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

Catalog Number MD800J

Device Problem Occlusion Within Device (1423)

Patient Problem Pulmonary Embolism (1498)

Event Date 03/25/2016

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: the patient with a history of morbid obesity and deep venous thrombosis (dvt) had a vena cava filter deployed at the l2-l3 level in satisfactory location and orientation.Approximately four years later, the patient presented to the hospital with chest and abdominal pain.A ct angiogram of chest/abdomen/pelvis revealed multiple right-sided pulmonary emboli, and the filter with clot around it and a large thrombus to the left iliac vein.Additionally, a large retroperitoneal hematoma within the pelvis and layering through the bilateral paracolic gutters was noted; unable to exclude underlying mass or venous source of hemorrhage.No further information is noted regarding the patient¿s current status.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided for review.Approximately four years post filter deployment, a ct angiogram revealed multiple right-sided pulmonary emboli, and ivc filter with clot around it and large thrombus to the left iliac vein.Therefore, based on the medical records, it can be confirmed the patient experienced pe after filter implantation.However, the origin of the pe and relationship to the filter have not been determined in the provided medical records.The investigation is inconclusive for the alleged occlusion within the filter, as the medical records only indicate clot around the filter at time of ct angiogram.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: acute or recurrent pulmonary embolism.This has been reported despite filter usage.It is not known if thrombi passed through the filter, or originated from superior or collateral vessels.Caval thrombosis/occlusion.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 conjunction with or before a bariatric procedure.Some time post filter deployment, the filter was allegedly occluded and the patient experienced a pulmonary embolism.Patient status was not reported.

• Brand Name: MERIDIAN 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: 7138758
• MDR Text Key: 95512325
• Report Number: 2020394-2017-01786
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102511
• 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: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• 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: FLEXERIL, MIRAPEX, NYSTATIN, TRAMADOL, TRAZADONE
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 53 YR