NIRxcell CoCr Coronary Stent on RX SystemRecalls & reported problems across all models

We found 17 models of NIRxcell CoCr Coronary Stent on RX System by Medinol Ltd. in the FDA's device registry (GUDID). Together they are named in 24 adverse event reports in the FDA's MAUDE database, received between Nov 23, 2015 and Oct 3, 2018 — classified as 3 deaths, 9 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 NIRxcell CoCr Coronary Stent on RX System problems

NIRxcell CoCr Coronary Stent on RX System models

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

• NIRxcell CoCr Coronary Stent on RX System NXL35033US

  Stent, Coronary
  4 reports
• NIRxcell CoCr Coronary Stent on RX System NXL30017US

  Stent, Coronary
  2 reports
• NIRxcell CoCr Coronary Stent on RX System NXL35017US

  Stent, Coronary
  1 death2 reports
• NIRxcell CoCr Coronary Stent on RX System NXL35020US

  Stent, Coronary
  2 deaths2 reports
• NIRxcell CoCr Coronary Stent on RX System NXL40017US

  Stent, Coronary
  2 reports
• NIRxcell CoCr Coronary Stent on RX System NXL25012US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL25017US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL27517US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL27520US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL27533US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL30012US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL30020US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL30033US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL35012US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL35028US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL40008US

  Stent, Coronary
  1 report
• NIRxcell CoCr Coronary Stent on RX System NXL40012US

  Stent, Coronary
  1 report

Recent NIRxcell CoCr Coronary Stent on RX System adverse event reports

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

• MalfunctionOct 3, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  "THE STENT CAME OFF OF THE COVER AND THIS IS THE SECOND ONE THAT HAS OCCURRED IN 4 MONTHS." ADDITIONAL INFORMATION RECEIVED: FROM CORDIS (SEPTEMBER 10, 2018): VESSEL / LESION CHARACTERISTICS: IT IS UNKNOWN WHETHER THE LESION WAS CALCIFIED. IT IS UNKNOWN WHETHER THERE WAS VESSEL TORTUOSITY. IT IS UNKNOWN WHETHER THERE WAS VESSEL ANGULATION . THE DEVICE WAS NOT USED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. THE DEVICE WAS STORED AND HANDLED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY REMOVING THE STYLET OR ANY OF THE STERILE PACKAGING. COMPONENTS: THE DEVICE WAS PREPPED ACCORDING TO INSTRUCTIONS FOR USE (IFU). ANOMALIES NOTED DURING OR AFTER THE DEVICE WAS PREPPED: WHEN PULLING THE CAP OFF TO PREP THE STENT THE ACTUAL STENT CAME OFF THE BALLOON AND WAS STUCK INSIDE THE CAP. THERE WAS NO UNUSUAL FORCE USED AT ANY TIME DURING REMOVAL OF THE DEVICE. THERE WERE NO KINKS OR OTHER DAMAGES NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. THE DEVICE WAS NOT CLINICALLY USED. THE DEVICE WAS NEVER PUT IN PATIENT. THERE WAS SO PATIENT INJURY. FROM CORDIS (SEPTEMBER 12, 2018): TRACKING NUMBER FOR THE DEVICE WAS RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7929276 ↗
• InjuryJul 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT WAS REPORTED ON (B)(6) 2018 (LATE AFTERNOON AT 16.25) AS POST PROCEDURE EVENT OCCURRED ON (B)(6) 2017 TO A PATIENT, PARTICIPATING IN THE (B)(6) CLINICAL STUDY. THE INDEX PROCEDURE THAT WAS PERFORMED ON (B)(6) 2016 WITH NIRXCELL¿ CORONARY STENT SYSTEM. ON (B)(6) 2017, STENOSIS IN THE MID LAD LESION WAS SHOWN ON ANGIOGRAPHY AT THE CLINICAL STUDY SITE. ADDITIONAL DATA, RECEIVED ON APR 04, 2018: ON (B)(6) 2017, DUE TO (B)(6) STUDY, THE SUBJECT UNDERWENT INDEX PROCEDURE WITH DEPLOYMENT OF NIRXCELL STENT SYSTEM TO THE MIDDLE LAD TARGET DE NOVO, PRE-PROCEDURE TIMI FLOW WAS GRADE 3 WITH 80% STENOSIS, NO CALCIFICATION AND RESIDUAL STENOSIS POST STENT DEPLOYMENT WAS 10% WITH TIMI 3 FLOW. LVEF WAS 50% ON (B)(6) 2016. ON (B)(6) 2017 THE SUBJECT WAS EVALUATED FOR AN ASCENDING AORTIC ANEURYSM REPAIR AND WAS REFERRED FOR CORONARY ANGIOGRAPHY. THE ANGIOGRAPHY SHOWED A MODERATE LESION WITHIN THE MID LAD. 60-70% STENOSIS AT THE SITE OF THE FIRST SEPTAL BRANCH. THE DOWN GOING LAD HAD LUMINAL IRREGULARITY. THE LAD GIVES RISE TO 2 SMALL DIAGONAL BRANCHES THAT HAD LUMINAL IRREGULARITY. FRACTIONAL FLOW RESERVE (FFR) MEASUREMENT OF THE MID LAD SHOWED 0.80 AFTER GIVEN 200 MCG OF ADENOSINE. SU

