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

Model Number	9-ASD-017
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	04/29/2022
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 a 17mm amplatzer septal occluder had been chosen for procedure on (b)(6) 2022 using an 8 f delivery system.During the procedure, the device presented with a deformation.It was noted that the device was re-sheathed five times, the device was retrieved.The device attempted again but the deformation persisted.It was noted that there was a delay in procedure but that the patient remained stable throughout the procedure.The device was removed and exchanged with a new 17mm amplatzer septal occluder, that was successfully implanted.The patient was noted have been discharged at the time of report.
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.However, three photos were received which appeared to show a bloody occluder in a cobra conformation.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined but may have been caused by attempting to implant the device with a larger than recommended delivery system and attempting to deploy the device more than two times.Please note, per the amplatzer septal occluder instructions for use: "warnings: do not release the device from the delivery cable if the device does not conform to its original configuration or if the device position is unstable or if the device interferes with any adjacent cardiac structure, such as superior vena cava (svc), pulmonary vein (pv), mitral valve (mv), coronary sinus (cs) or aorta (ao).Recapture the device and redeploy.If still unsatisfactory, recapture the device and replace with a new device." table 1: the recommended size delivery system for use with a 17mm amplatzer septal occluder is a 7f.Na.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that there was no anatomical interference when the occluder was deployed.There were no kinks or angulation in the delivery system when the occluder was deployed.There was no clinically significant delay.

• 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: 14598670
• Report Number: 2135147-2022-00341
• Device Sequence Number: 5811221
• Product Code: MLV
• UDI-Device Identifier: 05415067019257
• UDI-Public: 05415067019257
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 08/03/2022

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: 06/30/2026
• Device Model Number: 9-ASD-017
• Device Catalogue Number: 9-ASD-017
• Device Lot Number: 8076251
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2021
• 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 Sex: Unknown