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

Model Number	9-PLUG-008
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not returning for evaluation.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) 2025, a 8mm amplatzer vascular plug was selected for implant.During the procedure, the plug deployed within the sheath on its own.A 10mm amplatzer vascular plug 2 used instead to resolve the event.There was no clinically significant delay reported.
Additional Manufacturer Narrative
An event of premature separation during procedure was reported.A returned device inspection, to rule out any device-related causes, could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated that, the plug deployed within the sheath on its own.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the information received and without the device to analyze, the cause of the reported premature separation of device could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture design or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, a 8mm amplatzer vascular plug was selected for implant.During the procedure, the plug deployed within the sheath on its own.A 10mm amplatzer vascular plug 2 used instead to resolve the event.There was no clinically significant delay reported.

• 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: 22387534
• Report Number: 2135147-2025-03638
• Device Sequence Number: 12927420
• Product Code: KRD
• UDI-Device Identifier: 00811806011462
• UDI-Public: (01)00811806011462(17)280331(10)9015180
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K031810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 9-PLUG-008
• Device Catalogue Number: 9-PLUG-008
• Device Lot Number: 9015180
• 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: 06/11/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2023
• 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
• Patient Sex: Unknown