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

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.

• 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 Key: 19042637
• MDR Text Key: 339432962
• Report Number: 2135147-2024-01525
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: (01)05415067033314(17)260731(10)9211404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• 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 Number: 9-PFO-2518
• Device Lot Number: 9211404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White