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

Catalog Number EC500J

Device Problems Difficult to Remove (1528); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2011

Event Type  malfunction  

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 pulmonary embolism had a vena cava filter deployed in an infrarenal position.Two months later, the patient was sent for filter retrieval.Venography of the inferior vena cava (ivc) demonstrated no evidence of thrombus within the ivc or within the filter; however, the filter was tilted and situated low in the ivc.Several attempts were made to advance the cone retrieval device over the filter apex unsuccessfully and the procedure was concluded.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 in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that the filter tilted and could not be retrieved during a percutaneous removal procedure.The current patient status is unknown.

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 embolism had a vena cava filter deployed in an infrarenal position.Two months later, the patient was sent for filter retrieval.Venography of the inferior vena cava (ivc) demonstrated no evidence of thrombus within the ivc or within the filter; however, the filter was tilted and situated low in the ivc.Several attempts were made to advance the cone retrieval device over the filter apex unsuccessfully and the procedure was concluded.No further information is noted regarding the patient¿s current status.Investigation summary: the device was not returned.Images were not provided for review.Medical records were provided and reviewed.Two months post filter deployment, the patient was scheduled for filter removal.Under ultrasound guidance and venography, it was noted that the filter was tilted and situated low in the ivc.Several attempts were made to advance the cone over the filter apex, unsuccessfully secondary to the marked tilt of the filter so the procedure was abandoned.Therefore, based on the provided medical records, the investigation is confirmed for a tilted filter and retrieval difficulties resulting in the filter remaining implanted.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 precautions: the safety and effectiveness of this device has not been established for morbidly obese patients.Open abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter.Procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter.Potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Filter tilt filter malposition filter tilt filter malposition.

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 tilted and could not be retrieved during a percutaneous removal procedure.The current patient status is unknown.

• Brand Name: ECLIPSE 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: 7151787
• MDR Text Key: 96129383
• Report Number: 2020394-2017-01825
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• 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,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: EC500J
• Device Lot Number: GFVD3386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2011
• 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 Age: 45 YR
• Patient Weight: 98