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

Model Number	9-AVP2-022
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Gastrointestinal Hemorrhage (4476); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer vascular plug ii was implanted in the patient for retrograde transvenous obliteration (parto).After the procedure, the patient passed away.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of gastrointestinal hemorrhage with a patient outcome of death was reported.A medical review was completed and concluded that the exact cause of death is unknown.Since the fatality occurred 10 days post implant and there is no report of any complications, most likely the death is related to underlying comorbidities of the patient.A returned device assessment could not be performed as the device remains implanted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.There were no complaints associated with any other devices from the lot.Based on the available information, the cause for the reported gastrointestinal hemorrhage with a patient outcome of death could not be confirmed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect-clinical code: 4582 no clinical signs, symptoms or conditions.
Event or Problem Description
It was reported that on (b)(6) 2025, a 22mm amplatzer vascular plug ii was implanted in the patient for retrograde transvenous obliteration (parto).The plug was successfully implanted.On (b)(6) 2025, the patient was reported passed away.The cause of death was gastrointestinal (gi) bleeding.

• 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: 23378754
• Report Number: 2135147-2025-06062
• Device Sequence Number: 9202096
• Product Code: KRD
• UDI-Device Identifier: 00811806010441
• UDI-Public: (01)00811806010441(17)300430(10)10871562
• Combination Product (Y/N): N
• Initial Reporter State: PR
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/04/2025

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 Model Number: 9-AVP2-022
• Device Catalogue Number: 9-AVP2-022
• Device Lot Number: 10871562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/19/2025
• 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: Death
• Patient Age: 56 YR
• Patient Sex: Female