MAUDE Adverse Event Report: BARD IVC FILTER

Device Problems Fracture (1260); Patient-Device Incompatibility (2682)

Patient Problems Abdominal Pain (1685); Adhesion(s) (1695); Chest Pain (1776); Tissue Damage (2104); Disability (2371); Cardiac Perforation (2513); Intermenstrual Bleeding (2665); Heavier Menses (2666)

Event Date 01/11/2015

Event Type  Injury  

Event Description

Patient is (b)(6) who presented to our hospital with acute onset chest pain on (b)(6) 2015.He underwent cardiac catheterization to rule out coronary issues; however, his coronary arteries were completely normal.On the catheterization, he was noted to have a metallic object in his right ventricle.This was soon identified to be a fragment of the previously placed ivc filter.The leg of the ivc filter was penetrating through intraventricular septum close to the interior wall of the heart.Another leg had embolized into his right lung in a very distal pulmonary artery.Per patient, multiple years previously, he had placement of a bard ivc filter at an outside facility.Date of placement is unknown.The filter removal required 2 procedures.The first procedure in the intravaginal vascular lab removed most of the broken filter.The intracardiac foreign body was removed in the operating room.Patient tolerated the procedure well.This patient presented at our facility with the filter already fractured.We did not place the device here so we don't have knowledge, beyond with the patient is reporting, on when the device was placed.

• Brand Name: BARD IVC FILTER
• Type of Device: NA
• MDR Report Key: 4994694
• MDR Text Key: 22909366
• Report Number: 4994694
• Device Sequence Number: 1
• Product Code: DTK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Report Date: 07/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/11/2015
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 74