MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA AGILIS¿ INTRODUCER, UNKNOWN; INTRODUCER, CATHETER

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

Patient Problems Stroke/CVA (1770); Inflammation (1932); Nerve Damage (1979); 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: 3005334138-2020-00127, 3008452825-2020-00166, 3005334138-2020-00128.The following was published in the ijc heart & vasculature 26 (2020) 100459 in an article titled ¿european multicentre experience of staged hybrid atrial fibrillation ablation for the treatment of persistent and longstanding persistent atrial fibrillation¿ by g.A.Haywood, received 31 august 2019.The management of non-paroxysmal atrial fibrillation (af) remains controversial.We examined the efficacy and safety of the 2 stage hybrid af ablation approach by analysing the largest series of this technique reported so far.Methods: the approach aims to electrically isolate the left atrial posterior wall incorporating the pulmonary veins (¿box-set¿pattern).An initial video-assisted thoracoscopic (vats) epicardial ablation is followed after a minimum of 8 weeks by endocardial radiofrequency catheter ablation.Results: of 175 patients from 4 european cardiothoracic centers, who underwent the surgical (cobra fusion, atricure inc) 1st stage ablation, 166 went on to complete 2nd stage catheter ablation.At median follow up of 18 months post 2nd stage procedure 93/166 (56%) had remained free of af or atrial tachycardia (at) recurrence off antiarrhythmic drugs.110/175 62.9% were in sinus rhythm off all antiarrhythmic drugs at last clinic follow-up (132/175 75.4% including those on antiarrhythmic drugs).18 patients (10.8%) underwent a further re-do ablation (mean of 1.1 ablations per patient) 105/166 (63%) remained free of af/at recurrence off antiarrhythmic drugs following last ablation procedure.Latterly, ilrs have been implanted in patients (n = 56); 60% have remained fully arrhythmia free and 80% have shown af burden < 5% at a median 14 months follow-up [iqr: 13.5 (8¿21.5)].Only 10.9% have reverted to persistent af.5 patients (2.9%) had a perioperative stroke and 4 patients (2.3%) exhibited persistent weakness of the right hemidiaphragm following stage 1 vats epicardial ablation.One patient died following stroke (overall mortality 0.6%).Conclusions: in patients with non-paroxysmal af with unfavourable characteristics for catheter ablation, the staged hybrid approach results in acceptable levels of freedom from recurrent atrial arrhythmia, however, complication rates are higher than with catheter ablation alone.One patient experienced a transient ischemic attack, four patients experienced stroke, one patient experienced a pericardial effusion, two patients experienced pericarditis and three patients experienced phrenic nerve injuries.Concomitant devices: swartz introducer x 2, agilis introducer x 1.

Manufacturer Narrative

The 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 cerebral vascular accident remains unknown.

• Brand Name: AGILIS¿ INTRODUCER, UNKNOWN
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer (Section G): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 1897- 4050; CS 1897-4050
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9879286
• MDR Text Key: 186574261
• Report Number: 3008452825-2020-00167
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K061363
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• 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: 03/31/2020
• 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