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U.S. Department of Health and Human Services

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

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WILLIAM COOK EUROPE DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
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.

 
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Type of DeviceDTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
WILLIAM COOK EUROPE
sandet 6
bjaeverskov 4632
DA 4632
MDR Report Key12302055
MDR Text Key265852001
Report Number3005580113-2021-00096
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
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 Received08/10/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberUNKNOWN
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2021
Distributor Facility Aware Date07/19/2021
Event Location Hospital
Date Report TO Manufacturer08/10/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/10/2021 Patient Sequence Number: 1
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