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

Catalog Number EC500F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); No Consequences Or Impact To Patient (2199)

Event Date 09/19/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one month post filter deployment, computed tomography revealed the filter was in below the left renal vein.One of the legs at about the 11'o clock position may be penetrated the wall of the cava and another one may be penetrated about the 3 to 4'o clock position.Tiny rind of retroperitoneal hematoma was identified.Approximately five years three months later, computed tomography revealed the filter with more extensive leg perforation of inferior vena cava, and more tilt than on prior study.Approximately three years later, filter was retrieved successfully.Therefore, the investigation is confirmed for filter tilt and perforation of the inferior vena cava (ivc).Based upon 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.(expiry date: 10/2013).

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 and pulmonary embolism.Approximately five years and three months later post filter deployment, it was alleged that the filter tilted, and struts perforated.The device has been removed percutaneously.The patient was diagnosed with hematoma; however, the current status of the patient is unknown.

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 and pulmonary embolism.Approximately five years and three months later post filter deployment, it was alleged that the filter tilted and struts perforated.The device has been removed percutaneously.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one month post filter deployment, computed tomography revealed the filter was in below the left renal vein.One of the legs at about the 11'o clock position may be penetrated the wall of the cava and another one may be penetrated about the 3 to 4'o clock position.Tiny rind of retroperitoneal hematoma was identified.Approximately five years three months later, computed tomography revealed the filter with more extensive leg perforation of inferior vena cava, and more tilt than on prior study.Approximately three years later, filter was retrieved successfully.Therefore, the investigation is confirmed for filter tilt and perforation of the inferior vena cava (ivc).Based upon 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.H10: d4 (expiry date: 10/2013), g4 h11: b1, b5, h1, h6 (patient, results) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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
• MDR Report Key: 10366528
• MDR Text Key: 201660484
• Report Number: 2020394-2020-05239
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• 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: GFUI2730
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR