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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); Detachment of Device or Device Component (2907); Extrusion (2934)
Patient Problems Abdominal Pain (1685); Vomiting (2144); Great Vessel Perforation (2152)
Event Date 12/29/2014
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only event reported to date for this lot number and failure mode. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: the patient with history of head trauma was scheduled for vena cava filter placement. The right common femoral vein was accessed and a flush catheter was advanced. A cavagram was performed which identified the renal veins and demonstrated no filling defects within the inferior vena cava. A filter was deployed below the renal veins. The sheath was removed and manual compression was held on the right groin until hemostasis was achieved. Approximately two years six months post filter deployment, the patient presented to the emergency department with complaint of vomiting, back pain and abdominal pain. Ct scan of the abdomen and pelvis demonstrated a tilted filter with several limbs extending beyond the caval wall into the surrounding soft tissue. A detached filter limb was identified in the right psoas muscle. It was thought that the filter perforation could be the cause of back pain and abdominal pain. A follow up ct scan with contrast was recommended to assess for perforation of any vascular structures. The patient was discharged from the hospital in stable condition and was contacted to schedule elective removal of the vena cava filter. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the device was not returned for evaluation. Images were not provided for review. Medical records were provided and reviewed. Approximately two years six months post filter deployment, ct scan of the abdomen and pelvis demonstrated a tilted filter with several limbs extending beyond the caval wall into the surrounding soft tissue. A detached filter limb was identified in the right psoas muscle. Based on the provided medical records, the investigation is confirmed for a tilted filter, perforation of the ivc wall, and a detached filter limb. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - filter fractures are a known complication of vena cava filters. - movement, migration or tilt of the filter are known complications of vena cava filters. - perforation or other acute or chronic damage of the ivc wall. - filter tilt. - filter malposition. Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. (b)(4). The information provided by bard 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 bard.

 
Event Description

It was reported that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided. No alleged deficiency with the device was reported. No other information regarding this event was received. Patient status was not provided. New information received: medical records were received and reviewed. The patient with history of head trauma had a vena cava filter successfully deployed. Approximately two years six months post filter deployment, the patient presented to the emergency department with complaint of vomiting, back pain and abdominal pain. Ct scan demonstrated a tilted filter with multiple limbs extending beyond the caval wall into surrounding soft tissue and a detached filter limb in the right psoas muscle. The patient was discharged in stable condition and was advised to schedule elective removal of the vena cava filter. No additional information was provided in the medical records received.

 
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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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6504475
MDR Text Key73220827
Report Number2020394-2017-00347
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 ATTORNEY
Type of Report Initial
Report Date 04/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/19/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2015
Device Catalogue NumberEC500F
Device LOT NumberGFWC1091
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/20/2012
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: 04/19/2017 Patient Sequence Number: 1
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