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

Model Number 9-PFO-025

Device Problem Biocompatibility (2886)

Patient Problems Arrhythmia (1721); Dyspnea (1816); Nausea (1970); Thrombosis/Thrombus (4440)

Event Date 05/01/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Clinical study: patient id: (b)(6).It was reported that on (b)(6) 2021, a 25 mm amplatzer pfo occluder was successfully implanted in a patient with preexisting conditions of tachycardia.Post-implant the patient was noted to have bleeding issues.On (b)(6) 2021, a hematoma was noted under the incision site with increasing pain.Ultrasound was performed and it was noted not to be a pressing issue.The hematoma later self-resolved on (b)(6) 2021.On (b)(6) 2021, an echocardiogram was performed and revealed a small mobile thrombus on the right atrial side of the implanted device.No intervention was performed and the thrombus was noted to have disappeared on (b)(6) 2021.On (b)(6) 2021, the patient had nausea, palpitations, and shortness of breath while driving.The patient presented to the emergency department and was diagnosed with tachycardia.The patient was given ondansetron orally and the symptoms resolved.The patient was discharged without being admitted to the hospital.There is no allegation that the cause of the tachycardia was due to the abbott device or implant procedure.No additional information was reported.

Manufacturer Narrative

An event of thrombus on the device, which self-resolved was reported.A more comprehensive assessment could not be performed, as the device remains implanted.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.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12315655
• MDR Text Key: 266368793
• Report Number: 2135147-2021-00326
• 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
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7820637
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 51 YR