  Patient problems: Aneurysm; Stenosis

  MAUDE report 7722005 ↗
• DeathMay 24, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). DATE OF INDEX PROCEDURE: (B)(6) 2016. TIME TO EVENT (DAYS): 601 DAYS. THIS REPORT IS FOR SUBJECT (B)(6), AN (B)(6) MALE PARTICIPATING IN THE (B)(4) STUDY. ON (B)(6) 2016, DUE TO STABLE ANGINA (CCSC II), THE SUBJECT UNDERWENT INDEX PROCEDURE WITH DEPLOYMENT OF NIRXCELL STENT SYSTEM TO THE MIDDLE LAD TARGET DE NOVO, PRE-PROCEDURE TIMI FLOW WAS GRADE 3 WITH 75% STENOSIS, NO CALCIFICATION, RESIDUAL STENOSIS POST STENT DEPLOYMENT WAS 0% WITH TIMI 3 FLOW. LVEF WAS 55% ON (B)(6) 2016. ON (B)(6) 2017, THE SUBJECT EXPERIENCED CARDIAC ARREST. THE SUBJECT WAS BROUGHT TO ER BY EMS IN FULL CARDIAC ARREST WITH CPR IN PROGRESS AFTER SUBJECT'S FAMILY REPORTED SUBJECT PASSING OUT AT HOME. HIS VITAL SIGNS WERE 92.8 T, UNLABORED, 74/40. THE SUBJECT WAS INTUBATED, CHEST COMPRESSIONS INITIATED AND ACLS PROTOCOL INITIATED. THE SUBJECT EXPIRED IN THE ER ON (B)(6) 2017 AT 11:17. IN THE INVESTIGATOR'S OPINION, THE EVENT OF CARDIAC ARREST WAS CONSIDERED SEVERE IN INTENSITY, UNRELATED TO THE STUDY DEVICE AND UNRELATED TO THE STUDY PROCEDURE. THE SPONSOR CONSIDERED THE EVENT OF CARDIAC ARREST ANTICIPATED, POSSIBLY RELATED TO THE STUDY DEVICE AND UNRELATED TO THE INDEX PROCEDURE. SPONSOR CO

