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

Model Number SEPTAL OCCLUDER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemolytic Anemia (2279)

Event Date 05/08/2023

Event Type  Injury  

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 (b)(6) 2023, a 14mm and 28mm amplatzer septal occluders were implanted in a patient using non-abbott delivery systems.Implant positioning was confirmed by fluoroscopy and echocardiography.It was then reported 48hrs later, the patient began experiencing hemolysis.A decision was made to explant the devices on (b)(6) 2023, and surgically close the defect.The patient status was reported as stable.

Manufacturer Narrative

An event of hemolysis after 48 hours of implant was reported.Gross morphological examination of occluder device revealed the thread on the proximal disc was damaged and unraveled.The patch on proximal disc was partially out of place.The knot was present on the sewing thread on the proximal disc and the thread was cut/torn near the knot.The damage noted to the device is consistent with damage during use.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.The cause of the reported event could not be conclusively determined.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: 17036127
• MDR Text Key: 316291382
• Report Number: 2135147-2023-02386
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: 00811806010212
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 8011969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2021
• 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; Hospitalization