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

Catalog Number MD800F

Device Problem Malposition of Device (2616)

Patient Problem Pulmonary Embolism (1498)

Event Type  Injury  

Manufacturer Narrative

No medical images have been made available to the manufacturer.Medical records were provided and reviewed.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient with deep vein thrombosis (dvt) and bilateral pulmonary embolus (pe) had a vena cava filter deployed in an infrarenal position.A post deployment venogram was also done to confirm proper placement of the device.Approximately one year post filter deployment, the patient was found to have dvt and bilateral pe.The patient was started on an anticoagulation drip and discharged on continued anticoagulation.Approximately one year later, the patient again experienced dvt and pe.An abdominal and pelvic ct scan demonstrated the filter to be in place and a large fibroid uterus continuing to compress the ivc as well as the distal aspect of the filter.No further information is noted regarding the patient¿s current status.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 after being diagnosed with deep vein thrombosis/ pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted while embedded in the wall of the ivc.The device has not been removed and there were no reported filter removal attempts.The current patient status is unknown.

Manufacturer Narrative

A manufacturing review was performed.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 to date for this lot number and failure mode.The device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Approximately two year post filter deployment, patient was found to have bilateral pe during hospital admittance.Approximately three years post filter deployment, the patient again experienced pulmonary emboli.Ct scans performed over this period of time demonstrated the filter to be in place.Therefore, based on the provided medical records, it can be confirmed the patient experienced pe after filter implantation.However, the origin of the pe and the relationship to the filter has not been established in the medical records.Additionally, the investigation is inconclusive for the alleged filter tilt based on the provided medical records.Based upon the available information, the definitive root cause is unknown.Labeling review:the current ifu (instructions for use) states: warnings: movement, migration or tilt of the filter are known complications of vena cava filters.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.Potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.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.Filter tilt, filter malposition.

Event Description

It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted while embedded in the wall of the ivc.The device has not been removed and there were no reported filter removal attempts.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: 7150097
• MDR Text Key: 95896164
• Report Number: 2020394-2017-01820
• 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: consumer,health professional
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2015
• Device Catalogue Number: MD800F
• Device Lot Number: GFYC3757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2014
• 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