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

Model Number	VASCULAR PLUG 4
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2023, a 4mm amplatzer vascular plug iv was implanted.After the procedure, the 4mm amplatzer vascular plug iv had migrated.The vessel they tried to embolize was measured as 3.59mm.The instructions inside the packet said to use a 4mm plug.When they checked online, it said to use a 5mm plug.The device was snared to resolve the event.
Event or Problem Description
It was reported that on (b)(6) 2023, a 4mm amplatzer vascular plug iv was implanted.The vessel they tried to embolize was measured as 3.59mm.Reportedly, the instructions inside the packet said to use a 4mm plug when the vessel diameter was up to 4mm.After the procedure, the 4mm amplatzer vascular plug iv had migrated.The device was snared to resolve the event.The online instructions were checked post migration, and it was said to use a 5mm plug for that size defect.The original instructions provided that recommended to use a 4mm plug for a vessel measured as 3.59mm were not able to be obtained.
Additional Manufacturer Narrative
An event of device migration was reported.Field indicated that the vessel diameter was 3.59 mm.Amplatzer plug sales sheet was received from field that contained ordering information for amplatzer¿ vascular plugs and indicated 5 mm device for 3.5-4.0 mm vessel diameter range; these instructions were not able to be provided.No printed version of the instructions for use was included in the device box, the electronic instructions for use, for this device indicates to "select a device that is appropriately 30%¿50% larger in diameter than the corresponding vessel diameter." which would be a 5mm plug.A returned device inspection, to rule out any device-related causes, could not be performed as the device 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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 17204343
• Report Number: 2135147-2023-02784
• Device Sequence Number: 5684564
• Product Code: KRD
• UDI-Device Identifier: 00811806012346
• UDI-Public: 00811806012346
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K113658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 08/03/2023

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: VASCULAR PLUG 4
• Device Catalogue Number: 9-AVP038-004
• Device Lot Number: 8920423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 08/01/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown