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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

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ABBOTT MEDICAL AMPLATZER TALISMAN PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER Back to Search Results
Catalog Number 9-PFO-2518
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Atrial Fibrillation (1729)
Event Date 03/13/2024
Event Type  Injury  
Manufacturer Narrative
An event of atrial fibrillation was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
 
Event Description
Clinical information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2024, a 25-18mm amplatzer talisman pfo occluder was chosen for procedure using a 10f amplatzer trevisio intravascular delivery system.During procedure, the activated clotting levels were 277 seconds, and 9000 units of heparin was administered.The device was implanted successfully.There was no delay in the procedure.One minute after the deployment, an atrial fibrillation was noted with rapid ventricular response.Amiodarone was given via intravenous and patient was converted back to normal sinus rhythm.The patient was reported discharged in stable condition.
 
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Brand Name
AMPLATZER TALISMAN PFO OCCLUDER
Type of Device
TRANSCATHETER SEPTAL OCCLUDER
Manufacturer (Section D)
ABBOTT MEDICAL
5050 nathan lane n
plymouth MN 55442
Manufacturer (Section G)
ABBOTT MEDICAL REG# 2135147
5050 nathan ln n
plymouth MN 55442
Manufacturer Contact
karen krouse
5050 nathan lane n
plymouth, MN 55442
6517565400
MDR Report Key19055490
MDR Text Key339554941
Report Number2135147-2024-01576
Device Sequence Number1
Product Code MLV
UDI-Device Identifier05415067033314
UDI-Public(01)05415067033314(17)260731(10)9211408
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P120021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study
Reporter Occupation Physician
Type of Report Initial
Report Date 04/05/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number9-PFO-2518
Device Lot Number9211408
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/05/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/25/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV10F45/80
Patient Outcome(s) Required Intervention;
Patient Age35 YR
Patient SexMale
Patient EthnicityNon Hispanic
Patient RaceWhite
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