MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	9-AVP2-008
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Heart Failure/Congestive Heart Failure (4446); Insufficient Information (4580)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: crd_967 - paradigm, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 8x4 mm amplatzer valvular plug iii was chosen for a procedure.During procedure, the device interacted with the mechanical disk of an unknown aortic mechanical valve.The decision was made to percutaneously explant the 8x4 mm amplatzer valvular plug 3.An 8mm amplatzer vascular plug 2 was prepared for procedure and released from the delivery cable.However, the decision was made to also percutaneously explant the 8mm amplatzer vascular plug 2 due to an unknown reason.
Additional Manufacturer Narrative
H6 health effect - clinical code 4580 was removed.H6 health effect - impact code 4641 was removed.An event of unable to implant the device and off-label use 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 specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no allegation of malfunction against the abbott devices or procedure.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Per the instructions for use, amplatzer vascular plug ii, arten600196858, revision 1.12, stated "intended use: the amplatzer¿ vascular plug ii is indicated for arterial and venous embolizations in the peripheral vasculature." this is considered as an off-label use of the device.However, it was unable to determine if the off-label use contributed to the reported incident.In addition, the implanting physician was aware the amplatzer vascular plug ifu.Therefore, a letter will not be sent out to the accountant.
Event or Problem Description
Subsequent the previously filed report, additional information was received and a correction needs to be made as both the 8x4 mm amplatzer valvular plug 3 and 8mm amplatzer vascular plug 2 were never released from their respective delivery cables.Both plugs were able to be safely removed after they were deemed inadequate for perivalvular leak reduction.The patient remain hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure reported.There is no allegation of malfunction against the abbott devices or procedure.The patient had trivial perivalvular leakage and class 1 new york heart failure symptoms at the time of report.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 20271049
• Report Number: 2135147-2024-04658
• Device Sequence Number: 11630376
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: (01)00811806010373(17)280331(10)8980997
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-AVP2-008
• Device Lot Number: 8980997
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/11/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2023
• 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
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White