  Patient problems: Cardiac Arrest; Death; Sudden Cardiac Death

  MAUDE report 7540057 ↗
• DeathMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED, THE PATIENT UNDERWENT INDEX PROCEDURE WITH DEPLOYMENT OF NIRXCELL (3.5X20 US) STENT SYSTEM IN THE MID LAD DUE TO UNSTABLE ANGINA. APPROXIMATELY ONE YEAR LATER, THE SUBJECT HAD OUT-OF-HOSPITAL CARDIAC ARREST. ACCORDING TO THE ER PHYSICIAN, THE SUBJECT WAS INTUBATED AT THE TIME OF PRESENTATION. SUBSEQUENTLY, SHE PULLED HER TUBE OUT. HE RE-INTUBATED HER AFTER SEDATION AND GAVE HER IV AMIODARONE. HER VITAL SIGNS WERE BLOOD PRESSURE 96/44, HEART RATE VENTRICULAR-PACED IN THE 80S, UNDERLYING ATRIAL MECHANISM MAY BE ATRIAL FIBRILLATION. LABORATORY TESTS SHOWED ABG PH OF 7.4I, P02 OF 242, CO2 OF 34, SATURATIONS OF 100%. SODIUM WAS 142, POTASSIUM 3.3, BUN AND CREATININE 15 AND 2.0 RESPECTIVELY. TROPONIN WAS 0.571. CARDIAC CATH SHOWED LAD: OSTIAL 80% STENOSIS AND PROXIMAL 60% STENOSIS. THE PATIENT UNDERWENT A SUCCESSFUL PCI OF OSTIAL AND PROXIMAL/MID LAD WITH BMS NO RESIDUAL STENOSIS. THE PATIENT HAD RECURRENT INTRA-PROCEDURE V-FIB WHICH WAS SUCCESSFULLY DEFIBRILLATED, FINAL AV PACED RHYTHM. AN ECG SHOWED ATRIAL-SENSED VENTRICULAR-PACED RHYTHM WITH PROLONGED AV CONDUCTION, VENTRICULAR RATE 70 8PM, PR INTERVAL 304MS, QRS DURATION 216 MS QT/QTC 536/578 MS. THE NEXT DAY, THE PATIEN

  Patient problems: Myocardial Infarction

  MAUDE report 7504917 ↗
• DeathMay 3, 2018Occlusion Within Device; Occlusion Within Device

  ADDITIONAL INFORMATION RECEIVED: ANGIOGRAM ANALYSIS ((B)(6) 2018):THE CLINICAL EVENTS ARE UNRELATED TO THE INDEX PROCEDURE AND STUDY DEVICE. IFU REVIEW ((B)(6) 2018):NO DEVIATION OF IFU WAS REPORTED. THREE (3) EVENTS HAVE OCCURRED ON THE SAME SETTING: LAD STENOSIS ((B)(6) 2017); MYOCARDIAL INFARCTION ((B)(6) 2017); MULTI-ORGAN FAILURE ((B)(6) 2017). AS PER THE CEC ADJUDICATION MEETING DATED (B)(6) 2018: (THE REVASC FOR THIS SUBJECT IS PENDING (PENDING DATA)). EVENT TERM: MYOCARDIAL INFARCTION MYOCARDIAL INFARCTION (ARC) ADJUDICATED EVENT TERM: SPONTANEOUS MI (TARGET VESSEL); MYOCARDIAL INFARCTION (HISTORIC DEFINITION): NON-Q WAVE MI (TARGET VESSEL); DEVICE RELATEDNESS: POSSIBLY RELATED. EVENT TERM: MULTI ORGAN FAILURE DEATH ADJUDICATED EVENT TERM: DEATH, CARDIAC; DEVICE RELATEDNESS: POSSIBLY RELATED.

