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

Catalog Number	9-ASD-014
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2024
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 a 14mm amplatzer septal occluder was selected for implant on (b)(6)2024.The patient had 2 atrial septal defects (asd).The first asd was measured as 14mm and the second defect was 18mm.Sizing was determined with transesophageal echocardiography (tee) and a non-abbott sizing balloon.The patient was in sinus rhythm during the procedure.Tee was used during the procedure.The 14mm occluder was implanted.An 18mm amplatzer septal occluder was selected for implant on the second asd.Upon implant, a large residual shunt was detected, and it was observed that the device migrated.The device was removed from the patient via transcatheter snare and replaced with a new 24mm amplatzer septal occluder.Upon implant, the device migrated due to one of the edges of the devices not taking to the defect because of its small size.It was noted during implant of the 24mm occluder, the device made contact with the 14mm occluder, causing the 14mm occluder to embolize to the descending aorta.The 24mm occluder and the 14mm occluder were both removed from the patient via transcatheter snare.The cause of the embolization and migrations was believed to have been due to the complexity of the two defects.The implant of each device was difficult due to complex anatomy.The patient remained hemodynamically stable throughout the procedure.There were no adverse effects to the patient.The patient status was hospitalization.
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.Information from the field indicated that the first asd was measured as 14mm and the second defect was 18mm.The 14mm occluder was implanted.An 18mm occluder was selected for implant on the second asd.Upon implant, a large residual shunt was detected, and it was observed that the device migrated.Therefore, the device was removed from the patient via transcatheter snare and replaced with a new 24mm occluder.Upon implant, the device migrated due to one of the edges of the devices not taking to the defect because of its small size.It was noted during implant of the 24mm occluder, the device made contact with the 14mm occluder, causing the 14mm occluder to embolize to the descending aorta.Then, the 24mm occluder and the 14mm occluder were both removed from the patient via transcatheter snare.The cause of the embolization and migrations was believed to have been due to the complexity of the two defects.The implant of each device was difficult due to complex anatomy.Based on the available information, the cause of the reported event appears to be related to procedural condition and patient conditions (due to the complexity of the anatomy).There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 19385761
• Report Number: 2135147-2024-02356
• Device Sequence Number: 3981929
• Product Code: MLV
• UDI-Device Identifier: 00811806010113
• UDI-Public: (01)00811806010113(17)271031(10)8756260
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/09/2024

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-014
• Device Lot Number: 8756260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER SEPTAL OCCLUDER, 9-ASD-018, LOT 7856093; AMPLATZER SEPTAL OCCLUDER, 9-ASD-024, LOT 8778943
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown