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

Model Number SEPTAL OCCLUDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Renal Failure (2041); Hemolytic Anemia (2279)

Event Date 05/09/2023

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) 2000, a 24mm amplatzer septal occluder was implanted in a patient.In fall of 2022, the patient had symptoms of anemia and renal function problems.On (b)(6) 2023, the patient was hospitalized relating to hemolysis symptoms, including hematuria.The physician performed a transesophageal echocardiogram (tee) which showed that the occluder had caused erosion from the right disk of the occluder into the aorta.The patient was diagnosed with a right atria to aorta fistula as the cause of the hemolysis.The patient was then transferred to another hospital and the repair of the fistula was performed on (b)(6) 2023 with a 9mm amplatzer septal occluder in the right atrium.The patient status was reported as stable.

Event Description

It was reported that on (b)(6) 2000, a 24mm amplatzer septal occluder was implanted in a patient.In (b)(6) 2022, the patient had symptoms of anemia and renal function problems.On (b)(6) 2023, the patient was hospitalized relating to hemolysis symptoms, including hematuria.The physician performed a transesophageal echocardiogram (tee) which showed that the occluder had caused erosion from the right disk of the occluder into the aorta.The patient was diagnosed with a right atria to aorta fistula as the cause of the hemolysis.The patient was then transferred to another hospital and the repair of the fistula was performed on (b)(6) 2023 with a 9mm amplatzer septal occluder in the right atrium.The patient status was reported as stable.

Manufacturer Narrative

An event of the patient having symptoms of anemia, renal function problems, hemolysis symptoms including hematuria, right atria to aorta fistula as the cause of the hemolysis was reported.It was also reported that a transesophageal echocardiogram (tee) showed the occluder had caused erosion from the right disk of the occluder into the aorta.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 17046774
• MDR Text Key: 316390882
• Report Number: 2135147-2023-02417
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010199
• UDI-Public: 00811806010199
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 67 YR