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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
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.
 
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Brand NameECLIPSE FILTER SYSTEM - FEMORAL
Type of DeviceVENA 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 Key12126890
MDR Text Key260214977
Report Number2020394-2021-80539
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 07/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberEC500F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2021
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 Treatment Data
Date Received: 07/07/2021 Patient Sequence Number: 1
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