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

Model Number	9-ASD-020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2022, a 20mm amplatzer septal occluder was implanted without difficulty, and the procedure went well.After the procedure when the patient woke up, they complained of chest pain.Acetaminophen was given for pain.On (b)(6) 2022, an echocardiogram was performed and a small pericardial effusion was observed.On (b)(6) 2022, an echocardiogram showed that the effusion was reducing, and the implant was well in place.On (b)(6) 2022, the physician suggested that pain could have vertebral origin, and an echocardiogram showed that the small pericardial effusion had decreased but was still present.On (b)(6) 2022, there was no evolution on echocardiogram.On (b)(6) 2022, the patient was discharged home.The event required prolonged hospitalization.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of chest pain and pericardial effusion 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.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13988785
• Report Number: 2135147-2022-00114
• Device Sequence Number: 20186821
• Product Code: MLV
• UDI-Device Identifier: 05415067019288
• UDI-Public: 05415067019288
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2022

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 Expiration Date: 02/28/2025
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 7432157
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 04/02/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TORQVUE DELIVERY SYSTEM, 9-ITV09F45/80
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown