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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number RF048F
Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 05/12/2010
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 years of post deployment, computerized tomography-abdomen/ pelvis was performed which showed that there was an inferior vena cava filter, and some filter legs extend through the wall of the inferior vena cava, like the previous exam, without surrounding hematoma, also like the study from the previous year. Approximately six years and two months later, retrieval of the inferior vena cava filter was scheduled. Access was gained via right internal jugular vein. Multiple magnified spot views of the inferior vena cava filter were performed to evaluate for possible fracture. Over a bentson guidewire, the tract was progressively dilated until a 16 french sheath 45 cm in length was advanced into the inferior vena cava. Then, 5 french omni flush catheter was directed into the inferior vena cava followed by inferior vena cavography with co2. Then, utilizing bronchoscopy forceps, blunt dissection of the nose of the filter was performed with at incident. Then, this allowed grasping of the nose of the filter which was easily extracted through the sheath. The 5 french omni flush catheter is removed positioned in the inferior vena cava followed by repeat co2 angiography. Initial co2 cavography demonstrated a patent inferior vena cava. The nose of the filter was tilted and in contact with the right lateral wall the inferior vena cava. Co2 followed by contrast inferior vena cavography demonstrated successful removal of the inferior vena cava filter. Therefore, the investigation is confirmed for 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 or before bariatric procedure. At some time post filter deployment, it was alleged that the filter tilted and embedded in the wall of inferior vena cava. The device was removed percutaneously. The current status of the patient is unknown.
 
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Brand NameRECOVERY FILTER SYSTEM
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 Key11870316
MDR Text Key252175908
Report Number2020394-2021-80464
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031328
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 05/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF048F
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 Received04/27/2021
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: 05/24/2021 Patient Sequence Number: 1
Treatment
ATORVASTATIN, CARVEDILOL, FAMOTIDINE, FUROSEMIDE; ATROVENT, LORTAB, REGLAN, PREVACID, BENADRYL; BENZOATE, DOCUSATE SODIUM, FERROUS SULFATE; CLONIDINE, DIPHENHYDRAMINE, GABAPENTIN; CYANOCOBALAMIN, AMBIEN, NEXIUM, ALBUTEROL; METOCLOPRAMIDE, MULTIVITAMINS, MIRALAX; METOPROLOL, NIFEDIPINE, ZOLPIDEM, AMLODIPINE; PREGABALIN, PROMETHAZINE, CALCIUM CARBONATE
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