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

Catalog Number	9-ASD-019
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	07/11/2023
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) 2023, a 19mm amplatzer septal occluder was chosen for implant to treat atrial septal defect (asd), using 9f amplatzer trevisio intravascular delivery system.The asd was measured to be 1.7x1.3mm using transesophageal echocardiography (toe).The case was performed under intracardiac echocardiography (ice) control.A 24mm sizing balloon was inflated to 17ml to stop flow on ice images.Waist of balloon was measured to be 15.9mm on fluoroscopy.Ice image measures 16.2mm.Sizing plate used with balloon inflated to 17ml.Balloon was tight at 18mm measuring hole.During deployment of the device, the left disc immediately formed a cobra head.The device was re-sheathed and removed, and it remained in a cobra head deformity outside the patient.There was no angulation or kink noticed in the delivery system.There was no interaction with cardiac structures during deployment.A replacement 20mm amplatzer septal occluder was deployed with no reported issue.The patient was reported to be stable and recovering.The patient remained hemodynamically stable throughout the procedure.This issue reportedly caused a clinically significant delay, but the delay did not result in adverse patient sequelae.
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.Information from the field indicated that there was no anatomical interference, there was no angulation or kink in the delivery system upon deployment, and an 9f delivery system was used.Additionally, a photo was received from the field and the photo appeared to show the device deformity (cobra head).However, it could not be confirmed as there was no cobra head deformity during the returned device analysis.Based on the available information, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 17454856
• Report Number: 2135147-2023-03397
• Device Sequence Number: 17978870
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: 00811806010168
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 10/17/2023

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 Catalogue Number: 9-ASD-019
• Device Lot Number: 8727221
• 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: 07/11/2023
• Supplement Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 80 KG