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

Model Number DL900F

Device Problems Malposition of Device (2616); Extrusion (2934)

Patient Problems Pain (1994); Great Vessel Perforation (2152); Blood Loss (2597)

Event Date 12/03/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Medical records review: a vena cava filter was placed at the level of the circumaortic left renal vein due to acute deep venous thrombosis of the common and external iliac venous system with thrombosis extending into the inferior cava.Patient also had tpa catheter and stent placed with institution of thrombolytic therapy.Three days post filter deployment, the thrombus had significantly decreased.Three days later, patient developed fever and syncope.Ct of the abdomen/pelvis showed a strut of the ivc filter extending beyond the vena cava wall and a moderate retroperitoneal and extraperitoneal hemorrhage and hematoma between the right external iliac artery and vein.Eight days post filter deployment, the patient underwent successful vena cava filter retrieval.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Upon deployment, the filter was noted to have a minimal deviation toward the left side.Approximately one week post filter deployment, ct of the abdomen/pelvis showed a strut of the ivc filter extending beyond the vena cava wall and a moderate retroperitoneal and extraperitoneal hemorrhage and hematoma between the right external iliac artery and vein.Therefore, based on the provided medical records, the investigation is confirmed for the alleged filter tilt and perforation of the ivc wall.Per the provided medical records, the filter was noted to have a slight deviation to the left upon deployment.This could have contributed to the identified filter tilt.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Perforation or other acute or chronic damage of the ivc wall.Filter tilt.Filter malposition.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.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, it was alleged that the filter perforated, tilted, and embedded in the wall of the ivc.The patient reportedly experienced pain, weakness, fainting, and blood loss due to the filter, and received a blood transfusion.The current status of the patient is unknown.

• Brand Name: DENALI FILTER 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: 7285707
• MDR Text Key: 100555197
• Report Number: 2020394-2018-00129
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• 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: company representative,consum
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2018
• 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
• Treatment: FLONASE, MINOCYCLINE; TORADOL, MORPHINE, OXYCODONE, TYLENOL; YAZ, LOVENOX, WARFARIN, FAMOTIDINE, ROCEPHIN
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 17 YR
• Patient Weight: 60