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

Model Number	9-ASD-022
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
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 22mm amplatzer septal occluder was selected for procedure.It was noted during procedure that the left atrial disc of the occluder was deformed when being deployed.Several attempts were made to partially recapture the occluder and redeploy it, but the deformation persisted.The decision was made to remove and replace the 22mm amplatzer septal occluder with another one of the same size.There were no adverse patient effects reported.
Additional Manufacturer Narrative
An event of device deformity was reported.The device was returned to abbott for investigation and met functional specifications when analyzed under non-physiological conditions.Information from the field indicated that a larger than recommended size delivery sheath was used during the procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all defined manufacturing specifications.There were no other incidents reported for this lot.The cause of the reported incident could not be conclusively determined but may have been caused by the use of a larger than recommended delivery system.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 22 august 2022, a 22mm amplatzer septal occluder was selected for procedure.It was noted during procedure that the left atrial disc of the occluder was deformed when being deployed.Several attempts were made to partially recapture the occluder and redeploy it, but the deformation persisted.The decision was made to remove and replace the 22mm amplatzer septal occluder with another one of the same size.There were no adverse patient effects reported.Subsequent to the previously filed report, additional information was received that a 10f amplatzer trevisio intravascular delivery system had been used at the time the deformed 22mm amplatzer septal occluder was noted.The deformed occluder was never released from the delivery cable while inside the patient.There was no kink or angulation noted in the delivery system.There were only 3 partial recaptures of the deformed occluder made.The cobra deformation of the amplatzer septal occluder was confirmed/visualized while inside the patient via transesophageal echocardiogram and angiogram examination.It was noted that the same 10f amplatzer trevisio intravascular delivery system was used to implant the second 22mm amplatzer septal occluder.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects reported.

• 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: 15420452
• Report Number: 2135147-2022-01203
• Device Sequence Number: 15091744
• Product Code: MLV
• UDI-Device Identifier: 05415067019295
• UDI-Public: 05415067019295
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/03/2022

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: 01/31/2024
• Device Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 6873427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/22/2022
• Supplement Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2019
• 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 Age: 11 YR
• Patient Sex: Female