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

Catalog Number 9-ASD-026

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)

Patient Problems Angina (1710); Dyspnea (1816); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/08/2023

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 26mm amplatzer septal occluder was implanted successfully utilizing a 10 french amplatzer trevisio delivery system to treat secundum atrial septal defect with deficient aortic rim.The patient also presented with a dilated right heart.Size of the defect was determined to be 24mm via amplatzer sizing balloon measurement.On (b)(6) 2023, the patient presented with angina and dyspnea.The patient had pericardial effusion suspected to be due to device erosion.The device remained in place where implanted.Pericardiocentesis was performed, however the effusion began to progress into cardiac tamponade.The patient was taken to cardiac surgery where the amplatzer septal occluder was explanted and the atrial septal was surgically repaired.The patient was reported to be stable.

Manufacturer Narrative

An event of angina, dyspnea, pericardial effusion suspected to be due to device erosion was reported.A returned device assessment could not be performed as the device was not returned for analysis.Information from field indicated that pericardiocentesis was performed, however the effusion began to progress into cardiac tamponade.The asd occluder was explanted and atrial septal was surgically repaired.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.

• 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: 18426723
• MDR Text Key: 331824002
• Report Number: 2135147-2024-00002
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010205
• UDI-Public: 00811806010205
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 9-ASD-026
• Device Lot Number: 6796570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2019
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female