  Patient problems: Death

  MAUDE report 7482402 ↗
• MalfunctionApr 4, 2018Device Issue; Device Issue

  THE PHYSICIAN HAD PASSED THE NIRXCELL STENT PAST A PROXIMAL / MID RCA LESION THAT THE XIENCE STENT WOULD NOT PASS. UPON PASSING THE LESION THE PHYSICIAN BEGAN THE INFLATION OF THE NIRXCELL STENT AND QUICKLY NOTICED THAT BLOOD WAS FILLING UP THE ENDOFLATER. THE PHYSICIAN IMMEDIATELY STOPPED AS IT WAS APPARENT THAT THE BALLOON THE STENT WAS CRIMPED TO WAS DEFECTIVE OR SOMETHING AND HE REMOVED THE NIRXCELL. UPON REMOVAL HE NOTICED THAT THE NIRXCELL STENT WAS SCRUNCHED ALL THE WAY TO THE DISTAL END. HE THEN OPENED 3 MORE NIRXCELL STENTS WITH NO ISSUES AND FINISHED THE CASE. NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7395280 ↗
• MalfunctionJun 5, 2017Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  INITIAL INFORMATION: THE TECH HAD DIFFICULTY GETTING THE STYLET OFF THE SYSTEM. ONCE HE TOOK THE STYLET OFF, HE INSPECTED THE SYSTEM AND SAW THAT THE STENT WAS PARTIALLY DISLODGED FROM THE BALLOON. THIS WAS INFORMATION GIVEN BY ANOTHER PARTY. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION ON MAY 18, 2017: NIRXCELL WAS HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE. BOTH THE DOCTOR AND THE TECH TRIED TO REMOVE THE SHIPPING MANDREL STATING THAT THE METAL EYE WAS UNDER THE PLASTIC AND IT WAS VERY DIFFICULT TO REMOVE. THE STENT WAS NOT MANIPULATED AFTER REMOVING THE PROTECTIVE SLEEVE WITH SHIPPING MANDREL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6610446 ↗
• InjuryApr 27, 2017Failure to Advance; Failure to Advance

  (B)(6) MALE PATIENT WHO IS ACTIVE DRUG USER (HEROIN) HAD HIGH RISK BIFURCATION LESION AT MID LAD AND 2ND DIAGONAL BRANCH; ONE 3.0 X 17 NIRXCELL WAS SUCCESSFULLY DEPLOYED AT MID LAD. HOWEVER, PLAQUE SHIFTED DISTALLY CREATING THE NEED FOR A SECOND STENT PLACEMENT. AT THAT TIME, A SECOND NIRXCELL SIZE 3.0 X 12 WAS SELECTED TO BE PLACED DISTAL TO THE 3.0 X 17 BUT WAS UNABLE TO RECROSS THE JUST DEPLOYED 3.0 X17. THE PHYSICIAN PULLED OUT THE 3.0 X 12 NIRXCELL AND WAS ABLE TO SUCCESSFULLY DEPLOY A 3.0 X 12 STENT FROM OTHER COMPANY WHICH DID RECROSS THE JUST DEPLOYED 3.0 X 17 NIRXCELL. PROCEDURE WAS THEN COMPLETED WITH OTHER COMPANY'S STENT SIZE 2.5 X18 DEPLOYED IN THE 2ND DIAGONAL. STAFF NOTED THAT THEY HAD DIFFICULTY KEEPING PATIENT STILL WHICH RESULTED IN PATIENT LOSING HIS IV AND REPEATED ATTEMPTS TO INTRODUCE HEPARIN WERE UNSUCCESSFUL AS A RESULT THEY WERE UNABLE TO GET ACT TO TARGET. THE LOST IV WAS NOTICED AT COMPLETION OF CASE AS A PUDDLE OF HEPARIN SOLUTION WAS FOUND ON THE FLOOR. PER THE RN AND RT IN THE CASE, THIS LIKELY LED TO THE THROMBUS THAT OCCURRED DURING THE PROCEDURE WHILE TRYING TO DELIVER THE 2ND NIRXCELL STENT (3.0 X 12). PATIENT'S BLOOD WAS IN A HYPERCOAGUABLE STATE

