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

Catalog Number MD800F

Device Problem Extrusion (2934)

Patient Problems Abdominal Pain (1685); Thrombus (2101)

Event Date 07/17/2014

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: patient with renal cell carcinoma and stable nonocclusive thrombus within the inferior vena cava (ivc) and right common iliac vein had a vena cava filter successfully deployed prior to a left partial nephrectomy.Approximately two years and five months post filter deployment, the patient presented with lower abdominal pain, and was noted to not have been taken anticoagulation in over a year.Computed tomography of abdomen/pelvis showed ivc thrombosis extending from the level of the left common iliac vein through the filter approximately 1.5 cm superiorly, as well as into the proximal left renal vein.The patient was admitted and started on anticoagulation.Balloon angioplasty and thrombectomy of the ivc was performed followed by removal of the filter.The patient remained hemodynamically stable throughout the procedure and was discharged on hospital day 12.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Approximately two years and five months post filter deployment, computed tomography of abdomen/pelvis showed ivc thrombosis extending from the level of the left common iliac vein through the filter approximately 1.5 cm superiorly as well as into the proximal left renal vein.Therefore, based on the medical records, the investigation is inconclusive for the alleged perforation of the ivc as no objective evidence has been provided to confirm any alleged deficiency with the filter.However, thrombosis above the filter after implantation can be confirmed.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: precautions: procedures or activities that lead to changes in intra-abdominal.Pressure could affect the integrity or stability of the filter.Potential complications: perforation or other acute or chronic damage of the ivc wall.Deep vein thrombosis.Caval thrombosis/occlusion.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 with ovarian vein thrombosis.At some time post filter deployment, filter limb(s) allegedly extended beyond the confines of the caval wall.The filter was retrieved percutaneously.The current patient status is unknown.

• Brand Name: MERIDIAN FILTER SYSTEM - FEMORAL
• 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: 7287464
• MDR Text Key: 100644709
• Report Number: 2020394-2018-00132
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112497
• 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 Catalogue Number: MD800F
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR