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

Model Number 9-PFO-2518

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Fibrillation (1729)

Event Date 05/01/2023

Event Type  Injury  

Event Description

Clinical information: (b)(4) - pfo occluder pas, patient site id: (b)(6).It was reported that on 01 may 2023, a 25 x 18mm amplatzer talisman patent foramen ovale (pfo) occluder was selected for procedure.It was noted that during procedure, that the patient developed an onset of atrial fibrillation.It was noted that during procedure the pfo was crossed using a non-abbott 6f catheter and an unknown j-tipped guidewire.The unknown guidewire had been advanced into the left superior pulmonary vein.The device was successfully implanted.Post-implant the patient was in asymptomatic fibrillation, but was discharged.On (b)(6) 2023, it was noted via electrocardiogram during an outpatient visit, that the patient still showed atrial fibrillation.The decision was made to administered the patient pradaxa and flecainide.The patient will undergo a cardioversion if a normal sinus rhythm is unable to be achieved.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

N event of atrial fibrillation was reported.A returned device assessment could not be performed as the device remains implanted and 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 root cause of the reported incident could not be conclusively determined.However, it is believed that the atrial fibrillation was caused by the procedure and specifically, the j-tipped guidewire.There is no allegation of malfunction against the abbott device.Arrhythmia is a potential side effect of the procedure per the pfo instructions for use.

Event Description

Clinical information: (b)(6) - pfo occluder pas, patient site id: (b)(6).It was reported that on (b)(6) 2023, a 25 x 18mm amplatzer talisman patent foramen ovale (pfo) occluder was selected for procedure.It was noted that during procedure, that the patient developed an onset of atrial fibrillation.It was noted that during procedure the pfo was crossed using a non-abbott 6f catheter and an unknown j-tipped guidewire.The unknown guidewire had been advanced into the left superior pulmonary vein.The device was successfully implanted.Post-implant the patient was in asymptomatic fibrillation, but was discharged.On (b)(6) 2023, it was noted via electrocardiogram during an outpatient visit, that the patient still showed atrial fibrillation.The decision was made to administered the patient pradaxa and flecainide.The patient will undergo a cardioversion if a normal sinus rhythm is unable to be achieved.Subsequent to the previously filed report, additional information was received that the patient's atrial fibrillation had not resolved and the patient's medication was changed from metoprolol and flecainide to sotolol.The patient's atrial fibrillation was also considered paroxysmal atrial fibrillation.On 19 may 2023, a cardioversion was performed for the patient's atrial fibrillation.There had been no difficulty experienced implanting the 25 x18mm amplatzer talisman patent foramen ovale (pfo) occluder.The patient had remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.There is no allegation of malfunction against the abbott device.However, it is believed that the atrial fibrillation was caused by the procedure and specifically, the j-tipped guidewire.It was noted that on 04 june 2023, the patient temporarily went back into atrial fibrillation.On 04 june 2023, the patient underwent another cardioversion and a normal sinus rhythm was obtained.

• 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: 16996135
• MDR Text Key: 315908242
• Report Number: 2135147-2023-02303
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: 05415067033314
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-2518
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 8647357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/03/2022
• 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
• Treatment: 6F MPA-2 CATHETER; UNKNOWN J-TIPPED GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White