  Patient problems: Myocardial Infarction; Stenosis; Thrombus

  MAUDE report 6525274 ↗
• MalfunctionApr 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE STENT CAME OFF THE STENT DELIVERY BALLOON IN THE GUIDE CATHETER AS THE DOCTOR WAS RETRIEVING IT FROM THE OSTIAL RCA BECAUSE IT WOULDN'T CROSS. WHEN HE PULLED THE SDS ALL THE WAY OUT HE NOTICED THE STENT WASN'T ON THE BALLOON. HE THEN USED FLUORO AND DETERMINED THE STENT WAS IN THE GUIDE CATHETER AT WHICH TIME HE HAD TO PULL THE GUIDE AND WIRE OUT OF THE PATIENT. DE NOVO, 85% STENOSIS, NO BIFURCATION, NO PRE EXISTING CLOT. THERE WAS NO PRE DILATION. LESION CALCIFICATION: MEDIUM. VESSEL CALCIFICATION: LOW. VESSEL WAS NOT TORTUOUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION: THE SYSTEM WAS INSPECTED PRIOR TO USE AND APPEARED NORMAL. THE SYSTEM WAS STORED, HANDLED AND PREPPED ACCORDING TO THE IFU. THE GUIDING CATHETER AND STENT DELIVERY SYSTEM WERE NOT REMOVED AS A SINGLE UNIT. THE DELIVERY SYSTEM WAS REMOVED BY RETRACTING IT INTO THE GUIDING CATHETER.

  Patient problems: No Consequences Or Impact To Patient; Stenosis

  MAUDE report 6474625 ↗
• MalfunctionApr 9, 2017Break; Kinked; Improper or Incorrect Procedure or Method; Difficult to Advance; Break; Kinked; Improper or Incorrect Procedure or Method; Difficult to Advance

  REPORTABILITY WAS DECIDED ON MARCH 28, 2017 AFTER RE-REVIEWING THE EVENT FILE. STEMI PATIENT THAT ALSO HAD AN ABDOMINAL AORTIC ANEURYSM WITH MULTIPLE LESIONS IN LAD AND OM1; PHYSICIAN AND STAFF IN THE CASE NOTED EXTREMELY TORTUOUS ANATOMY ESPECIALLY AT THE SITE OF THE UNTREATED LESION, MID OM1; THERE WAS AN EXTREMELY TIGHT TORTUOUS LOOP IN THE OM1 WHERE THE NIRXCELL 2.5 X 12 WAS UNABLE TO TRACK TO DESPITE THE USE OF A GUIDELINER, MULTIPLE PRE DILATIONS, AND DEPLOYMENT OF A 2.5 X 17 IN THE PROXIMAL OM1; PHYSICIAN APPLIED ENOUGH PUSH ON THE SDS OF THE NIRXCELL 2.5 X 12 THAT THE CATHETER KINKED AND EVENTUALLY SNAPPED; THE PATIENT WAS NOT HARMED DURING THE PROCEDURE; ULTIMATELY NO STENTS WERE ABLE TO TRACK TO THIS LESION IN THE MID OM1; THE PHYSICIAN WAS ABLE TO SUCCESSFULLY TREAT A TIGHT LESION IN THE LAD WITH A 3.0 X 17 NIRXCELL AND A DIFFERENT LESION IN THE PROXIMAL OM1 WITH A 2.5 X 17 NIRXCELL. THE DEVICE WAS USED IN ACUTE MI. DE NOVO, STENOSIS 95%, NO BIFURCATION, NO PRE EXISTING CLOT. THERE WAS PREDILATION WITH PRESSURE 12. STENT DILATION PRESSURE WAS 18. THERE WAS POST DILATION WITH PRESSURE 20. TIMI FLOW PRE PROCEDURE WAS 2 AND TIMI FLOW POST PROCEDURE WAS 3. TWO STENTS WERE DE

