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

Catalog Number	9-PFO-3525
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, an amplatzer talisman occluder was implanted off-label inside a watchman device to close a peri-device leak around the watchman.Residual shunt around the watchman remained reportedly due to non-approximation of the proximal disc.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Literature attachment: article title "fourth time¿s a charm: complex closure of incomplete left atrial appendage exclusion".
Event or Problem Description
The article, "fourth time¿s a charm: complex closure of incomplete left atrial appendage exclusion", was reviewed.The article presented a case study of a 69-year-old man with a history of atrial fibrillation (af) presented for the management of recurrent ischemic strokes.It was reported that on an unknown date, a 35-25mm amplatzer talisman pfo occluder was chosen for procedure with a 12f non-abbott deflectable sheath to occlude a peri-device leak of a previously implanted 27mm non-abbott device.It was then noticed via computed tomography angiography (cta) there was a residual shunt of the device due to non-approximation of the proximal disc.A decision was made to implant a 25-18mm amplatzer talisman pfo occluder and the patient's left atrial appendage was successfully closed.[the primary and corresponding author was rodney horton, texas cardiac arrhythmia institute, st.David¿s medical center, 3000 n.Ih-35, suite 720,austin, texas 78705, usa, with corresponding e-mail: rodney.Horton@gmail.Com].

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• Common Device Name: 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: 17755916
• Report Number: 2135147-2023-03996
• Device Sequence Number: 6768345
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: 05415067033345
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PFO-3525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 09/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male