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

Catalog Number	9-PFO-1818
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, a 18-18mm amplatzer talisman pfo occluder was chosen for implant using a unknown delivery system.During procedure, there was some difficulty due to the patient being small and their septum was very floppy.The device was positioned in patent foramen ovale and transthoracic echocardiogram (tte) was used to evaluate the position of the device.The device was released, but the patient needed more procedures completed.While completing the other procedures the device location had changed and upon review it was seen in left ventricle.There was partial obstruction/blockage of blood flow.Due to patient size, transvenous retrieval procedure was not an option and the device was surgically retrieved.The cause of embolization was unknown.The patient was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of migration or expulsion of device and partial obstruction/blockage of blood flow 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 for the reported migration or expulsion of device (device embolization) could not be determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 19615471
• Report Number: 2135147-2024-03028
• Device Sequence Number: 6140704
• Product Code: MLV
• UDI-Device Identifier: 05415067033307
• UDI-Public: (01)05415067033307(17)241031(10)8221784
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2024
• Device Catalogue Number: 9-PFO-1818
• Device Lot Number: 8221784
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 13 MO
• Patient Sex: Unknown