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

Model Number 2220J

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pulmonary Embolism (1498); Chest Pain (1776)

Event Date 03/02/2014

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the lot number has been provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported for this lot number and issue to date.Medical records review: the patient with pulmonary emboli (pe), deep vein thrombosis (dvt) in the right leg, and contraindication to anticoagulation had a vena cava filter deployed just above the body of l1.Approximately eight months post filter deployment, the patient was admitted for abdominal pain with gastrointestinal bleeding secondary to diverticulitis.A lumbar spine x-ray was performed which noted the filter at the l2-l3 levels.During admission, the patient complained of shortness of breath and pleuritic chest pain.A ventilation/perfusion scan was intermediately positive for pe.A left lower extremity vascular study demonstrated chronic dvt of the left superficial femoral vein with recanalization of flow was noted with normal compression, augmentation, and respiratory variation of the remaining left lower extremity venous system.The patient was placed on anticoagulation.The status of the filter and current status of the patient is unknown.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Approximately eight months post filter deployment, a lumbar spine x-ray was performed which noted an ivc filter at the l2-l3 levels.A vq scan was intermediately positive for pe.The filter was noted to originally be deployed at the l1 level.Therefore, based on the medical records, the investigation is confirmed for migration of filter.It can also be confirmed that the patient experienced pe after filter implantation; however, the origin of the pe and the relationship to the filter was not established in the provided medical records.Based upon the available information, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: migration of the filter - this may be caused by placement in oversized venae cavae greater than 28mm, or large migrating thrombus dislodging the filter from its deployed position.Potential complications: -recurrent pulmonary embolism, this has been reported despite filter usage.It is not known if thrombus passed through the filter or via collateral means.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 deployed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the patient experienced a pulmonary embolism.The current patient status is unknown.

• Brand Name: SIMON NITINOL 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: 7131632
• MDR Text Key: 95320346
• Report Number: 2020394-2017-01778
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040917
• UDI-Public: (01)00801741040917
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970099
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: 2220J
• Device Catalogue Number: 2220J
• Device Lot Number: GFVH3772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2011
• 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; Life Threatening
• Patient Age: 60 YR