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This complaint is from a literature source.The following literature cite has been reviewed: young wj, vyas s, wragg a, sporton s, rosengarten j, schilling rj, ang r.Right coronary artery compromise following radiofrequency catheter ablation for supraventricular tachycardia: cases reports.Eur heart j case rep.2023 aug 23;7(9):ytad411.Doi: 10.1093/ehjcr/ytad411.Pmid: 37743895; pmcid: pmc10516517.Objective/methods/study data: the article discuses 2 case studies.Case 1 pertains to the case study with use of biosense webster products.A 43-year-old caucasian male attended an elective cardiac electrophysiology (ep) study and ablation.Three years previously, he had undergone ablation at the cs ostium for a right-sided posteroseptal accessory pathway.However, there was evidence of recovery of the preexcitation on electrocardiogram (ecg) and palpitation symptoms.He had a background of bipolar affective disorder (treated with lithium 1.2 g once evening) with no cardiovascular risk factors and no other relevant medical history.Physical examination was unremarkable.The procedure was performed under general anaesthesia as per the patient¿s preference.The ep study identified non-decremental atrioventricular (av) conduction with proximal to distal atrial activation on the cs catheter.Tachycardia was easily inducible, which made it not possible to determine the refractory period of the accessory pathway.The biosense webster carto3 three-dimensional (3d) mapping system was used, and the earliest ventricular signal that was 30 ms ahead of qrs onset was mapped to the tricuspid valve annulus at the mid-septal position.A biosense webster thermocool smarttouch d-curve catheter with contact force sensing and irrigation was used to deliver ablation at this location (figure 2a).Four brief energy applications had no effect on the pathway (figure 2b).However, ablation at the anterior aspect of the cs lip [65 s; average (av) power, 37 w; av temperature, 37 °c; av force, 12 g; maximum impedance, resulted in a loss of pre-excitation and split atrial and ventricular signals (figure 2c).Repeating the ep study confirmed no anterograde or retrograde pathway conduction.Ten minutes after ablation, with the patient still under general anaesthesia, inferior st-segment elevation was observed on surface 12-lead ecg recording, in the absence of haemodynamic compromise and physical examination was unremarkable (figure 3).A diagnostic coronary angiogram was promptly performed after a multi-disciplinary team discussion.This identified a patent left coronary artery system; however, there was a subtotal occlusion of the posterior left ventricular (plv) artery branch and mild proximal disease of the right coronary artery (rca).Therefore, a 2.5 × 28 mm synergy drug-eluting stent was inserted, restoring thrombolysis in myocardial infarction (timi) score 3 flow with resolution of the st elevation on ecg.The patient was discharged the following day on dual anti-platelet therapy (aspirin 75 mg once daily and prasugrel 10 mg once daily), with no further symptoms; however, his ecg did suggest recovery of the ablated accessory pathway.Echocardiography 2 months later identified a left ventricular ejection fraction of 50¿55% with hypokinetic inferior and basal inferoseptal walls.One year later, he remains well with no chest pain or clinical signs of heart failure and continues on prasugrel 10 mg once daily and atorvastatin 20 mg once evening.Despite pre-excitation on his ecg, he has not had any recurrence of symptoms due to svt suggesting the pathway has been modified.He is therefore being managed conservatively and followed up regularly in the clinic.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch d-curve catheter other biosense webster devices that were also used in this study: carto 3 system non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with unidentified smarttouch ablation catheter: qty 1 inferior st-segment elevation (electrocardiogram st segment elevation) subtotal occlusion of the posterior left ventricular artery branch and mild proximal disease of the right coronary artery (arterial spasm) treated with drug-eluting stent (surgical intervention).
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This complaint is from a literature source.The following literature cite has been reviewed: young wj, vyas s, wragg a, sporton s, rosengarten j, schilling rj, ang r.Right coronary artery compromise following radiofrequency catheter ablation for supraventricular tachycardia: cases reports.Eur heart j case rep.2023 aug 23;7(9):ytad411.Doi: 10.1093/ehjcr/ytad411.Pmid: 37743895; pmcid: pmc10516517.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc, or its employees that the report constitutes an admission that the product, biosense webster inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer¿s reference number: (b)(4).
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