MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM; VENA CAVA FILTER

Catalog Number RF048F

Device Problems Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 05/08/2010

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five years and four months later, the patient came to the hospital with severe chest pain and had syncope.Cardiac catheterization, which showed evidence of double vessel coronary artery disease.The patient had an echocardiogram done emergently on the table which showed evidence of cardiac tamponade.After the next day, a computed tomography angio (cta) aorta with and without contrast was performed and it revealed a 2 cm linear metallic structure in the region of the myocardial septal wall which may be the etiology for the pericardial effusion.This structure probably represents one of the outer prongs of the inferior vena cava filter.After the next day, a chest single view was performed, and compared to the prior study shows new linear radiopaque opacities projecting over the right side of the heart.After the next day, the patient scheduled for the filter strut removal.A median sternotomy was carried out following which pericardium was opened.Following this, the right ventricle was mobilized upwards and there was evidence of foreign body perforating through the diaphragmatic surface of the right ventricle and this was extracted from the right ventricle.This was extracted for an inferior vena cava filter which was taken out and sent for pathological analysis.Following this, cross-clamp was placed and antegrade and retrograde cardioplegia was given.After the electromechanical arrest of the heart, a bypass was done to the posterior descending artery as well as to the obtuse marginal branch of the circumflex coronary artery.Therefore, the investigation is confirmed for alleged filter limb detachment.However, the investigation is inconclusive for the perforation of the inferior vena cava (ivc).Based on the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter struts detached and perforated into the organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The detached struts was removed via open chest procedure; however, the current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10198919
• MDR Text Key: 196584567
• Report Number: 2020394-2020-04073
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2020
• 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
• Treatment: AMLODIPINE, ASPIRIN, ATORVASTATIN, DIVALPROEX; DOCUSATE SODIUM, HEPARIN SODIUM, INSULIN; LACOSAMIDE, METFORMIN; PANTOPRAZOLE AND SITAGLIPTIN
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 88