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

Model Number 9-PFO-025

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

Patient Problems Stroke/CVA (1770); Endocarditis (1834)

Event Date 02/18/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2018, a 25mm amplatzer pfo occluder was implanted.On (b)(6) 2022, the patient presented with an acute left middle cerebral artery (mca) ischemic stroke and endocarditis.A transesophageal echocardiogram revealed a large vegetation attached to the left atrial disc of the device.The blood cultures were positive for (b)(6) bacteremia.No additional information was provided.

Manufacturer Narrative

An event of acute left middle cerebral artery ischemic stroke, endocarditis and death were reported.A returned device assessment could not be performed as the device remained 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.No indication of a lot related issue was found.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

Subsequent to the initially filed report, additional information was received that the patient died on (b)(6) 2022.The cause of death was due to complications from the stroke that occurred on (b)(6) 2022.Supportive care had been provided to treat the patient's stroke.The patient's endocarditis was being treated with iv antibiotics, and the endocarditis was on the device.The patient's blood cultures on (b)(6) 2022 were positive for mssa.Patient had a history of hypertension, hyperlipidemia, antiphospholipid antibody syndrome.The patient had a history of a previous cerebrovascular accident (cva) which occurred prior to 2018.The physician did not classify this death as being related to the performance of the implanted device.

• 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: 13853429
• MDR Text Key: 287682279
• Report Number: 2135147-2022-00088
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6350538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 87 KG