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

Catalog Number	9-ASD-020
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
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, a 20mm amplatzer septal occluder was implanted using a 10f amplatzer trevisio delivery system.The defect measured 16 x 19mm on 3d tee and 20mm on balloon sizing using a 24mm amplatzer sizing balloon.The device was prepared per ifu and released following a satisfactory stability test.The aortic rim was less than 5mm, but the stability test showed the device was holding firmly in place.Fluoroscopy and transesophageal echocardiogram (tee) were utilized during procedure.No rhythms changes or leak was detected during the implant procedure; no difficulty implanting was reported.On (b)(6) 2024, transthoracic echocardiogram (tte) was performed and showed that the device had moved.It was still attached to some part of the septum, but was detached from the aortic rim.A few attempts to snare the device using a 30mm ensnare was made, however it was unsuccessful and the device embolized to the left ventricle.It is unknown if the device was causing partial blockage in the left ventricle.The physician managed to percutaneously snare the device in the left ventricle and retrieved the occluder from the patient.However, some damage was done to the mitral valve, causing moderate mitral regurgitation.The patient will undergo a mitral valve repair procedure and the asd will be closed surgically.The patient was reported to be stable and recovering but still hospitalized until the surgery.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device migration was reported.A returned device assessment could not be performed as the device was not returned for analysis.Possible causes for device migration or embolization include device over-sizing, device under-sizing or positioning issue due to patient anatomy.It was indicated that there were no rhythms changes or leak was detected during the implant procedure; no difficulty implanting was reported.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 event could not conclusively be 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
• 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: 20152880
• Report Number: 2135147-2024-04364
• Device Sequence Number: 4263302
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: (01)00811806010175(17)280731(10)9202339
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 09/25/2024

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-020
• Device Lot Number: 9202339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/21/2023
• 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: 58 YR
• Patient Sex: Female