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

Model Number PFO OCCLUDER

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

Patient Problems Bradycardia (1751); Heart Block (4444)

Event Date 11/26/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical information: crd_961-pfo pms japan, patient id: (b)(6).It was reported that on (b)(6) 2021, a 25mm amplatzer pfo occluder was successfully implanted.There were no reported malfunctions or adverse patient effects after the procedure and the patient was discharged on (b)(6) 2021.On (b)(6) 2022, it was confirmed by notification of the implanted monitor that the patient experienced bradycardia.The patient's family reported that the patient had lost consciousness.The patient was diagnosed with complete atrioventricular block and admitted to the hospital.The implantable monitor was removed, and a permanent pacemaker was placed.The patient recovered and was discharged on(b)(6) 2022.

Manufacturer Narrative

An event of bradycardia, loss of consciousness, complete atrioventricular block and permanent pacemaker implantation 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.Information from the field indicated that the patient's medical history included unstable angina, cerebrovascular accident (cva), family history of cerebral infarction (parent or sibling), hypertension, ex-tobacco user and hyperlipidemia.Based on the information received, the cause of the reported incident could not be conclusively determined.Na.

• Brand Name: AMPLATZER 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: 16826396
• MDR Text Key: 314126358
• Report Number: 2135147-2023-01863
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PFO OCCLUDER
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7689298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 50 KG