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

Model Number	9-ASD-022
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	11/17/2022
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)(4) 2022, a 22mm amplatzer septal occluder was chosen for implant using a 9f amplatzer trevisio intravascular delivery system.There were no kinks or angulation noticed in the delivery system.During the first attempt to deploy the device in the patient body, it deployed in a cobra deformation shape.The device was placed in hot saline but did not revert back to its usual shape.A 20mm amplatzer septal occluder (8392162) was then successfully implanted.There was no clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient was discharged 24 hours after the procedure.
Additional Manufacturer Narrative
An event of device deformed into cobra shape 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 defined manufacturing specifications.One image from field appeared to show an distal disc of occluder device deformed in cobra shape when deployed through loader.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Subsequent to the initially filed report, the following information was received that the device was never released from the delivery cable while inside the patient.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2022, a 22mm amplatzer septal occluder was chosen for implant using a 9f amplatzer trevisio intravascular delivery system.There were no kinks or angulation noticed in the delivery system.During the first attempt to deploy the device in the patient body, it deployed in a cobra deformation shape.The device was placed in hot saline but did not revert back to its usual shape.A 20mm amplatzer septal occluder ((b)(6) was then successfully implanted.There was no clinically significant delay.The patient remained hemodynamically stable throughout the procedure.The patient was discharged 24 hours after the procedure.Subsequent to the initially filed report, the following information was received that the device was never released from the delivery cable while inside the patient.
Additional Manufacturer Narrative
An event of device deformity could not be confirmed.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.The correct delivery system was used, there was no anatomical interference, and no angulation or kink in the delivery system was reported.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: 15960974
• Report Number: 2135147-2022-02497
• Device Sequence Number: 5668816
• Product Code: MLV
• UDI-Device Identifier: 05415067019295
• UDI-Public: 05415067019295
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 05/23/2023

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 Model Number: 9-ASD-022
• Device Catalogue Number: 9-ASD-022
• Device Lot Number: 8481880
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 02/08/2023; 05/03/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 02/20/2023; 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2022
• 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
• Patient Sex: Unknown