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

Catalog Number	9-AVP2-018
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cognitive Changes (2551)
Date of Event	06/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2024, a 18mm amplatzer vascular plug 2 was successfully implanted in a patient.Post-procedure, it was noted that the patient began to experience periods of both hypo and hyperactive delirium.The patient was hospitalized for monitoring of condition.There was no intervention performed.The patient was discharged 6 days post-procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Subsequent to the previously filed report, additional information was received that the patient remain hemodynamically stable throughout the procedure.There was no difficulty implanting the 18mm amplatzer vascular plug 2.The patient was administered zopiclone for their hypo and hyperactive delirium.The patient reported a lapse in memory from (b)(6) 2024.The cause of the patient's hypo and hyperactive delirium is unknown, but the patient's age at the time of procedure was a known major risk factor.It was noted that the patient also has a history of memory deficits.There is no allegation of malfunction against the abbott device or procedure.
Additional Manufacturer Narrative
An event of hypo and hyperactive delirium was reported.A returned device assessment could not be performed as the device remains implanted and 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.The reported unexpected medical intervention was result of case specific circumstance as medications were administered.The lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.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 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: 19811161
• Report Number: 2135147-2024-03546
• Device Sequence Number: 12857060
• Product Code: KRD
• UDI-Device Identifier: 00811806010427
• UDI-Public: (01)00811806010427(17)270228(10)8374019
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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-AVP2-018
• Device Lot Number: 8374019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/23/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/09/2022
• 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