NIRxcell CoCr Coronary Stent on RX System NXL35020USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107010962), received between May 3, 2018 and May 10, 2018 — classified as 2 deaths.

The most frequently reported specific device problem is “Occlusion Within Device” (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.

• 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 ↗