MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER ADOII 6MM DIA 4MM LG PKG STER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number	9-PDA2-06-04
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	12/19/2023
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 a 6mm amplatzer duct occluder ii was selected for implant on (b)(6) 2023 using a 5f amplatzer torqvue lp.During the procedure the device took on a cobra shape.The device was replaced with a new amplatzer vascular plug ii.There were no interactions with cardiac structures.There were no angulations or kinks noted in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.The patient status was stable.There were no adverse effects to the patient.
Additional Manufacturer Narrative
An event of device deformity was reported.A returned device inspection 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.There were no complaints associated with any other devices from the lot.Information from the field indicated that there was no anatomical interference, or any angulation or kink in the delivery system upon deployment and a 5f size delivery system was used.Additionally, photo was received from the field and it appears to show the device deformity.Based on the information received, the cause of the reported device deformity could not be conclusively determined.Na.

• Brand Name: AMPLATZER ADOII 6MM DIA 4MM LG PKG STER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18497922
• Report Number: 2135147-2024-00203
• Device Sequence Number: 8146461
• Product Code: MAE
• UDI-Device Identifier: 00811806011257
• UDI-Public: 00811806011257
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: P020024
• 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): 01/18/2024

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: 02/28/2025
• Device Catalogue Number: 9-PDA2-06-04
• Device Lot Number: 7422840
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2020
• 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: 5F AMPLATZER TORQVUE [9-TVLP5F90/080 LOT:8630227]
• Patient Sex: Unknown