SYSTEM RECENTLY AND THE SHAFT KINKED DURING INSERTION. THERE WAS NO PATIENT INJURY, AND HE FINISHED THE CASE WITH ANOTHER STENT. FURTHER INFORMATION WAS AVAILABLE IN THE DETAILED COMPLAINT REPORT RECEIVED ON (B)(6) 2019 AS FOLLOWS: "AS REPORTED BY THE SALES REP, PLEASE SEND A NEW 2.75X17 ELUNIR TO (B)(6) MEDICAL CENTER 10019386. SEND OVERNIGHT ATTENTION TO (B)(6)/CATH LAB. THE DR. ATTEMPTED TO USE THIS RECENTLY AND THE SHAFT KINKED DURING INSERTION. " THERE WAS NO PATIENT INJURY, AND HE FINISHED THE CASE WITH ANOTHER STENT."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9410117 ↗
• MalfunctionJul 4, 2019Crack; Failure to Advance; Crack; Failure to Advance

  INITIAL REPORT FROM THE DISTRIBUTER RECEIVED ON (B)(6) 2019 STATED: "BROKEN SHAFT, CALCIFIED, CIRCUMFLEX " AND NOTED THAT THE DEVICE PROBLEM OCCURRED DURING USE. FURTHER INFORMATION WAS RECEIVED ON JUNE 10, 2019 FROM THE DISTRIBUTOR: THE PATIENT WAS (B)(6) YEARS OLD, MALE. THE DAMAGE NOTED WHILE TRYING TO GET ACROSS A SEVERE STENOSIS. THE DEVICE USED IN THE PATIENT. THE SHAFT HAD BENT DURING THE PROCEDURE AND CRACKED OUTSIDE THE PATIENT BODY THE PRODUCT WAS STORED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE. THERE WASN'T ANY DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THERE WAS NO DIFFICULTY REMOVING THE PRODUCTS FROM THE PACKAGE. THERE WASN'T ANY DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. THE DEVICE WAS NOT DAMAGED IN ANY WAY PRIOR TO INSERTION INTO THE PATIENT. THERE WASN'T ANY DIFFICULTY INSERTING THE DEVICE INTO THE PATIENT. THERE WAS DIFFICULTY CROSSING THE LESION. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT BRAND. THERE WASN'T ANY PATIENT INJURY. THE PRODUCT WAS REMOVED IN ONE PIECE FROM THE PATIENT EXCEPT FOR THE MID SHAFT THAT WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8762249 ↗
• MalfunctionJun 6, 2019Device Damaged by Another Device; Device Damaged by Another Device

  ACCORDING TO INITIAL REPORT RECEIVED ON MAY 12, 2019: "RUNTHROUGH WIRE WENT DOWN THE ARTERY. STENT WENT OVER THE WIRE TO THE AFFECTED AREA. STENT WAS DIFFICULT TO PASS THE LESION. STENT HAS A SPRING COIL AT THE TIP OF THE STENT AND WITH THE DIFFICULT LESION, THE COIL GOT WRAPPED AROUND THE WIRE AND DUE TO THIS, THE WIRE AND STENT HAD TO BE REMOVED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8674039 ↗
• MalfunctionMar 11, 2019Fluid/Blood Leak; Inflation Problem; Fluid/Blood Leak; Inflation Problem

  THE INITIAL COMPLAINT RECEIVED FROM THE DISTRIBUTER: "AFTER PRE-DILATION OF THE CIRCUMFLEX ARTERY, THERE WAS AN ATTEMPT TO INFLATE THE BALLOON. THE PHYSICIAN SAW THAT THE BALLOON DID NOT INFLATE AND DID NOT RESPOND PROPERLY TO NOMINAL PRESSURE AND IN PARALLEL THE CONTRAST MATERIAL LEAKED OUT OF THE DISTAL PORTION OF THE SHAFT. THERE WAS NO TEAR VISIBLE IN THE BALLOON ITSELF. IT WAS DECIDED AT THIS STAGE TO INSERT ANOTHER BALLOON AND INFLATE THE STENT. THE STENT WAS SUCCESSFULLY OPENED AND IMPLANTED. NO HARM WAS DONE TO THE PATIENT". ADDITIONAL INFORMATION WAS RECEIVED ON MAR. 4TH, 2019 AND ON MAR. 5TH 2019: THE LESION WAS CALCIFIED AND THERE WASN'T ANY VESSEL TORTUOSITY. GUIDING CATHETER XB3.5 6F CORDIS WAS USED. FILDER ASAHI 0.014 GUIDE WIRE WAS USED. THE SDS WAS WASHED FOR RELEASE OF AIR ACCORDING TO THE IFU. THERE WEREN'T ANY LEAKS OR BUBBLES OBSERVED. NO EXCESSIVE FORCE WAS APPLIED ON THE STENT DELIVERY SYSTEM WHILE INSERTING IT OVER THE GUIDE WIRE. A GUIDELINER OR OTHER GUIDE EXTENSION SYSTEM WAS USED. A BUDDY-WIRE WAS NOT USED, THE BALLOON CATHETER DID NOT KINK WHILE BEING USED. THERE WASN'T ANY RESISTANCE/FRICTION WHILE INSERTING THE BALLOON THROUGH THE GUIDE CATHETER OVER T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8406874 ↗
• InjuryFeb 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE INITIAL REPORT WAS RECEIVED FROM THE DISTRIBUTER ON FEB. 6TH, 2019: "FROM WHAT I UNDERSTAND THE DOCTOR WAS INTENDING THE STENT TO BE DEPLOYED IN A DISTAL LESION AND INSTEAD THE STENT STRIPPED OFF FROM THE BALLOON CATHETER IN THE PROXIMAL PART OF THE VESSEL AT WHICH POINT HAD TO BE DEPLOYED IN THAT LOCATION THE DEVICE WAS PREPPED ACCORDING TO IFU. THERE WAS NO PATIENT INJURY" THE TOTAL IMPLANTED QUANTITY IS 1. ADDITIONAL INFORMATION WAS RECEIVED ON FEB. 13TH, 2019: THE TARGET LESION WAS DISTAL CIRC. THE LESION WASN'T CALCIFIED. THERE WAS LITTLE VESSEL TORTUOSITY. THERE WASN'T ANY VESSEL ANGULATION. THE PRODUCT WAS STORED, HANDLED AND PREPARED ACCORDING TO THE IFU. THERE WASN'T ANY EXCESSIVE FORCE APPLIED ON THE STENT DELIVERY SYSTEM WHILE INSERTING IT OVER THE GUIDE WIRE. THE STENT DIDN'T KINK WHILE BEING USED. THERE WASN'T ANY DIFFICULTY CROSSING THE LESION. THE STENT WASN'T EVER IN AN ACUTE BEND. THERE WASN'T ANY DAMAGE NOTED TO THE PACKAGING OF THE DEVICE, NOR KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE PATIENT WENT HOME THAT SAME DAY. ADDITIONAL INFORMATION WAS RECEIVED ON FEB. 17TH, 2019: THE PROCEDURE WAS SUCCESSFUL. THE WIRE BRAND IS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8377031 ↗

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