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

Model Number	9-ASD-030
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
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 that on (b)(6) 2022, a 30mm amplatzer septal occluder was selected for procedure.It was noted during procedure that the amplatzer septal occluder exhibited a deformation when being deployed.The decision was made to recapture the amplatzer septal occluder.
Additional Manufacturer Narrative
An event of device deformity was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Per the instructions for use, the minimum recommended size delivery system for use with a 30mm septal occluder is an 10fr.A 12fr sheath was used to deliver the device, which could have contributed to the deformed deployment noted, as use of a larger sheath may influence deformations of the device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on 09 august 2022, a 30mm amplatzer septal occluder was selected for procedure.It was noted during procedure that the amplatzer septal occluder exhibited a deformation when being deployed.The decision was made to recapture the amplatzer septal occluder.Subsequent to the previously filed report, additional information was received that, it was confirmed via fluoroscopy emanation that the amplatzer septal occluder exhibited a cobra deformation when being deployed.There was no angulation or kink noted in the delivery system.The delivery system used was a 12f non-abbott delivery sheath, of which the inner diameter is unknown.The original occluder was never released from the delivery cable and did not interact with any cardiac structures during deployment.No replacement device was implanted and the procedure was aborted.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.The patient was stable at the time of report.

• 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: 15341115
• Report Number: 2135147-2022-00979
• Device Sequence Number: 14584946
• Product Code: MLV
• UDI-Device Identifier: 05415067019332
• UDI-Public: 05415067019332
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted 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): 11/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 6658599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2022
• Supplement Date Received by Manufacturer: 11/11/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 11/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2018
• 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
• Patient Sex: Unknown