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

Model Number	9-ASD-013
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	04/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, a 13 mm amplatzer septal occluder was chosen for procedure on (b)(6)2022.During the procedure, prior to release of the occluder, the occluder presented with a cobra shaped deformation after being re-sheathed two times.The device was removed and both the 13mm amplatzer septal occluder and the 9f amplatzer treviso intravascular delivery system were exchanged with a new 13 mm amplatzer septal occluder and new delivery system.The procedure was completed successfully.The patient was discharged at the time of report.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
An event of device deformity was reported.The investigation found 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.Two images were received from field that appeared to show a deformed distal disc of an occluder device partially deployed in a cobra like structure and connected to the delivery system.The cause of the reported event could not be conclusively determined.Please note that per the instructions for use, the recommended size delivery system for use with a 13 mm amplatzer septal occluder is an 7f.

• 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: 14494133
• Report Number: 2135147-2022-00313
• Device Sequence Number: 6008690
• Product Code: MLV
• UDI-Device Identifier: 05415067019219
• UDI-Public: 05415067019219
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 07/13/2022

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: 08/31/2024
• Device Model Number: 9-ASD-013
• Device Catalogue Number: 9-ASD-013
• Device Lot Number: 7202161
• 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: 04/27/2022
• Supplement Date Received by Manufacturer: 06/13/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2019
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV09F45/80.
• Patient Sex: Unknown