MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-ASD-MF-025

Device Problem Difficult to Fold, Unfold or Collapse (1254)

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

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on 22 november 2023, a 25mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for implant using an unknown delivery system.During deployment, it was noted that the device was cupping on the right atrial (ra) disc and properly seated against the septum.The patient was reported discharged from the hospital.

Event Description

It was reported that on (b)(6) 2023, a 25mm amplatzer multi-fenestrated septal occluder - cribriform was chosen for an atrial septal defect using a 9f torqvue delivery system delivery system.During deployment, it was noted that the device was cupping on the right atrial (ra) disc and properly seated against the septum.The deformed device was never released from the delivery cable while inside the patient.There was no report of any interaction with cardiac structures during deployment and no report of any angulation/kink noticed with the delivery system.A new 30mm amplatzer multi-fenestrated septal occluder - cribriform.The patient remained hemodynamically stable throughout the procedure.The patient was reported discharged from the hospital.

Manufacturer Narrative

An event of device deformity was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and that the product met all defined manufacturing specifications.The cause of the reported incident could not be conclusively determined.Per the instructions for use, the recommended size delivery system for use with a 25mm amplatzer cribriform occluder is an 8f.

• Brand Name: AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER - CRIBRIFORM
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18337321
• MDR Text Key: 330618498
• Report Number: 2135147-2023-05537
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: 00811806010298
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 8496243
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2022
• 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