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

Catalog Number EC500F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

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 three years and three months later, computed tomography of chest with contrast and abdomen with and without contrast was performed which revealed there was an inferior vena cava filter in the infra renal position of the vena cava.After one month and two weeks, computed tomography of chest and abdomen was performed which showed inferior vena cava filter present.After one-month, computed tomography of abdomen and pelvis with and without contrast was performed which showed there was an infra renal inferior vena cava filter with legs of the filter appearing to project outside the inferior vena cava.After eight months, computed tomography of chest and abdomen with contrast was performed which showed there was an inferior vena cava filter in place.After ten months, computed tomography of abdomen and pelvis with and without contrast was performed and the patient was diagnosed with back pain.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava.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 after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter perforated the inferior vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient experienced pain in abdomen; however, the current status of the patient is unknown.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• 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: 12126917
• MDR Text Key: 260215918
• Report Number: 2020394-2021-80540
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/07/2021
• 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 Weight: 119