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

Model Number	9-ASD-030
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Premature Separation (4045)
Health Effect - Clinical Codes	Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2022
Type of Reportable Event	Malfunction
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 a 30 mm amplatzer septal occluder was chosen for procedure using an amplatzer torqvue delivery system on (b)(6) 2022.There were no issues during device preparation.During procedure, the device presented with a bulging shape and when the user attempted to remove the device, the device disconnected from the cable, embolizing into the patient's left atrium.The device did not occlude the patient's blood flow.The patient immediately became unstable.The patient went into cardiac arrest while waiting to transfer to cardiac surgery.Defibrillation efforts were made and were unsuccessful and the patient passed away.No additional information was provided.
Additional Manufacturer Narrative
An event of device deformity during deployment was reported.A returned device assessment could not be performed as the device was not returned for analysis.One image was received from the field which appeared to show an occluder detached from the delivery cable with a deformation.Based on the information received, the cause of the reported deformation could not be conclusively determined, but may have been due to the larger sized sheath being used to deliver the occluder.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, a 12f delivery system was used in the procedure.Please note, per the amplatzer septal occluder instructions for use: the recommended size delivery system for use with a 30 mm amplatzer septal occluder is a 10f.
Event or Problem Description
This event is being reported for bulging shape and embolization of the 30 mm amplatzer septal occluder it was reported a 30 mm amplatzer septal occluder was chosen for procedure using an amplatzer torqvue delivery system on (b)(6) 2022.There were no issues during device preparation.During procedure, the device presented with a bulging shape and when the user attempted to remove the device, the device disconnected from the cable, embolizing into the patient's left atrium.The device did not occlude the patient's blood flow.The patient immediately became unstable.The patient went into cardiac arrest while waiting to transfer to cardiac surgery.Defibrillation efforts were made and were unsuccessful and the patient passed away.Related manufacturing reference number 2135147-2022-00526-00 (death, cardiac arrest).

• 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): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 14333923
• Report Number: 2135147-2022-00252
• Device Sequence Number: 17464037
• Product Code: MLV
• UDI-Device Identifier: 05415067019332
• UDI-Public: 05415067019332
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/19/2022

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 Expiration Date: 08/31/2026
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 8135779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2022
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 07/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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 TORQVUE DS : 9-ITV12F45/80, 7929270
• Outcome Attributed to Adverse Event: Death
• Patient Age: 45 YR
• Patient Sex: Female