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

Model Number DL900J

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Medical record review: an inferior vena cava filter was deployed secondary to anticipated surgery for adenocarcinoma of the stomach.The deployed filter was placed infrarenal via the right internal jugular.Inferior venacavogram performed during filter deployment revealed the filter deployed caudally, filter apex at l3 superior endplate, filter legs at the level of the cava confluence.An amplatz gooseneck snare was used to reposition the filter.Filter was recaptured into the sheath then filter was redeployed with the apex at the l2 pedicle.Venacavagram revealed appropriate filter position, the apex below the renals.Approximately six months post deployment venous doppler performed, revealed chronic nonocclusive right popliteal deep venous thrombosis, no evidence of acute dvt.Approximately one month later patient presented for ivc filter retrieval.Venacavogram revealed a widely patent cava, no filter thrombus.Multiple retrieval attempts with ampiatz snare, ensnare and glidewire were unsuccessful due to the posterior positioning and tilt of the apical hook.Post cavagram revealed a secondary strut extending horizontally into the ivc secondary to multiple attempts using loop snare technique.Unsuccessful optional ivc filer retrieval secondary to posterior tilt with extravasation positioning of the apical hook.Filter position unchanged.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Post deployment, an amplatz gooseneck snare was used to reposition the filter.The filter was recaptured into the sheath then filter was redeployed with the apex at the l2 pedicle.Approximately seven months post deployment, multiple retrieval attempts were unsuccessful with ampiatz snare, ensnare, and glidewire.Due to the tilt of the apical hook.Post cavagram revealed a secondary strut extending horizontally into the ivc, and additionally, revealed posterior tilt with extravascular positioning of the filter hook.Therefore, the investigation is confirmed for misplaced filter, retrieval difficulties, filter tilt, perforation, and material deformation.Per the provided medical records, the filter was recaptured and redeployed.Per the current ifu (instructions for use), "do not deploy the filter prior to proper positioning in the ivc, as the denali vena cava filter cannot be safely reloaded into the storage tube.Do not deploy the filter unless ivc has been properly measured.Never re-deploy a removed filter." therefore, the redeployed filter could have contributed to any of the alleged deficiencies.Additionally, a strut was revealed extending horizontally into the ivc secondary to multiple retrieval attempts using loop snare technique.It is likely that the retrieval attempts caused the limb deformation.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings: do not deploy the filter prior to proper positioning in the ivc, as the denali® vena cava filter cannot be safely reloaded into the storage tube.Do not deploy the filter unless ivc has been properly measured.Never re-deploy a removed filter.Precautions: if misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal.Do not attempt to reposition the filter.Abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter.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.(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

It was reported through the litigation process that a inferior vena cava filter was placed in a patient for prophylaxis prior to surgery on stomach.At some time post filter deployment, it was alleged that the ivc filter was irretrievable due to filter tilting and was embedded in the ivc.The device was not removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: DENALI FILTER SYSTEM - JUGULAR
• Type of Device: VENA 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 Key: 7895855
• MDR Text Key: 120978834
• Report Number: 2020394-2018-01752
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2018
• 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 Sequence Number: 1
• Patient Age: 59 YR