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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM CATHETER, PERCUTANEOUS

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AGA MEDICAL CORPORATION AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 9-ATV08F45/80
Device Problem Biocompatibility (2886)
Patient Problem Atrial Fibrillation (1729)
Event Date 01/28/2020
Event Type  Injury  
Manufacturer Narrative

An event of atrial fibrillation (af) during the procedure in a patient with no known history of af was reported. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.

 
Event Description

Reference manufacturing report number: 2135147-2020-00120. On (b)(6) 2019, a 35mm amplatzer pfo occluder was implanted using an. The patient has a history of stroke, but did not have any known history of atrial fibrillation. During the procedure while crossing the septum, the patient went into atrial fibrillation. The patient was initially schedules for dc cardioversion on (b)(6) 2019, but converted spontaneously to normal sinus rhythm on his own. On (b)(6) 2020, an injectable loop recorder was implanted.

 
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Brand NameAMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
AGA MEDICAL CORPORATION
5050 nathan lane north
plymouth MN 55442
Manufacturer Contact
pamela yip
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key9851072
MDR Text Key184069694
Report Number2135147-2020-00121
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK190581
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9-ATV08F45/80
Device Catalogue Number9-ATV08F45/80
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/05/2021
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 TREATMENT DATA
Date Received: 03/18/2020 Patient Sequence Number: 1
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