  Patient problems: Aneurysm; Myocardial Infarction; Stenosis

  MAUDE report 6474624 ↗
• InjuryApr 9, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE NIRXCELL STENT DISLODGED FROM THE DELIVERY SYSTEM WAS REPORTED. NIRXCELL INFLATED TO 6 ATM AND THEN A "WATERMELON SEED" EFFECT WAS NOTICED IN WHICH STENT MOVED TOWARD/INTO AORTA. DURING THE NEXT PICTURE, THE STENT WAS NOT SEEN. ENTIRE SYSTEM (GUIDE CATHETER, GUIDE WIRE, STENT DELIVERY SYSTEM) WAS REMOVED FROM PATIENT. EVENTUALLY STENT WAS FOUND UNDER FLOURO IN PATIENTS SFA. THE DOCTOR WAS ABLE TO INFLATE A DIFFERENT BALLOON IN THE SFA TO CRUSH THE NIRXCELL INTO THE VESSEL WALL, AS STENT WAS NOT ABLE TO BE RETRIEVED/REMOVED. STENT HAD BECOME LODGED BECAUSE PATIENT HAD A CHRONIC TOTAL OCCLUSION IN THE SFA. CTO WAS FIXED DURING VASCULAR SURGEON'S PROCEDURE. THE LESION WAS PROXIMAL RCA NEAR OSTIUM. PATIENT IS CURRENTLY STABLE. THE NIRXCELL STENT SYSTEM APPEARED NORMAL DURING INSPECTION PRIOR TO USE. THE SYSTEM WAS PREPPED ACCORDING TO THE IFU. THE DOCTOR DID NOT NOTICE ANY PROBLEM OF STENT RETENTION ON THE BALLOON. NO EXTENSIVE FORCE WAS USED DURING PROCEDURE. THERE WAS NO INJURY TO PATIENT.

  Patient problems: Vessel Or Plaque, Device Embedded In

  MAUDE report 6474617 ↗
• MalfunctionMar 8, 2017Kinked; Material Deformation; Kinked; Material Deformation

  SYSTEM 3.5X12 DID NOT ADVANCE OVER GUIDEWIRE (INSIDE PATIENT). STRUT POPPED OUT OF STENT (OUTSIDE PATIENT). SYSTEM WAS INSPECTED PRIOR TO USE AND PREPPED ACCORDING TO INSTRUCTIONS FOR USE. NO PROBLEMS WERE NOTED. NO EXCESSIVE FORCE WAS APPLIED DURING PREPARATION OR INSERTION. WHEN THE DOCTOR COULD NOT CROSS THE LESION HE WITHDRAW THE SYSTEM TO EXCHANGE GUIDEWIRE, AND THEN NOTICED THE STRUT POPPING OUT. THERE WERE NO DIFFICULTIES WITHDRAWING THE SYSTEM. THE SYSTEM AND GUIDING CATHETER WERE NOT WITHDRAWN AS A SINGLE UNIT. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6386535 ↗
• InjuryJan 10, 2017Occlusion Within Device; Occlusion Within Device

  ON (B)(6) 2016 EVENT RECEIVED FROM (B)(4) STUDY. INITIAL DESCRIPTION: "PATIENT C/O CP (CHEST PAIN) IN OFFICE ON (B)(6) 2016 & SET FOR HEART CATH ON (B)(6) 2016, INSTENT RESTENOSIS FOUND IN STUDY STENT & RE-STENTED TO RCA". OUTCOME: RECOVERED/RESOLVED. ADDITIONAL INFORMATION ON DEC 20, 2016: THE TARGET VESSEL WAS RCA: CASS (CORONARY ARTERY SURGERY SEGMENT) 3 -DIST RCA. THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2016. THE DOCTOR FOR INDEX PROCEDURE AND FOR RE-STENTING WAS DR. (B)(6). THE PATIENT CAME IN FIRST IN PAIN ON (B)(6) 2016, AND AGAIN ON (B)(6) 2016 TO BOOK THE DATE FOR RE-STENTING PROCEDURE. THERE WAS NO INJURY TO THE PATIENT DURING INDEX PROCEDURE AND IT WAS COMPLETED SUCCESSFULLY. ADDITIONAL INFORMATION ON DECEMBER 22, 2016: MEDTRONIC INTEGRITY STENT WAS USED FOR THE RE-STENTING PROCEDURE ON (B)(6) 2016. THE SITE BECAME AWARE OF THE EVENT ON DECEMBER 12, 2016. THE PATIENT IS GOOD AT THE TIME OF FOLLOW-UP. THE PHYSICIAN WHO PERFORMED THE RESTENOSIS PROCEDURE WAS DR. (B)(6). ADDITIONAL INFORMATION ON DEC 29, 2016: THE REVASCULARIZATION PROCEDURE TOOK PLACE AT THE SAME HOSPITAL, (B)(6) MEDICAL CENTER. DR. (B)(6) IS ONE OF THE DR. (B)(6)'S PARTNERS.

