MAUDE Adverse Event Report: WILLIAM COOK EUROPE; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Catalog Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Angina (1710); Chest Pain (1776); Dyspnea (1816); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

According to article: inferior vena cava (ivc) filters have been associated with multiple complications.We present a case of an elderly female who presented 8 years after the filter implantation and was found to have developed pericardial effusion secondary to filter fracture and migration of the strut to the intercostal space.A (b)(6) year-old female presented with severe angina mimicking chest pain for two weeks.Her past medical history was significant for implantation of a cook celect retrievable ivc filter (> 8 years ago).She had been lost to follow up.Labs revealed troponin i of 0.06 ng/ml.An ekg showed atrial flutter with variable atrio-ventricular block.Chest x-ray revealed a metallic foreign body at the left of midline and along the anterior chest wall below the level of the sternum.A ct angiogram demonstrated a large pericardial effusion measuring 2.5 cm.At the anterior margin of the pericardium, extending into the anterior soft tissues of the chest wall was a linear density.However, the metallic object was not to be located in the right ventricle and the tip was suggested to be in the pericardium.The foreign body was considered a fragment of the ivc filter.The patient's symptoms of chest pain and dyspnea were considered to occur when the filter was migrating through the pericardium and the pain became sharper once it was embedded in the intercostal space.An urgent subxiphoid pericardial window for removal of the foreign body was performed along with xiphoidectomy.Fluoroscopy indicated that the metallic fragment was an ivc filter fragment and was embedded in the sixth intercostal space along the left side.It was then removed along with evacuation of 250 cc of bloody fluid.

• Type of Device: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 12302055
• MDR Text Key: 265852001
• Report Number: 3005580113-2021-00096
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/10/2021
• Distributor Facility Aware Date: 07/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/10/2021
• 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): Required Intervention
• Patient Age: 71 YR