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

Catalog Number	9-AVP038-008
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
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) 2024, a 8mm amplatzer vascular plug iv was chosen for implantation into atrial septal defect (asd) and patent foramen ovale (pfo) with significant protrusion into the aorta utilizing a non-abbott delivery system.An amplatzer sizing balloon ii was used to size the defect.After release of the 8mm amplatzer vascular plug iv, the device was thought to be too large by the physician.The device was retrieved with a bioptome.A replacement 6mm amplatzer vascular plug iv was then implanted successfully with an unknown delivery system.There were no adverse patient effects and no clinically significant delay.No additional information was provided.
Event or Problem Description
It was reported that on (b)(6) 2024, a 8mm amplatzer vascular plug iv was chosen for implantation into atrial septal defect (asd) and patent foramen ovale (pfo) with significant protrusion into the aorta utilizing a non-abbott delivery system.An amplatzer sizing balloon ii was used to size the defect.After release of the 8mm amplatzer vascular plug iv, the device was thought to be too large by the physician.The device was retrieved with a bioptome.A replacement 6mm amplatzer vascular plug iv was then implanted successfully with non-abbott delivery system.There were no adverse patient effects and no clinically significant delay.The patient remained hemodynamically stable throughout the procedure.
Additional Manufacturer Narrative
An event of avp iv device thought to be too large was reported.A returned device assessment could not be performed as the device and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Information from field indicated that an 8 mm amplatzer vascular plug iv was chosen for implantation into atrial septal defect (asd) and patent foramen ovale (pfo) with significant protrusion into the aorta utilizing a non-abbott delivery system.Please note that per the instrcutions for use, "the amplatzer¿ vascular plug 4 is indicated for arterial and venous embolizations in the peripheral vasculature.".

• 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: 18685724
• Report Number: 2135147-2024-00604
• Device Sequence Number: 20395619
• Product Code: KRD
• UDI-Device Identifier: 00811806012384
• UDI-Public: 00811806012384
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K113658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 03/12/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 9-AVP038-008
• Device Lot Number: 8159643
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 02/12/2024
• Supplement Report FDA Received Date: 03/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2021
• 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