  Patient problems: Chest Pain; Stenosis

  MAUDE report 6236121 ↗
• InjuryJan 4, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  INITIAL INFORMATION: TRIED TO PLACE STENT IN RCA WHEN IT CAME OFF THE SYSTEM. THEY CRUSHED THE STENT WITH A BALLOON AND THEN PLACED AN ABBOTT VISION STENT TO COVER THE CRUSHED STENT. PATIENT IS CURRENTLY IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED DEC 14 2016: DOCTOR WAS TRYING TO DELIVER THE STENT TO THE LESION. STENT WASN'T ABLE TO CROSS LESION AND ENDED UP COMING OFF THE DELIVERY SYSTEM. THEY TRIED TO RETRIEVE WITH SNARE BUT WAS UNABLE TO. SO THEY CRUSHED THE STENT WITH A BALLOON AND THEN PLACED AN ABBOTT VISION OVER THE CRUSHED STENT. THE PHYSICIAN WAS TRAINED WITH THE PROCEDURE. VISUAL INSPECTION WAS PERFORMED PRIOR TO USE, AND THE STENT WAS HANDLED PROPERLY AND USED ACCORDING TO THE IFU. THE DOCTOR DID NOT NOTICE DAMAGE TO THE SYSTEM PRIOR TO USE. THE VESSEL WAS CALCIFIED BUT WAS NOT TORTURES. PRE DILATATION WAS NOT PERFORMED. FOLLOWING THE PROCEDURE THE SYSTEM WAS INSPECTED AND WAS FOUND TO BE UNDAMAGED. THE CONDITION OF THE PATIENT WAS STABLE.

  Patient problems: No Consequences Or Impact To Patient; Vessel Or Plaque, Device Embedded In

  MAUDE report 6220807 ↗
• InjuryJan 4, 2017Device Issue; Device Issue

  DESCRIPTION: I RECEIVED AN EMAIL FROM DR. (B)(6) THAT STATING "WE RECENTLY HAD 2 ACUTE STENT THROMBOSIS WITH MEDINOL. I CALLED (B)(6) TO DISCUSS AS HE IS THE PRIMARY USER OF NIRXCELL AT THIS ACCOUNT. HE SAID HE WAS GOING TO LOOK THE PATIENTS UP NEXT WEEK AND LET ME KNOW THE DETAILS." THIS COMPLAINT WAS INITIALLY RECEIVED AND FILED AS (B)(4) ON (B)(6) 2016. LATE EVENING ON (B)(6) 2016 MEDINOL RECEIVED EMAIL FROM MEDINOL USA CONFIRMING THAT THIS COMPLAINT INVOLVED TWO DIFFERENT PATIENTS. AS A RESULTS MEDINOL OPENS THIS COMPLAINT (B)(4) FOR THE SECOND INCIDENT. ADDITIONAL INFORMATION RECEIVED DEC 20 2016: ON (B)(6) 2016 A FEMALE WITH NON STEMI ANGINA WAS SCHEDULED FOR A HEART CATH WITH DR. (B)(6). IT WAS DISCOVERED SHE HAD A NATIVE CIRCUMFLEX LESION THAT WAS TREATED WITH A 3.0X20 NIRXCELL (NO LOT # AVAILABLE). ON (B)(6) 2016 SHE PRESENTED TO THE ER WITH BACK AND CHEST PAIN AND DR. (B)(6) DISCOVERED A PROXIMAL EDGE STENOSIS OF THE NIRXCELL IN WHICH HE PLACED A XIENCE STENT WHICH OVERLAPPED THE NIRXCELL. DR. (B)(6), DR. (B)(6) AND MYSELF ALL AGREED IT WAS EDGE RESTENOSIS NOT AN ST. COMPLAINT CLASSIFICATION WAS CHANGED FROM STENT THROMBOSIS TO IN-STENT RESTENOSIS.

  Patient problems: Pain; Stenosis

  MAUDE report 6220806 ↗

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