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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. DENALI FEMORAL SYSTEM VENA CAVA FILTER Back to Search Results
Model Number DL900F
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)
Patient Problem Hematoma (1884)
Event Date 06/14/2016
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a lot history review was performed. This is the only complaint to date for this lot number. Therefore, a device history record review is not required. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Approximately twenty five days later, the patient presented for filter removal via jugular vein access. Computed radiography abdomen single view revealed the filter was in horizontal orientation at intravertebral disc space. The filter was completely penetrated the vena cava and the filter cap as well as the legs were exposed outside the cava. The filter was completely in a transverse position and was not amendable to percutaneous retrieval. Numerous attempts were made to engage the filter hook with a snare were unsuccessful. After straightening the filter, attempts at snare the hook was pursued. Unfortunately, these attempts were unsuccessful to engage the filter hook. The filter unfortunately become malpositioned and took a more horizontal position. Contrast injection in the inferior vena cava suggested the hook of the filter to be outside of the inferior vena cava. Several tiny filling defects were noted adjacent to the filter, so heparin was administered. Fluoroscopic imaging over the chest failed to demonstrate any radiopaque tines within the chest. After failed attempts the snare was engaged with one of the struts. The right common femoral vein was accessed with a micro-puncture needle and snare was able to be freed. After multiple attempts the filter retrieval was unsuccessful and the filter had taken a nearly horizontal position. The filter hook appeared to be strongly adherent to the right lateral wall of the inferior vena cava, and the filter could not be freed from the lateral wall and these efforts increased the filter tilt. The filter fragment was intact and did not dislodge during manipulation. More aggressive attempts at dislodging the filter hook from the inferior vena cava would have put the patient at risk for inferior vena cava injury and the procedure was terminated. Twenty six days later, computed tomography of the abdomen and pelvis with contrast revealed the filter was horizontally oriented in the inferior just below the insertion of the renal veins near the insertion of the right ovarian vein. The filter prongs appeared to be extended outside of the inferior vena cava walls with a surrounding fat stranding. The prominence appeared to abut the right lateral wall of the aorta. Twenty seven days post filter deployment, the patient presented for open retrieval. Incision was made from the epigastrium just below the umbilicus. Upon dissection of the left lateral surface of the cava, the filter legs were encountered and at least four penetrated legs that were accessible from the outside. The legs were then sharply cut flush to the cava utilizing the wire cutters. Filter hook was dislodged into the origin of the ovarian vein and penetrated through ovarian vein into the retroperitoneum. There was a small amount of hematoma, but there was no active extravasation. A silk stitch was tied to the filter hook and completely able to ensheath the filter and successfully removed. The patient still had a large amount of residual thrombus within the cava and risk for pulmonary embolus, hence open cavotomy was performed and recovered large amount of organized thrombus as well as fresh thrombus. Therefore, the investigation is confirmed filter tilt, retrieval difficulties and perforation of the inferior vena cava (ivc). However the investigation is inconclusive for filter migration. 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. (expiry date: 03/2019), (b)(4).

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism. At some time post filter deployment, it was alleged that the filter tilted, migrated to the ovarian vein and struts perforated the retroperitoneum. The device was removed via open chest procedure after an attempted but unsuccessful removal procedure. It was further reported that the hook of the filter dislodged in the ovarian vein with pericaval hematoma. The current status of the patient is unknown.

 
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Brand NameDENALI FEMORAL 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 Key10337024
MDR Text Key200754763
Report Number2020394-2020-05201
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK130366
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 07/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/29/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberDL900F
Device Catalogue NumberDL900F
Device LOT NumberGFAQ1143
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2020
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: 07/29/2020 Patient Sequence Number: 1
Treatment
LOVENOX
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