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

Model Number DL900J

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 05/24/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only event reported to date for this lot number and failure mode.Medical records review: the patient with history of ulcerative colitis and deep vein thrombosis had a retrievable inferior vena cava (ivc) filter deployed in the infrarenal ivc.Approximately four days post filter deployment, the patient was admitted to the hospital with complaint of leg pain.A diagnostic venogram was performed which demonstrated nonocclusive thrombus throughout the right thigh with occlusive thrombus in the right common femoral vein and iliac vein as well as the ivc.There was an extension of thrombus beyond the filter for approximately 4 cm but the thrombus appeared to be below the renal veins with patency of the ivc above the renal veins.Mechanical thrombolysis and pharmacomechanical thrombolysis were performed.Completion venogram demonstrated a thrombosed common iliac vein and ivc.An infusion catheter was place and a thrombolytic infusion was initiated.Approximately ten hours post tpa infusion, venogram demonstrated clearing of the thrombus within the common iliac and in the ivc with the exception of occlusive thrombus directly at the level of the filter.Following an embolectomy procedure, a venogram demonstrated persistent occlusion of the filter with thrombus in it.Therefore, a 4mm x 10 cm balloon was placed at two separate locations through two separate struts of the filter, and several passes were made with suction which removed fibrin and thrombus.Final venogram demonstrated a manageable amount of thrombus within the filter with no thrombus above the filter and flow re-establishment.Approximately one year one months post filter deployment, ct of the abdomen and pelvis demonstrated no evidence of ivc filter thrombosis.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the medical records, the investigation can be confirmed for occlusion of the filter as well as thrombus above the filter.Based upon 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: 03/2017; 03/2014.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 vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, occlusion was identified.The filter was not removed and there were no reported filter retrieval attempts performed.The current status of the patient is unknown.

• Brand Name: DENALLI JUGULAR SYSTEM
• 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: 7528130
• MDR Text Key: 108721273
• Report Number: 2020394-2018-00695
• 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: Attorney
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFYB3276
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2018
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 79