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

Model Number	SEPTAL OCCLUDER
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	02/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 6mm amplatzer septal occluder was chosen for implant on (b)(6) 2022.During the procedure, in an attempt to deploy the device, the occluder present with a cobra shape deformation.Still connected to the cable, the device was removed.A new 6mm amplatzer septal occluder was successfully implanted.It was noted that there was a 15 delay in the procedure that was not clinically significant.The patient remained stable, no adverse events reported.The patient was discharged the same day.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Subsequent to the initially filed report, the following information was received on 16 april 2022.It was reported that there was no device restraints by anatomical structures.The occluder was not larger than recommended by the delivery sheath size.There was no angulation or kink in the delivery system.No additional information was provided.
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.No indication of a lot related issue was found.The cause of the reported event 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: 13946145
• Report Number: 2135147-2022-00110
• Device Sequence Number: 6505586
• Product Code: MLV
• UDI-Device Identifier: 00811806010038
• UDI-Public: 00811806010038
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2022

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: 04/30/2026
• Device Model Number: SEPTAL OCCLUDER
• Device Catalogue Number: 9-ASD-006
• Device Lot Number: 7981785
• 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: 03/04/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 03/30/2022
• Supplement Report FDA Received Date: 05/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2021
• 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
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Race: White