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

Catalog Number	9-PFO-035
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Enzyme Elevation (1838); Thrombosis/Thrombus (4440)
Date of Event	01/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2020, a 35mm amplatzer pfo occluder was successfully implanted.The patient was prescribed aspirin pre-procedure and continued taking post-procedure.No anticoagulant agent was prescribed but antiplatelet medications were.On (b)(6) 2020, while the patient was still in the hospital, the patients d-dimer values were increasing so a ct was performed.On (b)(6) 2021, a deep vein thrombosis (dvt) was diagnosed by interpretation.Lixiana/edoxaban and aspirin were continued until (b)(6) 2021.On (b)(6) 2021, tee was performed and noted that shunting had improved significantly, but some was still present.The patient was reportedly discharged from the hospital on 23 (b)(6) 2021.It is speculated that the cause of the the dvt was due to prolonged time in their hospital bed.There is no allegation against the abbott device or implant procedure.On (b)(6) 2021, a tte was performed and showed that there was no shunting.
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 deep vein thrombosis and residual shunt 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 cause of the reported incident could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as the patient required medication after the observation of the thrombus.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2020, a 35mm amplatzer pfo occluder was successfully implanted.The patient was prescribed aspirin pre-procedure and continued taking post-procedure.No anticoagulant agent was prescribed but antiplatelet medications were.On (b)(6) 2020, while the patient was still in the hospital, the patients d-dimer values were increasing so a ct was performed.On (b)(6) 2021, a deep vein thrombosis (dvt) was diagnosed by interpretation.Lixiana/edoxaban and aspirin were continued until (b)(6) 2021.On (b)(6) 2021, tee was performed and noted that shunting had improved significantly, but some was still present.The patient was reportedly discharged from the hospital on (b)(6) 2021.It is speculated that the cause of the the dvt was due to prolonged time in their hospital bed.There is no allegation against the abbott device or implant procedure.On (b)(6) 2021, a tte was performed and showed that there was no shunting.

• Brand Name: AMPLATZER 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: 19213871
• Report Number: 2135147-2024-01907
• Device Sequence Number: 8194568
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: (01)00811806011301(17)240930(10)7221955
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P120021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 09/30/2024
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 7221955
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Weight: 66 KG