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	Low Blood Pressure/ Hypotension (1914); Hemolytic Anemia (2279); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/08/2023
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
Clinical information: (b)(6), patient site id:(b)(6).It was reported that on (b)(6) 2023, a 10 mm x 5 mm amplatzer valvular plug 3 was selected for procedure in attempt to occlude a moderate perivalvular leak/mild aortic regurgitation of a non-abbott device.The patient was placed under general anesthesia for procedure.The 10 mm x 5 mm amplatzer valvular plug 3 was advanced through the delivery sheath, oriented in the left ventricle cavity, and deployed within the perivalvular leak.Multiple attempts were made with mostly good orientation, but the regurgitation/leak was little changed and the proximal disc was seen to interfere with the non-abbott aortic valve leaflet.Despite multiple attempts with the plug in different positions, a satisfactory position could not be achieved.The 10 mm x 5 mm amplatzer valvular plug 3 was removed and a 12mm x 5mm amplatzer valvular plug 3 was similarly positioned and again, despite multiple attempts, regurgitation could not be extinguished and the proximal disc again interfered with the non-abbott aortic valve leaflet.The 12mm x 5mm amplatzer valvular plug 3 was removed, and several attempts were made to position two 8 mm amplatzer vascular plug 2 simultaneously by advancing one of to the left ventricle and another one alongside it.However, both 8 mm amplatzer vascular plug 2 had similar results and were not implanted.A total of 4 amplatzer plugs were attempted for implant, but none were implanted.It was also noted that only one non-abbott delivery sheath was used tp the procedure.The patient did not have a tortuous anatomy.It was noted post-procedure that the patient had hypotension and hemolytic anemia.The hypotension is suspected to be caused by the combination effects of anesthesia and the patient's at home blood pressure medication.It was also noted that an apparent worsening of perivalvular leakage/ severe aortic regurgitation could also have contributed to the patient's hypotension.The hemolytic anemia is attributed to the worsening perivalvular leakage.A computed tomography angiogram was performed and found no active bleeding.The decision was made to administer the patient levophed and transfuse the patient with red blood cells.There is no allegation of malfunction against the abbott devices or procedure.The patient was discharged at the time of report.
Additional Manufacturer Narrative
An event of regurgitation, hypotension and hemolytic anemia was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER VASCULAR PLUG II
• 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: 17713027
• Report Number: 2135147-2023-03911
• Device Sequence Number: 6731452
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: 00811806010373
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• 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: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2023

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: 8446728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2023
• Supplement Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2022
• 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