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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OI

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BOSTON SCIENTIFIC CORPORATION INTELLANAV OI Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Nerve Damage (1979); Cardiac Tamponade (2226); Pericardial Effusion (3271); Ischemia Stroke (4418); Insufficient Information (4580)
Event Date 01/01/2010
Event Type  Injury  
Manufacturer Narrative
Date of event: the event date is unknown.The device is not expected to be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
La greca c, cirasa a, di modica d, sorgato a, simoncelli u, pecora d.Advantages of the integration of ice and 3d electroanatomical mapping and ultrasound-guided femoral venipuncture in catheter ablation of atrial fibrillation.J interv card electrophysiol.2020.Study procedures: cardiac ablation (ca) was performed by two operators under effective anticoagulation with intravenous (iv) heparin, without protamine administration at the end of the procedure.Ca was performed under uninterrupted warfarin or minimally interrupted direct oral anticoagulant (just one dose before the procedure was not administered).Antiarrhythmic drugs were usually withdrawn before scheduled procedure.Patients in atrial fibrillation (af) or with a cha2ds2-vasc score greater than or equal to 1 underwent transesophageal echocardiography within 24 h prior to the ablation.All cas were carried out under general anesthesia.Complete pulmonary veins antrum isolation, combined with cavo-tricuspid (ct) isthmus ablation at operator's discretion, was performed though radiofrequency ablation.The use of intracardiac echocardiography (ice) started in june 2014 after an operator training course and gradually absorbed almost all the procedures, while the use of usvgc started in march 2016 and became immediately a routine in ca procedures.At least 4 femoral vein access points were obtained with or without usgvc, 5 when ice was performed.Two diagnostic catheters were positioned in the coronary sinus and at the his bundle.As for the ice group, a basic study started with the ice catheter placed in the mid right atrium (ra) and the transducer in a neutral position facing the tricuspid valve ("home view").Clockwise rotations allowed sequentially visualization of the mitral valve and interatrial septum, with the left atrium (la) appendage anteriorly and the coronary sinus posteriorly, long-axis view of the upper and lower left pulmonary veins, then the posterior wall of the la and the esophagus, as well as the descending aorta, and the right inferior pulmonary vein (in the posterior and inferior aspect of la), followed by the right superior pulmonary vein (in the anterior and superior aspect of la).La appendage and the ridge between la appendage and left superior pulmonary vein were visualized from right ventricle outflow tract.The ice catheter might be advanced in the coronary sinus to visualize the roof and posterior wall of the la between the left and right pulmonary veins.Double transseptal access to the la was achieved using a standard fluoroscopy approach or with ice integration.Then a multipolar mapping catheter - intellamap orion and the ablation catheter - intella nav open-irrigated ablation catheter, and intella tip mifi open irrigated ablation catheter were placed in the la for electroanatomic mapping.Patients with af at the beginning of the index procedure underwent electrical cardioversion.La mapping was performed in sinus rhythm or during af, if the electrical cardioversion failed.After left atrium reconstruction, radiofrequency pulses were delivered in power control mode (25 and 35 w depending on the different left atrial sites) to produce a circumferential ablation around the proximal part of each pulmonary vein (pv) ostium or around ipsilateral pvs according to patients' anatomy or operators' preference.The lesion around the pvs ostium was created by sequential point-by-point application of radiofrequency energy.Radiofrequency cardiac ablation (rfca) was performed through complete pulmonary veins antrum isolation.For all patients the procedural endpoint was bidirectional conduction block.A 20 minute observation period was used to assess spontaneous conduction recovery.If spontaneous reconnection or adenosine-provoked dormant conduction was elicited, then additional targeted ablation was performed until conduction was abolished.Femoral veins hemostasis after sheath removal was obtained with manual compression or with figure-of-eight suture.Patient population: from january 2010 to january 2020, 374 patients underwent ca of af in our institution.Baseline clinical characteristics of the included patients are listed in table 1.The median age was 60 years.The majority of patients were male (74%) and had a median body mass index (bmi) of 27 kg/m2; 65.5% had paroxysmal af, and 20% had a redo procedure.Ca procedure: the median duration of the procedure was 180 (iqr 150-210) min, the median fluoroscopy time was 19 min (iqr 12-25), and the median radiofrequency time was 1740s (iqr 1394-2209).Transcatheter ablation of the cavo-tricuspid isthmus was performed in the same procedure in 254 patients.The combined use of ice and usgvc was made in 184 patients (49%).Procedures with integration of ice and usgvc required less fluoroscopy time than procedures without them (median time with ice + usgvc: 14 min (interquartile range (iqr 8-21) vs median time without ice + usgvc: 22 min (iqr 17-32), p < 0.001).Radiofrequency time was lower in procedures with integration of ice and usgvc than in procedures with conventional approach (median time with ice + usgvc: 1686 s (iqr 1367-1998) vs median time without ice + usgvc: 1792 s (iqr 1390-2400), p = 0.012).Complications: sixteen patients had major complications (4.3%); among these are as follows: 10 (2.7%) were major vascular complications, 3 (0.8%) were cardiac tamponade or severe pericardial effusion, 1 (0.3%) was stroke, and two (0.5%) were related to phrenic nerve damage.Thirty-seven patients had minor complications (9.9%) that did not require intervention; among these is as follows: 22 (5.6%) had minor vascular complications (mostly localized hematomas).No death, atrio-esophageal fistula, or pneumothorax were reported.There were fewer major complications in the ca with the aid of ice and usgvc than in the conventional approach (1% vs 7%, p = 0.005).Major vascular complications after performing ca with the aid of usgvc were less frequent than after ca without usgvc (1% vs 5%, p = 0.097).On the other hand, ice allowed a non-significant reduction in severe pericardial effusions/cardiac tamponades (2% in procedures performed without the aid of ice vs 0% in procedures performed with the aid of ice, p = 0.114).Univariate analyses showed that ice, usgvc, and hemostasis with a figure-of-eight suture were useful against major complications.However, in the multivariate analyses only the combined of ice + usgvc significantly reduced the risk of major complications (hazard ratio 0.139, p = 0.05).
 
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Brand Name
INTELLANAV OI
Type of Device
INTELLANAV OI
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer Contact
timothy degroot
4100 hamline avenue north
dc a330
saint paul, MN 55112
6515826168
MDR Report Key11373241
MDR Text Key233311927
Report Number2134265-2021-02292
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeIT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2021
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
Date Manufacturer Received02/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
Treatment
INTELLA TIP MIFI OPEN IRRIGATED ABLATION CATHETER; INTELLAMAP ORION HIGH RESOLUTION MAPPING CATHETER
Patient Outcome(s) Required Intervention;
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