NIRxcell CoCr Coronary Stent on RX System NXL35017USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107010955), received between Oct 13, 2016 and May 24, 2018 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 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 ↗
• MalfunctionOct 13, 2016Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION ON OCT 20, 2016: THE DELIVERY SYSTEM WAS RETRACTED THROUGH THE GUIDING CATHETER AND WAS REMOVED BY ITSELF NOT WITH THE GUIDING CATHETER. ADDITIONAL INFORMATION ON OCTOBER 31, 2016: RESULTS OF THE DEVICE INVESTIGATION TOGETHER WITH THE CUSTOMER REPORT INDICATE THAT THE RETURNED PRODUCT WAS SUPPLIED MEETING SPECIFICATIONS. NO ANOMALIES WERE DETECTED THAT COULD ELUCIDATE THE CIRCUMSTANCES FOR THE CUSTOMER REPORTED FAILURE TO CROSS AND SUBSEQUENT STENT DISLODGEMENT AFTER REMOVAL OF THE SYSTEM FROM THE PATIENT. IT MAY BE SURMISED THAT THE REPORTED ISSUES ARE NOT RELATED TO MEDINOL MANUFACTURING PROCESSES. DEVICE INVESTIGATION REPORT IS ATTACHED. ADDITIONAL INFORMATION ON NOVEMBER 8, 2016: INSTRUCTIONS FOR USE WAS REVIEWED. THE REVIEW NOTED THAT THE SYSTEM WAS RETRACTED BACK THROUGH THE GUIDING CATHETER AND NOT TOGETHER WITH THE GUIDING CATHETER AS INDICATED IN THE IFU. IN ADDITION NIRXCELL WAS USED IN THE ACUTE MYOCARDIAL INFARCTION WHICH IS NOT INDICATED IN THE INSTRUCTIONS FOR USE. DHR REVIEW REVEALED NO NEW INFORMATION THAT WOULD CHANGE THE INITIAL REPORT. THE REPORT IS ATTACHED. THE FOLLOWING INFORMATION WAS INADVERTENTLY OMITTED FROM THE INITIAL MDR REPORT:DE

  Patient problems: Myocardial Infarction

  MAUDE report 6025458 ↗