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

Model Number 9-PFO-025

Device Problems Human-Device Interface Problem (2949); No Apparent Adverse Event (3189)

Patient Problem Abscess (1690)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

On (b)(6) 2018 a 25mm amplatzer pfo occluder was implanted.Patient has a history of migraine headaches, stroke, hypertension, diabetes mellitus, hypercholesteremia, history of tobacco use.It was reported by the patient's mother that the patient had a surgery to remove the device due to pus pocket.The patient was admitted to the hospital with right chest wall abscess which was incised and drained on (b)(6) 2020.The patient was discharged on (b)(6) 2020.

Manufacturer Narrative

Additional information indicated that the device was not explanted from the patient.The surgical intervention to remove the chest abscess was due to a bug bite and was not associated to the abbott device implanted.

Event Description

On (b)(6) 2018 a 25mm amplatzer pfo occluder was implanted.Patient has a history of migraine headaches, stroke, hypertension, diabetes mellitus, hypercholestermia, history of tobacco use.It was reported by the patient's mother that the patient had a surgery due to pus pocket.The patient was admitted to the hospital with right chest wall abscess which was incized and drained on (b)(6) 2020.The abscess began as a small bug bite, per the surgical notes of the abscess drainage.The abscess was not due to the amplatzer device.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10997455
• MDR Text Key: 221231506
• Report Number: 2135147-2020-00528
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011288
• UDI-Public: 00811806011288
• Combination Product (y/n): N
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6564527
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2020
• Initial Date FDA Received: 12/13/2020
• Supplement Dates Manufacturer Received: 12/21/2020
• Supplement Dates FDA Received: 12/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR