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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number UNK DENALI
Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  Injury  
Manufacturer Narrative
No device, no medical records, or no medical images were provided to the manufacturer. The lot number for the device was not provided; therefore, a review of the device history records could not be performed. The investigation of the reported event is currently underway. 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 during deployment of a vena cava filter, the filter allegedly did not expand and migrated to the heart. Reportedly, multiple attempts were made to retrieve the filter but were unsuccessful. The patient was moved to the ccu and hospitalized for observation.
 
Manufacturer Narrative
Manufacturing review: a manufacturing review was not performed as the lot number was not provided. Visual inspection and functional/performance evaluation: the device was not returned; therefore, no visual inspection or functional testing of the device was performed. Medical records review: medical records were not provided for review. Image/photo review: images/photos were not provided for review. Conclusion: the device was not returned. Images and medical records were not provided. The investigation was inconclusive for failure of the filter to expand and migration of the device. Based upon the available information, the definitive root cause was unknown. Labeling review: the current ifu (instructions for use) states: warning: delivery of the denali filter through the introducer sheath is advance only. Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath. Movement, migration or tilt are known complications of vena cava filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal migration. Migration may be caused by placement of the filter in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu. Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens. Precautions: care should be taken to ensure the connection between the introducer sheath hub and the filter storage tube is tight; however, the use of excessive force which can cause slippage of the threads and/or breakage of the hub should be avoided. Do not deliver the filter by pushing it beyond the end of the introducer sheath. To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath. Do not twist the pusher at anytime during this procedure. Potential complications: movement, migration or tilt are known complications of vena cava filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal migration. Migration may be caused by placement of the filter in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu. Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens. Failure of filter expansion/incomplete expansion. 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 during deployment of a vena cava filter, the filter allegedly did not expand and migrated to the heart. Reportedly, multiple attempts were made to retrieve the filter but were unsuccessful. The patient was moved to the ccu and hospitalized for observation.
 
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Brand NameDENALI 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key6301532
MDR Text Key66520241
Report Number2020394-2017-00039
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeJO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK DENALI
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 Received02/23/2017
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: 02/03/2017 Patient Sequence Number: 1
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