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

Model Number	9-PLUG-016
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An event of device embolization into the right ventricle was reported.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined but the combination of an undersized device being "nudged" may have contributed to the device embolization.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.
Event or Problem Description
It was reported that a 16mm amplatzer vascular plug was selected for an implant on (b)(6) 2022.The device was successfully implanted.A second unknown plug was placed proximal to the 16mm amplatzer vascular plug.The unknown plug bumped into the 16mm amplatzer ,causing it to migrate from the right hepatic vein and ended up in the right ventricle.The amplatzer device successfully retrieved via jugular access & snare.The unknown plug remained implanted.The patient was reported to be in stable condition.

• 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: 14891728
• Report Number: 2135147-2022-00460
• Device Sequence Number: 20131033
• Product Code: KRD
• UDI-Device Identifier: 00811806011509
• UDI-Public: 00811806011509
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K031810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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
• Report Date (Section B): 07/01/2022

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: 06/30/2026
• Device Model Number: 9-PLUG-016
• Device Catalogue Number: 9-PLUG-016
• Device Lot Number: 8045934
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2021
• 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