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

Model Number 9-PFO-025

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complete Heart Block (2627)

Event Date 10/30/2019

Event Type  Injury  

Manufacturer Narrative

An event of the off-label use of an amplatzer pfo, heart block, and removal of the device was reported.The results of the investigation are inconclusive since the device 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note per the instructions for use, artus600609-001 revision d "the amplatzer¿ pfo occluder is indicated for percutaneous transcatheter closure of a patent foramen ovale (pfo)." and "the safety and effectiveness of the amplatzer¿ pfo occluder has not been established in patients with age less than 18 years or greater than 60 years.".

Event Description

On (b)(6) 2019, the patient was evaluated for atrial septal defect closure.The physician had initially intended to use a non-abbott gore occluder, but the user elected to forgo that device due to the less than favorable wire position.A 25 mm amplatzer pfo occluder was then selected, for off-label use.The device was successfully positioned, deployed, and released, but immediately following the release the patient developed 3rd degree heart block.The user decided to remove the device.While prepping the snare, the heart rhythm changed to 2nd degree heart block for which medication was administered.Then while attempting to snare the device the patient reverted to normal sinus rhythm.It was then decided to leave the device in place; however, that evening the patient went into 2nd degree heart block.The following morning, the device was successfully snared and the patient reverted back to sinus rhythm.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 9320828
• MDR Text Key: 166526425
• Report Number: 2135147-2019-00375
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/14/2019

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 Model Number: 9-PFO-025
• Device Catalogue Number: 9-PFO-025
• Device Lot Number: 7132340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2019
• 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: 11 MO
• Patient Weight: 8