MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. ARRAY CATHETER; CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY

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

Patient Problems Hematoma (1884); Transient Ischemic Attack (2109); Cardiac Perforation (2513)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

Related manufacturing ref: 3005334138-2019-00655, 2030404-2019-00113.The following was published in the balkan medical journal 36.6: 324-330 in an article titled ¿effect of echocardiographic epicardial adipose tissue thickness on success rates of premature ventricular contraction ablation", by selcuk kanat, november 2019.Idiopathic premature ventricular contractions are frequently detected ventricular arrhythmias, and radiofrequency ablation is an effectively treatment for improving symptoms and eliminating premature ventricular contractions.Studies have reported a relationship between an elevated epicardial adipose tissue thickness and myocardial structural pathologies.However, the association between epicardial adipose tissue thickness and success rates of premature ventricular contraction ablation has not yet been investigated.Aims: to assess the relationship between epicardial adipose tissue thickness and success rates of premature ventricular contraction ablation.Study design: retrospective case-control study.Methods: this study enrolled a total of 106 consecutive patients who have had a high premature ventricular contraction burden of >10,000/24-h assessed using ambulatory holter monitorization and underwent catheter ablation.A frequency of premature ventricular contractions of more than 10,000/day was defined as frequent premature ventricular contraction.Epicardial adipose tissue thickness was measured using 2d transthoracic echocardiography.A successful ablation was defined as >80% decrease in pre-procedural premature ventricular contraction attacks with the same morphology during 24-h holter monitorization after a 1-month follow-up visit from an ablation procedure.Results: successful premature ventricular contraction ablation was achieved in 87 (82.1%) patients.Epicardial adipose tissue thickness was significantly higher in patients with unsuccessful ablation (p<0.001).Procedure time, total fluoroscopy time, and radiofrequency ablation time were statistically higher in the unsuccessful group (p<0.001).Stepwise multivariate logistic regression analysis showed that epicardial adipose tissue thickness and pseudo-delta wave time were independently associated with procedural success (both p values <0.001).In the receiver-operating curve analysis, epicardial adipose tissue thickness was found to be an important predictor for procedural success (area under the receiver-operating characteristic curve= 0.85, p=0.001), with a cutoff value of 7.7 mm, a sensitivity of 92%, and a specificity of 68%.Conclusion: epicardial adipose tissue thickness is higher in patients with premature ventricular contraction ablation failure, which may be indicative of procedural success.Procedure-related complications occurred in six patients as follows: cardiac tamponade in two patients, one transient ischemic attack, and three hematomas.The effusion was self-limiting and managed conservatively in patients with successful ablation.In the other patient, the pericardial effusion and the consequent tamponade were timely managed by pericardiocentesis.Transient ischemic attack, was managed conservatively, and the clinical picture was self-limiting with complete recovery.

Manufacturer Narrative

Results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported cardiac perforation, tia, and hematoma remain unknown.

• Brand Name: ARRAY CATHETER
• Type of Device: CATHETER,INTRACARDIAC MAPPING,HIGH-DENSITY ARRAY
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9387763
• MDR Text Key: 168466665
• Report Number: 2182269-2019-00244
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K983456
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other