• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number RONYX27522UX
Device Problem Fracture (1260)
Patient Problems Chest Pain (1776); Death (1802); Fever (1858); Unspecified Infection (1930); Inflammation (1932); Myocardial Infarction (1969); Sepsis (2067); Injury (2348); Pseudoaneurysm (2605)
Event Date 04/01/2018
Event Type  Death  
Manufacturer Narrative
(b)(4). Journal: elsevier. Title: multimodal imaging of post-stenting mycotic coronary pseudoaneurysm complicated by device fracture and myocardial abscess. Reference: doi. Org/10. 1016/j. Jaccas. 2020. 05. 059. If information is provided in the future, a supplemental report will be issued.
Event Description
A patient was admitted with chest pain and elevated cardiac enzymes. A transthoracic echocardiogram (tte) showed mild pericardial effusion with mild impairment of left ventricular ejection fraction (50%) due to anterior wall hypokinesia. Coronary angiography revealed a critical calcified stenosis of the mid left anterior descending artery (lad), which was treated using percutaneous coronary intervention (pci) and implantation of three overlapping resolute onyx rx coronary drug-eluting stents (des). The proximal-mid lad was successfully pre-dilatated using fully expanded 2. 0 mm and 2. 5 mm noncompliant balloons. A 2. 5x 15 mm resolute onyx des (pli-10) was distally implanted followed by a 2. 75 x22 mm resolute onyx (pli-20) delivered in overlap in the proximal segment. Angiographic results were suboptimal with plaque shift being observed, therefore, a third 2. 5x12 mm resolute onyx (pli-30) was distally implanted in overlap. Proximal and distal post-dilatations were performed with a 3. 0-mm and a 2. 75-mm non-complaint balloon, respectively. The next day, the patient presented with fever and cough and 48 hours after pci, the patient developed episodes of shortness of breath and atypical chest pain. C-reactive protein as well troponin i values were high. Antibiotic treatment was started. Diffuse st-segment elevation (pericarditis-like) was detected at ecg, which was performed 72 h after pci. Pericardial effusion enlargement with further left ventricular ejection fraction reduction (45%), in the absence of active valve endocarditis, were documented at a new tte assessment. 96 h after pci, a cardiac magnetic resonance was performed confirming presence of severe nontamponade circumferential pericardial effusion with evidence also of a coronary pseudoaneurysm (cpsa) at the level of a previously treated mid-lad segment, with a possible stent discontinuity (fracture). Blood cultures resulted positive for staphylococcus aureus. Intravenous antibiogram-guided therapy with oxacillin was started. A diagnosis of post stenting mycotic (infected) cpsa was formulated. The patient was judged to be at very high surgical risk and a percutaneous treatment strategy was chosen to prevent the risk of psa expansion. Coronary angiography confirmed the large mid-lad psa, showing fracture of overlapping implanted des. Pci with a three non medtronic stents was performed. The stents were placed proximally and distally with a large overlap area with the previous one, fully excluding the psa, without evidence of leaks. Tte also detected an irregular and hypoechoic area within the left ventricular myocardium. A multi-slice computed tomography scan confirmed the cpsa exclusion associated with an extended inflammatory mass deeply located within the myocardium, making a surgical excision not feasible. Conservative antibiotic treatment was administered, but, despite an initial promising response, the patient died 3 months later due to sepsis. It is noted in the article that development of mycotic coronary aneurysm and pseudoaneurysm could be linked to the presence of an infective endocarditis or could represent a primary infection at the site of an implanted coronary stent.
Manufacturer Narrative
Additional information: it was stated that the sepsis was not directly related to the resolute onyx. However the systemic infection (sepsis and coronary infection) led to the stent fracture which resulted in the pseudoaneurysm. Procedural images in the article provided the basis of the investigation. The images provided confirm the large pseudoaneurysm involving the previously stented segment reported and a gap between the implanted stent is observed suggesting stent elongation or deformation but the occurrence of material breakage identified as a stent fracture cannot be confirmed from the images. Patient weight provided event date provided date of death provided. If information is provided in the future, a supplemental report will be issued.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Manufacturer (Section D)
parkmore business park west
Manufacturer (Section G)
parkmore business park west
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key10676721
MDR Text Key211235280
Report Number9612164-2020-03866
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX27522UX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/14/2020 Patient Sequence Number: 1