NIRxcell CoCr Coronary Stent on RX System NXL30017USRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290107010887), received between Jan 10, 2017 and Jul 26, 2018 — classified as 2 injuries.

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.

• 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 ↗
• 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 ↗