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

Catalog Number	9-PLUG-012
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Angina (1710)
Date of Event	11/09/2023
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
It was reported that on (b)(6) 2023, a 12mm amplatzer vascular plug was implanted in the left subclavian artery (lsa) for thoracic endovascular aneurysm repair (tevar) with a 8f non-abbott guiding catheter.It was reported the vessel diameter was 8mm and echocardiography confirmed successful implant with complete occlusion of blood flow.After 1 month post-procedure on (b)(6) 2023, the patient experienced persistent chest discomfort.It was later reported that on (b)(6) 2023, an echocardiography revealed an endoleak of blood flow in the lsa.It was then reported on (b)(6) 2023, a decision was made to additionally implant a non-abbott device in the lsa.The patient status was reported as stable.
Additional Manufacturer Narrative
An event of persistent chest discomfort after one month of implant and endo leak of blood flow in the lsa was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Two videos and one image were received from field.Angiogram of left subclavian artery showed a diameter of 7 to 8 mm.Injecting from the distal left arm into the left subclavian artery showed residual flow around the previously placed avp ii.Injection demonstrated an endo leak.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from field indicated that a decision was made to additionally implant a non-abbott device in the lsa.Based on the information received, the cause of the reported incident could not be conclusively determined.There were no complaints associated with any other devices from the lot.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER VASCULAR PLUG
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 18256836
• Report Number: 2135147-2023-05318
• Device Sequence Number: 17939841
• Product Code: KRD
• UDI-Device Identifier: 00811806011486
• UDI-Public: 00811806011486
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K031810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PLUG-012
• Device Lot Number: 8713991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 01/25/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown