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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 Migration or Expulsion of Device (1395); Difficult to Remove (1528); Obstruction of Flow (2423); Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Pain (1994)
Event Date 05/28/2013
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 four months later, an attempt was made to retrieve the filter from the patient¿s body. The right internal jugular vein was punctured under ultrasound guidance, using a mini stick needle. We used a kumpe catheter to position a 15 j-wire in the upper portion of the inferior vena cava. There was some difficulty while traversing the vena cava through the filter. Then, the kumpe catheter was repositioned in the vena cava within the filter. The physicians were unable to advance it inferiorly. A venogram demonstrated a moderate sized filling defect with partial restriction of flow within the filter. The material was fibrotic, consistent with chronic clot. The filter was left in place. At this point, the procedure was completed, pulled the sheath and obtained hemostasis with manual pressure. After three months and three weeks, the patient reportedly experienced pains at knee, hip and back. After three months and three weeks, the patient presented to assess clot prior to inferior vena cava filter removal. On the same day, a magnetic resonance imaging (mri) abdomen demonstrated that an infra renal inferior vena cava filter was seen. After three months and three weeks, axial images using computed tomography angiography (cta) abdomen and pelvis without and with intravenous contrast showed no clot burden was present in the infra-inferior vena cava filter component of the cava or iliac veins. Above the filter, the cava was unremarkable. The bilateral common and external iliac veins were markedly diminutive as in the cava below the level of the inferior vena cava filter. This appeared to be chronic bilateral common and external iliac vein effective occlusion with diminution of the inferior component of the inferior vena cava. After three years and five months, a computed tomography (ct) abdomen without intravenous contrast showed that there was a bard recovery type inferior vena cava filter in place. The upper aspect of the filter crossed the confluence of the renal veins and inferior vena cava and might be slightly high in position. The filter was oriented along the axis of the infra renal inferior vena cava and tilted approximately 15-degrees towards the right with respect to the spine. The infra renal inferior vena cava was smaller in caliber, relative to the proximal inferior vena cava. The left posterior strut of the filter projected outside of the inferior vena cava wall, close to the anterior margin of the l3 - l4 disc. Several additional anterior struts projected 2 - 3 mm outside of the inferior vena cava wall, but did not extend to adjacent structures. There was no evidence for broken metallic fragment. Therefore, the investigation is confirmed for the alleged filter migration, perforation of the inferior vena cava, filter occlusion and retrieval difficulties. However, the investigation is inconclusive for the alleged filter tilt. 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 and in conjunction with or before orthopedic procedure. At some time post filter deployment, it was alleged that the filter tilted, migrated, and strut perforated the mesentery and projects outside inferior vena cava wall close to l3-l4 disc. The device has not been removed after an attempted but unsuccessful percutaneous removal procedure. The patient reportedly experienced back pain; however, 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 Key12057334
MDR Text Key258044713
Report Number2020394-2021-80518
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK093659
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 06/24/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received06/08/2021
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: 06/24/2021 Patient Sequence Number: 1
Treatment
BUPROPION HYDROCHLORIDE, OMEPRAZOLE AND ATENOLOL; CLONIDINE HYDROCHLORIDE; LOVENOX, COUMADIN AND METHADONE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
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