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

Catalog Number	9-ASD-015
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, the patient underwent a mitraclip procedure and the transseptal puncture (tsp) had a biodirectional shunt.The tsp was posterior and mid; the dimensions were 13mm x 10mm and was measured via transesophageal echocardiogram (tee).Therefore, a 15mm amplatzer septal occluder was implanted into the tsp with no reported complications.Stability check was performed and no leak was observed around the lobe of the occluder.On (b)(6) 2024, the septal occluder had dislodged completely from the tsp and ended up in the left atrium.The dislodged occluder did not cause any blockage of blood flow and was percutaneously removed from the patient.The patient was asymptomatic.The physician alleged that the cause of dislodgement was due to not sizing correctly.A new, larger sized amplatzer septal occluder was successfully implanted.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device embolization) was reported.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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the reported device embolization appears to be related to procedural condition (not sizing correctly).The reported surgical intervention was a resulted of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: 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: 21021690
• Report Number: 2135147-2024-06587
• Device Sequence Number: 19851328
• Product Code: MLV
• UDI-Device Identifier: 00811806010120
• UDI-Public: (01)00811806010120(17)271031(10)8765036
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 8765036
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Male