MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING

Catalog Number RONYX25012UX

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 was distally implanted followed by a 2.75 x22 mm resolute onyx delivered in overlap in the proximal segment.Angiographic results were suboptimal with plaque shift being observed, therefore, a third 2.5x12 mm resolute onyx 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.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 10676727
• MDR Text Key: 211235105
• Report Number: 9612164-2020-03867
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• 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 Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RONYX25012UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 92