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

Catalog Number UNK AMPLATZER VASCULAR PLUG II

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Adult Respiratory Distress Syndrome (1696); Pulmonary Edema (2020); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/20/2023

Event Type  Injury  

Event Description

The article, "chief complaint: paroxysmal respiratory distress caused by light exertion" was reviewed.This research article is a single center experience to evaluate paroxysmal respiratory distress caused by light exertion.The patient suffered from combined valvular disease and underwent double valve replacement in which 2 non-abbott valves were implanted.On an unknown date, two 8mm amplatzer vascular plug ii were implanted due to paravalvular leak (pvl).The pvl was almost resolved and the patient reported improved conditions.After an unspecified amount of time, respiratory distress with light exertion and acute pulmonary edema developed again.The symptoms were temporarily improved with diuretic control, however respiratory distress deteriorated further.Uncompensated heart failure caused by mitral valve insufficiency was diagnosed.It was diagnosed that the leaflet had inadequate opening due to interference by the implanted plug, which was protruding into the left ventricular outflow tract.Cardiac computed tomography (ct) was negative for thrormbus, pannus, and vegetation.Redo mitral valve procedure was recommended, however the patient did not consent and was transferred to another facility for conservative cares.[the author of this article is akira fujii, md, hoshinookashinzo kekkan clinic, 1 chome-5-5 higashiishii, matsuyama, ehime 790-0932, japan].

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

As reported in a research article uncompensated heart failure caused by mitral valve insufficiency was diagnosed.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Type of Device: 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: 16564291
• MDR Text Key: 311491912
• Report Number: 2135147-2023-01232
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER VASCULAR PLUG II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female