MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-25 for AGILIS? INTRODUCER, UNKNOWN manufactured by St. Jude Medical, Costa Rica Ltda.
[186574261]
The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Patient Sequence No: 1, Text Type: N, H10
[186574262]
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.
Patient Sequence No: 1, Text Type: D, B5
[186611449]
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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008452825-2020-00167 |
| MDR Report Key | 9879286 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-03-25 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STEPHANIE O' SULLIVAN |
| Manufacturer Street | 5050 NATHAN LANE NORTH |
| Manufacturer City | PLYMOUTH MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 6517565400 |
| Manufacturer G1 | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Manufacturer Street | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL |
| Manufacturer City | ALAJUELA, COSTA RICA 1897-4050 |
| Manufacturer Country | CS |
| Manufacturer Postal Code | 1897-4050 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AGILIS? INTRODUCER, UNKNOWN |
| Generic Name | INTRODUCER, CATHETER |
| Product Code | DYB |
| Date Received | 2020-03-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, COSTA RICA LTDA |
| Manufacturer Address | PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A. EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL ALAJUELA, COSTA RICA 1897-4050 CS 1897-4050 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-25 |