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 Problem Abdominal Pain (1685)

Event Date 05/15/2012

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 weeks later, computed tomography of abdomen and pelvis was performed which revealed an inferior vena cava filter was present.After eight months, patient had abdominal pain with consistent heart burn.After three months, computed tomography of pancreas with contrast was performed which revealed an inferior vena cava filter was present with tip below the level of the renal veins.After four months, the patient had abdominal pain and gastroesophageal reflux disease.After three weeks, abdominal series was performed for abdominal pain and which also revealed an inferior vena cava filter.After five months, patient had abdominal pain, computed tomography of abdomen and pelvis with contrast was performed which revealed an inferior vena cava filter.After one year and one-month, computed tomography of abdomen and pelvis with contrast was performed which revealed an inferior vena cava filter with some of the struts extending beyond the inferior vena cava margin.After three years and four months, computed tomography of abdomen without contrast was performed and inferior vena cava filter was present with its cranial tip approximately 1.9cm below the right renal vein.This tip abuts the lateral wall of the inferior vena cava.It was angled 19 degree rightward in the coronal plane.Its struts appear intact.However, several struts partially perforate through the posterior and medial walls of the inferior vena cava.The majority of these perforated segments reside within retroperitoneal fat (with greatest perforation 17mm) although one strut appears to perforate the right lateral wall of the aorta (approximately 13mm).No obvious inferior vena cava stenosis was noted.Therefore, the investigation is confirmed for the alleged filter tilt and 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 in conjunction with abdominal surgery with history of pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted and struts perforated beyond inferior vena cava margins.The device has not been removed and there were no reported attempts made to retrieve the filter.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: 12126890
• MDR Text Key: 260214977
• Report Number: 2020394-2021-80539
• 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 Age: 39 YR
• Patient Weight: 128