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

Model Number 9-PFO-025

Device Problem Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 07/28/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2021, a 25 mm amplatzer patent foramen ovale (pfo) occluder was chosen for procedure.It was deployed normal sterile fashion and interrogated with intracardiac echocardiography (ice) and fluoroscopy.The device passed the push-pull test and was released from delivery cable.Immediately after release, the device's right atrial disc appeared to migrate into the pfo tunnel.The device was successfully removed with a 25 mm gooseneck snare through a new 10 fr amplatzer torque delivery system.The device was replaced with a 35 mm amplatzer pfo occluder, which was successfully implanted with no further issues.There was no clinically significant delay in procedure and no adverse patient effects.The patient remained hemodynamically stable throughout the procedure.No additional information was provided.

Manufacturer Narrative

An event of device migration was reported.The investigation confirmed, the device met the dimensional specifications when analyzed at abbott.The device history record was reviewed, to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.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: 12372616
• MDR Text Key: 268305819
• Report Number: 2135147-2021-00343
• 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: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 6461434
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention