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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)
Patient Problem Pulmonary Embolism (1498)
Event Date 09/12/2014
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 severe disease in the cervical spine, a history of deep venous thrombosis and contraindication to anticoagulation secondary to possible upcoming surgery, presented for placement of a vena cava filter. The left groin was prepped and draped in sterile fashion. Ultrasound guidance was used to gain access into the left common femoral vein. Utilizing modified seldinger technique, an introducer sheath system was advanced to the caudal ivc. Inferior venacavogram was performed to document patency of the ivc and location of the renal veins. Subsequently, the sheath was introduced to the appropriate mid inferior vena cava location. Using standard technique an ivc filter was successfully deployed in the ivc below the level of the renal veins. The patient tolerated the procedure without complaint or complication. Hemostasis was established in the right groin. The patient was discharged in stable and satisfactory condition. Approximately one year seven months post filter deployment, the patient was documented to have experienced pulmonary embolism and was admitted overnight. Approximately one year nine months post filter deployment, the patient returned to the hospital for new blood clots in the left leg and ivc. Two attempts to perform thrombolysis were unsuccessful due to the patient experiencing pain and dislodging the catheter. The patient was placed on anticoagulation therapy and the swelling was improving. The patient was discharged three days post admission in stable condition. Image/photo review: no images or photos 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 cava filter was successfully deployed below the renal veins. One year and seven months post filter deployment, the patient was documents to have experienced pe. One year and nine months post filter deployment, the patient had two attempts at thrombolysis however it was not identified if the clot was occluding the filter. Based on the medical records, the investigation is inconclusive for occlusion within the device. However, pe after implantation can be confirmed but the location to which it originated and the relationship to the filter is unknown. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: - caval thrombosis/occlusion 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. 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 one year seven months post vena cava filter deployment for history of dvt with contraindication to anticoagulation secondary to possible upcoming surgical procedure, the patient experienced pulmonary embolism and was admitted overnight. Approximately one year nine months post filter deployment, the patient returned to the hospital for new blood clots in the left leg and ivc. Two attempts to perform thrombolysis were unsuccessful due to the patient experiencing pain and dislodging the catheter. The patient was placed on anticoagulants which improved the leg swelling. The patient was discharged three days later in stable condition. No additional medical records were received for this patient.
 
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Brand NameMERIDIAN 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 Key6194238
MDR Text Key62967103
Report Number2020394-2016-01189
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2013
Device Catalogue NumberMD800F
Device Lot NumberGFWD2817
Was Device Available for Evaluation? No
Date Manufacturer Received02/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2013
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: 12/21/2016 Patient Sequence Number: 1
Treatment
LOVENOX
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