SWARTZ? INTRODUCER, UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2020-03-25 for SWARTZ? INTRODUCER, UNKNOWN manufactured by St. Jude Medical.

Event Text Entries

[186596514] 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


[186596515] Related manufacturing ref: 3008452825-2020-00166, 3005334138-2020-00128, 3008452825-2020-00167. 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. The patient experienced a stroke which resulted in death. Swartz introducer x 1, agilis introducer x 2.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3005334138-2020-00127
MDR Report Key9879214
Report SourceFOREIGN,LITERATURE
Date Received2020-03-25
Date of Report2020-03-25
Date Mfgr Received2020-03-17
Date Added to Maude2020-03-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal Code55442
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWARTZ? INTRODUCER, UNKNOWN
Generic NameTRANSSEPTAL CATHETER INTRODUCER
Product CodeDYB
Date Received2020-03-25
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL
Manufacturer Address5050 NATHAN LANE NORTH PLYMOUTH MN 55442 US 55442


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-25

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