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

Model Number	9-AVP2-008
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Tachycardia (2095)
Type of Reportable Event	Serious Injury
Event or Problem Description
The article "early spontaneous closure of large arterial ducts in two term neonates with ebstein anomaly after failed attempts of transcatheter closure" was reviewed.The research article presents a case study of a 9 day old female patient with with ebstein¿s anomaly of the tricuspid valve and a significant arterial duct.The pulmonary end of the arterial duct was 6.3mm, and the length was 8.9mm.An 8mm amplatzer vascular plug ii was chosen to close the arterial duct using a 5f jr 3.0 launcher coronary guide catheter (manufacturer: medtronic).A residual shunt was observed and the device was not stable in the defect, so the device was removed prior to release from the delivery cable.The catheter was exchanged to 6f, during which the patient experienced two episodes of ventricular tachycardia.A cardioversion was required.A 10mm amplatzer vascular plug ii was then attempted for implant, but the delivery was laborious.The procedure was aborted due to access-related bleeding noted.Two days following the procedure, there was a spontaneous complete ductal closure, and the patient had a good final clinical outcome.The primary author of the article is raymond n.Haddad, hôpital universitaire necker-enfants malades, 149, rue de sèvres, 75015, paris, france.The correspondence email is raymondhaddad@live.Com.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Na.
Additional Manufacturer Narrative
As reported in a research article, an event of residual shunt and ventricular tachycardia was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review, and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The use of the device in a position not recommended in the instructions for use could have contributed to the reported event.Please note, per the instructions for use, "the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established.

• 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: 16704485
• Report Number: 2135147-2023-01533
• Device Sequence Number: 5719398
• Product Code: KRD
• UDI-Device Identifier: 00811806010373
• UDI-Public: 00811806010373
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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 Model Number: 9-AVP2-008
• Device Catalogue Number: 9-AVP2-008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Age: 9 DA
• Patient Sex: Female
• Patient Weight: 3 KG