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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI VENA CAVA FILTER Back to Search Results
Catalog Number UNK DENALI
Device Problems Occlusion Within Device (1423); No Flow (2991); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Pain (1994); Swelling (2091); Thrombosis (2100); Thrombus (2101)
Event Date 05/30/2015
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 two days after ivc filter placement to treat dvt in the right leg, the patient experienced an increase in the severity of the dvt including multiple pe. The patient further alleges that new clots started at the ivc filter and spread down both legs. The patient then alleges that they spent 14 days in icu and during that time 14 hours of interventional radiologic procedures were allegedly required to restore blood flow to the legs. The patient also alleges that there is ongoing swelling in their calves and pain.
 
Manufacturer Narrative
Manufacturing review: a lot history review was not performed as the lot number was not provided. Visual/microscopic inspection: a visual and microscopic inspection could not be performed as the device was not returned. Functional/performance evaluation: a functional and performance evaluation could not be performed as the device was not returned. Medical records review image/photo review: medical records were not provided. No images or photos were provided. Conclusion: the investigation is inconclusive for the reported event. Based upon the available information, the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessels. Deep vein thrombosis, pain. (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.
 
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Brand NameDENALI VENA 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
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5695943
MDR Text Key46468822
Report Number2020394-2016-00510
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 05/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received07/01/2016
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: 06/02/2016 Patient Sequence Number: 1
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