MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271); Ischemia Stroke (4418)

Event Date 01/24/2021

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

Wise b;albarran-rincon r;de lossada juste a;aio ae;klesius a;biundo e;maes e;cordon a;ramos p;garcia-bolao i.Economic evaluation of an ultra-high density mapping system compared to non-ultra-high density mapping systems for radiofrequency catheter ablation procedures in patients with atrial fibrillation.J interv card electrophysiol;year:2021;date:2021/02/07.A retrospective observational micro-costing study was conducted to evaluate the potential economic benefits associated with the use of an uhdms (rhythmia mapping system, boston scientific corporation) for rfa procedures in af patients, compared to conventional nuhdms (non-boston scientific mapping system and catheters).The study was carried out using data from a single center (clinica universidad de navarra) in spain.A cohort of 120 consecutive patients with a diagnosis of either paroxysmal (n=78), persistent af (n=28) or long-standing persistent af (n=14), and 18 years of age or older at the time of index procedure (i.E., first rfa), were included.Patients were included if they had received rfa for the index case either with nuhdms (control group) between 01 june 2015 and 31 december 2015 (n=57) or with uhdms (study group) between 01 june 2017 and 31 december 2017 (n=63).The nuhdms group was an historic cohort of patients that had undergone rfa using non-boston scientific duo-decapolar spiral diagnostic or mapping catheters, while the uhdms group included patients using rhythmia (intellamap orion, boston scientific corporation of 64 poles).For the uhdms group, the intellanav mifi 4-mm irrigated catheter with local impedance was used.For the nuhdms group, standard 4mm irrigated with contact force was used.Ablation settings per protocol were followed, 30- 35w of delivered energy depending on site of ablation.In all index procedures, the sole target was pulmonary vein isolation.In re-do procedures, when there was no clear pulmonary vein reconnection, extrapulmonary substrate was accessed in the left atrium and superior vena cava and was left at the opera's discretion.In both arms, all procedures were done by the same operators.According to the center protocol, patients in both groups were followed up at 3, 6, 12, and 18 months post-index procedure (or before it in the case of arrhythmic recurrence).24-hour holter monitoring was requested in each follow-up.Repeat procedures were decided according to clinical criteria of recurrence established in the international guidelines.In the nuhdms group, 10 patients had persistent af and 7 patients long-standing persistent af, compared to 18 patients with persistent af and 7 patients with long-standing persistent af in the uhdms group.The primary endpoints included the number of repeat ablation procedures and resources used per patient.The secondary endpoint was the number of patients with complications.The study protocol was approved by the center's ethics committee and the regional ethics committee.Patient characteristics, resource use, and outcomes data were collected from the patients' electronic health records.A total of 120 patients were allocated to two groups depending on which mapping system was used in their index case.A total of 57 (48%) patients underwent rfa for af using nuhdms, and 63 (53%) patients using uhdms.Mean participant age was 68 years (+/- sd 9.21) in the nuhdms group and 65 years (+/- sd 13.98) in the uhdms group.43 patients (75%) were male patients in the nuhdms group and 53 (83%) in the uhdms group.Baseline patient characteristics are described in table 1, and there were no statistically significant differences between the two groups.Mean hospital stay for the rfa procedure was one and a half days, regardless of the mapping system used (p=0.46).In total, 20 patients had an arrhythmic recurrence and underwent a repeat ablation, of which only one (belonging to the nuhdms group) required a third ablation.Within this subgroup, 6 patients had initially been treated with the uhdms and 14 with nuhdms, observing a significant decrease in the incidence of repeat rfa following recurrent arrhythmia at 16 months when using the uhdms during the index procedure (p=0.027).An uhdms was used in 93% and 89% of repeat procedures in the nuhdms and uhdms index case groups, respectively.There was no difference in baseline characteristics between patients who had a repeat procedure and patients who only had the index procedure.Major complications during the index procedure, which include cardiac tamponade (2), pericardial effusion without need to be drained (2), and stroke (1), occurred in 3 and 2 patients in the nuhdms and uhdms groups, respectively, with no statistically significant difference (p=0.57).In the last decade, research has shown that recurrences of af after the index af ablation procedures may lead to repeat ablation in a considerable number of patients.Recent data show a repeat pv isolation procedure rate of 15% and 40% depending on the duration of the follow-up period and patient characteristics.An important observation in the present study is that the number of repeat rfas following recurrent arrhythmia at 16 months follow-up was lower in the uhdms group than in the nuhdms group (9% vs.25%, respectively).In summary, patients undergoing rfa with an uhdms for af had a 61% reduction in relative risk of having a repeat ablation for recurrent arrhythmia.Af ablation is an invasive procedure that entails risks, most of which are present during the acute procedural period.In this study, there were no statistically significant differences in major complications between the two study groups (p=0.57).The finding suggests that the choice of mapping system does not have an impact on patients' complications.This is a retrospective observational study including 120 patients from a single center, with 63 patients in the uhdms and 57 in the nuhdms group with a follow-up period of 16 months.These design factors limited the capacity to analyze significantly different patient characteristics and costs of repeat procedures.First, the study is not a randomized clinical trial.Given that the objective is to investigate differences in resource use comparing the standard of care to a more advanced technology, the design was deemed adequate.The study was initiated without propensity matching, but patients included in the two respective study arms showed no significant difference in patient characteristics.Additionally, the economic evaluation is limited to inpatient resource use only, excluding outpatient visits due to data availability.This is a first costing study comparing the new generation uhdms with the commonly used nuhdms, and despite the limitations mentioned, improves the understanding of the impact of the choice of mapping system for rfa has on resource consumption.One limitation to point out is that it is a single center and retrospective trial in a relatively small patient cohort.Therefore, this result could be more impactful with a multicentric registry comparing clinical and economic outcomes.In conclusion, this study suggests that patients undergoing rfa with an uhdms for af had a 61% reduction in relative risk of having a repeat ablation for recurrent arrhythmia.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED ABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; 302 parkway, global park ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12415874
• MDR Text Key: 269603219
• Report Number: 2134265-2021-11184
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
• Patient Outcome(s): Required Intervention