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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
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. After sometimes post deployment, a computed tomography of abdomen and pelvis was performed which showed positive for perforation and tilt. Inferior vena cava filter was at the superior l2 to inferior l3 level. Migration unlikely but unable to fully evaluate. Significant ventral tilt with coronal 11 degrees to left and sagittal 26 degrees ventral. Grade iii perforation was noted with left lateral strut abuts aorta (11 mm), posterior strut abuts l3 (11 mm), and ventral strut abuts duodenum (9 mm). After six months, a computed tomography of abdomen and pelvis was performed for filter evaluation. The study showed that inferior vena cava filter was noted. No filter tilt, migration and fracture were identified. There was a perforation of the struts of the inferior vena cava filter beyond the wall of the inferior vena cava. This includes a medially oriented strut which appears to perforate into the aorta. Two anteriorly oriented struts touch the posterior serosal layer of the small bowel. The remainder of the struts perforate into the retroperitoneal space. There were no findings of inferior vena cava stenosis. After one year and four months, patient presented to the emergency department with the complaints of abdominal pain. After two days, a computed tomography of abdomen and pelvis was performed which showed 2 cm radiopaque density adjacent to the small bowel and transverse colon of the anterior abdomen, could represent extraluminal wire bristle. 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 after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, it was alleged that the filter strut perforated. 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 NameVENA CAVA FILTER
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 Key12056322
MDR Text Key258023746
Report Number2020394-2021-80517
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
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 NumberUNKNOWN FILTER
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
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