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

Catalog Number	9-AVP2-016
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of device detaching from the delivery cable and embolizing in the left ventricle was reported.Information from the field indicated that the defect was measured using echo, ct fusion, and fluoro.A returned device assessment 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 but could be due to the tortuous nature of the defect and removal of delivery system.
Event or Problem Description
It was reported that on 17 jan.2024, a 10mm and 16mm amplatzer vascular plug ii was selected for implant the dimension of the defect measured -8mm x 6mm and was done by echo, ct fusion, and fluoro.During the procedure, the 10mm amplatzer vascular plug ii device became detached after the sheath was removed and embolized in the left ventricle.The physician tried to implant a 16mm amplatzer vascular plug ii but also embolized in the left ventricle.The devices were both snared nothing remained in the patient.The procedure was completed with another 16mm amplatzer vascular plug ii.There were no adverse patient effects and no clinically significant delay in the procedure.

• 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: 18669121
• Report Number: 2135147-2024-00580
• Device Sequence Number: 12587180
• Product Code: KRD
• UDI-Device Identifier: 00811806010410
• UDI-Public: 00811806010410
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Catalogue Number: 9-AVP2-016
• Device Lot Number: 7775618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2020
• 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 Age: 80 YR
• Patient Sex: Male
• Patient Weight: 72 KG