MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG 4; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	9-AVP038-007
Medical Device Problem Codes	Separation Problem (4043); Premature Separation (4045)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on (b)(6) 2025 a 7mm amplatzer vascular plug iv was selected for implant.During implant the plug could not be deployed due to the screw mechanism.While attempting to remove the plug from the patient the plug released within the delivery catheter.The plug was able to be removed from the patient through the delivery catheter.There was a clinically significant delay to the procedure as the patient continued to actively bleed.The patient status was unknown.
Additional Manufacturer Narrative
An event of separation problem and premature separation was reported with a patient effect of bleeding.The guidewire and vise were returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.A returned device assessment could not be performed on the plug as it 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 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 separation problem and patient effect of bleeding, could not be determined.The reported premature separation likely resulted from the attempt made to release the device (unscrewing the delivery cable), however this cannot be determined.A minor injury was a result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported on (b)(6) 2025 a 7mm amplatzer vascular plug iv was selected for implant.During implant the plug could not be deployed due to the screw mechanism.While attempting to remove the plug from the patient the plug released within the delivery catheter.The plug was able to be removed from the patient through the delivery catheter.There was a clinically significant delay to the procedure as the patient continued to actively bleed.The patient status was unknown.

• Brand Name: AMPLATZER VASCULAR PLUG 4
• 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: 23633193
• Report Number: 2135147-2025-06883
• Device Sequence Number: 13090609
• Product Code: KRD
• UDI-Device Identifier: 00811806012377
• UDI-Public: (01)00811806012377(17)300228(10)10768622
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 01/28/2026

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-AVP038-007
• Device Catalogue Number: 9-AVP038-007
• Device Lot Number: 10768622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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
• Patient Sex: Unknown