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

Model Number 9-PFO-030

Device Problems Use of Device Problem (1670); Patient-Device Incompatibility (2682); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported a 25mm amplatzer pfo occluder was chosen for cryptogenic stroke recurrence/prevention procedure.During the procedure, the user attempted to deploy the device and the device was unintentionally "delivered' into the left atrium to a different defect anterior to the patients patent foramen ovale (pfo).It was at this time another small atrial septal defect (asd) was discovered.Due to this finding, the 25 mm amplatzer pfo occluder was exchanged for a larger, 30 mm amplatzer pfo occluder.The amplatzer pfo occluder was deployed and released from the cable.A bubble test was performed revealing a massive shunt from the devices edge at the posterior side.The 30mm amplatzer pfo occluder was retrieved by snare.The user removed the device and the "dtv" catheter was changed to a 9 fr, and a 35mm amplatzer pfo occluder was chosen for use.The device was deployed.A repeat bubble test was performed and barely detected a shunt at this time.The procedure was concluded successfully.No patient consequences had occurred.The user reported the procedure was a rare case as the patient presented with two defects.The asd was no detected on imaging prior to implant.In the physicians opinion, the issue due to the patients anatomy.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13255709
• MDR Text Key: 286014567
• Report Number: 2135147-2022-00026
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 14 YR
• Patient Sex: Female