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 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on 6 november 2023, a 25 mm amplatzer cribriform septal occluder was chosen for implantation utilizing a 8f amplatzer trevisio delivery system.During deployment of the e atrium disc, it appeared convex and bulged.The device was removed and placed in warm saline solution but the deformation did not resolve.A replacement 25 mm amplatzer cribriform septal occluder was used to complete the procedure successfully.Interaction with cardiac structures occurred.There was no angulation or kink in the delivery system.There were no patient consequences and no clinically significant delay.The patient remained hemodynamically stable throughout the procedure and was reported to be recovered and stable.

Manufacturer Narrative

An event of device deformity during deployment was reported.Information from the field indicated that the correct size delivery sheath was used and that there was no angulation or kink in the delivery system.A returned device assessment could not be performed as the device was not returned for analysis.Four images were received from field.Two images appeared to show bulbously deployed distal disc of an occluder device outside patient.One of the four images showed occluder device connected to the delivery cable outside patient.Last image appeared to be taken during imaging.The distal disc appeared bulbously deployed during deployment.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Manufacturer Narrative

An event of device deformity during deployment was reported.The investigation confirmed the device met functional specifications when analyzed at abbott under non-physiological conditions.Two images from field appeared to show bulbously deployed distal disc of an occluder device outside patient.One of the four images showed occluder device connected to the delivery cable outside patient.Last image appeared to be taken during imaging.The distal disc appeared bulbously deployed during deployment.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on (b)(6) 2023, a 25 mm amplatzer cribriform septal occluder was chosen for implantation utilizing a 8f amplatzer trevisio delivery system.During deployment of the e atrium disc, it appeared convex and bulged.The device was removed and placed in warm saline solution but the deformation did not resolve.A replacement 25 mm amplatzer cribriform septal occluder was used to complete the procedure successfully.Interaction with cardiac structures occurred.There was no angulation or kink in the delivery system.There were no patient consequences and no clinically significant delay.The patient remained hemodynamically stable throughout the procedure and was reported to be recovered and stable.

• 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: 18241873
• MDR Text Key: 329462241
• Report Number: 2135147-2023-05276
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010298
• UDI-Public: (01)00811806010298(17)271031(10)8744121
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P000039
• 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,Followup
• Report Date: 05/16/2024

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: 8744121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 01/03/2024; 04/24/2024
• Supplement Dates FDA Received: 01/10/2024; 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2022
• 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
• Treatment: AMPLATZER TREVISIO
• Patient Sex: Female