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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 Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
Event Date 03/08/2024
Event Type  Injury  
Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
 
Event Description
Clinical information: crd_806 - pfo occluder pas, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 25-18mm amplatzer talisman pfo occluder was chosen for a procedure using a 8f amplatzer trevisio intravascular delivery system.The occluder was implanted without any difficulty.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.About 2 hours after the procedure, patient complained about pain in the chest/epigastric region and vomited the food they just had.The patient felt better after that but there was a decreased heart rate of ~47-50s with systolic blood pressure of 60mm hg.A 0.5mg of atropine was given via intravenous (iv).A 12-lead electrocardiogram (ekg) was performed, which cane back normal.The physician mentioned the cause of this event was related to the procedure.The patient was repotted discharged same day.
 
Manufacturer Narrative
An event of chest pain and vomiting after two hours of procedure and decreased heart rate was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
 
Event Description
Clinical information: crd_806 - pfo occluder pas, patient site id: (b)(6) ((b)(4)).It was reported that on (b)(6) 2024, a 25-18mm amplatzer talisman pfo occluder was chosen for a procedure using a 8f amplatzer trevisio intravascular delivery system.The occluder was implanted without any difficulty.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.About 2 hours after the procedure, patient complained about pain in the chest/epigastric region and vomited the food they just had.The patient felt better after that but there was a decreased heart rate of ~47-50s with systolic blood pressure of 60mm hg.A 0.5mg of atropine was given via intravenous (iv).A 12-lead electrocardiogram (ekg) was performed, which cane back normal.The physician mentioned the cause of this event was related to the procedure.The patient was repotted discharged same day.
 
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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 Key19042637
MDR Text Key339432962
Report Number2135147-2024-01525
Device Sequence Number1
Product Code MLV
UDI-Device Identifier05415067033314
UDI-Public(01)05415067033314(17)260731(10)9211404
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,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/20/2024
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 Number9211404
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received04/04/2024
Supplement Dates Manufacturer Received05/10/2024
Supplement Dates FDA Received05/20/2024
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
Patient Outcome(s) Required Intervention;
Patient Age53 YR
Patient SexMale
Patient EthnicityHispanic
Patient RaceWhite
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