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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 Complete Blockage (1094); Occlusion Within Device (1423); Difficult to Remove (1528); Material Deformation (2976)
Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2015
Event Type  malfunction  
Manufacturer Narrative
No device, no medical records or no medical images have been made available to the manufacturer. As the lot number for the device has not been provided, a review of the device history records could not be performed. The investigation of the reported event is currently underway.
 
Event Description
It was reported that approximately 18 months post vena cava filter deployment, during a scheduled filter retrieval, ivc occlusion was discovered at the level of the filter. No attempts were made to retrieve the filter. No other pertinent medical information was provided surrounding the events. Current patient status is unknown.
 
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: as medical records were not provided, a review could not be performed. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the investigation is inconclusive for an occluded ivc at the level of the filter. Based upon the available information, the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: warnings: 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. Potential complications: caval thrombosis/occlusion 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.
 
Manufacturer Narrative
Medical records review: the patient had a prophylactic inferior vena cava filter placed for prolonged immobility and intracranial hemorrhage. The right groin was prepped and draped in usual sterile fashion. The right common femoral vein was accessed and the filter was successfully deployed in an infrarenal location. The patient tolerated the procedure well without immediate complication. Conclusion: the device was not returned. Images were not received. Medical records were provided. The medical records allege a vena cava filter was implanted successfully in an infrarenal location via the right common femoral vein. No deficiencies were reported within the medical records. The investigation is inconclusive for the reported event. Based upon the available information, the definitive root cause for this event is unknown. (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
New information received - it was reported by the patient a vena cava filter was deployed in conjunction with a trauma situation/motor vehicle accident. After an unknown amount of time post filter deployment, an unsuccessful percutaneous filter retrieval attempt was performed. Based on medical records received from the patient, it was identified a vena cava filter was deployed successfully for dvt prophylaxis. The patient tolerated the procedure well. No additional information was received in the medical records provided.
 
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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 Key5478498
MDR Text Key39854544
Report Number2020394-2016-00237
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,Followup,Followup,Followup
Report Date 11/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberMD800F
Device Lot NumberGFXF3382
Was Device Available for Evaluation? No
Date Manufacturer Received11/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/26/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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