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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 Problem Extrusion (2934)
Patient Problem Great Vessel Perforation (2152)
Event Date 08/26/2011
Event Type  No Answer Provided  
Manufacturer Narrative
Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided. 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 a history of recurrent deep venous thrombosis (dvt), factor v leiden deficiency and pulmonary embolism was diagnosed with new onset of recurrent left lower extremity dvt despite a therapeutic anticoagulation level. Ct was performed to determine the level of the renal vein for ivc filter insertion. The right renal vein was identified to enter the cava at the level of the upper body of l1. The left renal vein was slightly lower in the mid to lower body of l1. The following day, the patient¿s right groin was prepped and draped. Using direct ultrasound guidance, the right common femoral vein was punctured with a micropuncture needle. The ivc filter delivery system was advanced and the filter was deployed with the tip in the region of the lower body of l1. A spot film was obtained confirming successful infrarenal placement. The delivery system was removed and hemostasis was achieved. Approximately two months post filter deployment, ct performed for posterior abdominal pain and evaluation for renal calculi identified the filter to be in place but with two posterior limbs extending beyond the caval wall. The report recommended reassessment of the filter. The patient was discharged the following day with a clinical diagnosis of renal colic. Approximately five months post filter deployment, a follow-up ct performed confirmed the ivc filter to be in place with no change compared to the previous study. Multiple subsequent ct exams over the next four years identified the filter to remain stable and unchanged in position. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the device was not returned. Images were not provided. Medical records were provided and reviewed. A vena filter was successfully deployed. Approximately two months post filter deployment, a ct identified the filter to be in place with two posterior limbs extending beyond the caval wall. Based on the provided medical records, the investigation can be confirmed for perforation of the ivc wall by filter limbs. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: perforation or other acute or chronic damage of the ivc wall. 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 provided. The patient status at this time is unknown. New information received: medical records were received and reviewed. Approximately two months post vena cava filter deployment for dvt despite therapeutic anticoagulation, an incidental finding on ct identified two filter limbs extending beyond the caval wall. All subsequent imaging noted the filter to be stable and unchanged in position. No additional information surrounding this event 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 Key6156819
MDR Text Key61856053
Report Number2020394-2016-01149
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 Attorney
Type of Report Initial
Report Date 02/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2016
Is this an Adverse Event Report? No
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/29/2016
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: 12/08/2016 Patient Sequence Number: 1
Treatment
COUMADIN, OMEPRAZOLE
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