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

Catalog Number 9-ASD-017

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  

Event Description

It was reported that a 17mm amplatzer septal occluder was selected for implant on (b)(6)2023 using an 8f amplatzer trevisio intravascular delivery system.During implant, the device took on a cobra shape when the left disc was partially deployed.The device was recaptured and another attempt was made to deploy.The device took on a cobra shape again.The device was removed from the patient.Another attempt was made on the preparation table to deploy the device.The device took on a cobra shape again.It was observed that once the device was fully deployed, the left and right discs flattened out and the device resolved back into its original shape.A second attempt was made to redeploy the device in the patient.No abnormalities were observed after deployment and the device was successfully released.There were no interactions with any cardiac structures nor were there any angulations or kinks in the delivery system.There were no clinically significant delays during the procedure.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.

Manufacturer Narrative

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

Manufacturer Narrative

An event of device deformity was reported.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.Information from field indicated that there was no angulation or kinking in the delivery system.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 the product met all specifications.Per the instructions for use, the recommended size delivery system for use with a 17 mm amplatzer septal occluder is an 7f.A 9f sheath was used to deliver the device, which could have contributed to the deformed deployment noted, as use of a larger sheath may influence deformations of the device.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 was reported.Use of the incorrect size delivery system, anatomical interference, and angulation or kink in the delivery system upon deployment are potential causes of the reported event.Information from field indicated that there was no angulation or kinking in the delivery system.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 the product met all specifications.Per the instructions for use, the recommended size delivery system for use with a 17 mm amplatzer septal occluder is an 7f.A 8f sheath was used to deliver the device, which could have contributed to the deformed deployment noted, as use of a larger sheath may influence deformations of the device.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18239890
• MDR Text Key: 330246120
• Report Number: 2135147-2023-05267
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-017
• Device Lot Number: 8801393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2022
• 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
• Patient Age: 73 YR
• Patient Sex: Female