MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF310F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/22/2009

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: the patient with history of recurrent pulmonary emboli was scheduled for inferior vena cava filter placement.The right common femoral vein was accessed and the filter was successfully deployed at the l2-l3 location.The patient was hemodynamically stable at the conclusion of the procedure.Approximately five months post filter deployment, an inferior vena cavogram demonstrated a patent inferior vena cava with the filter in a tilted position.Approximately six months post filter deployment, the patient was scheduled for filter retrieval.The right internal jugular vein was accessed and multiple unsuccessful attempts were made in an attempt to retrieve the tilted filter.One filter limb became dislodged, by a fish hook on the retrieval device, but all other limbs of the filter were fine.After approximately one hour, the procedure was concluded and the filter remained in place.All retrieval devices were removed and the patient was hemodynamically stable at the conclusion of the procedure.Image/photo review: as medical images were not provided, a review could not be performed.Conclusion: the device was not returned.Images were not provided.Medical records were provided.A vena cava filter was successfully deployed.Five months post filter deployment, a vena cavogram identified the filter to be in a tilted position.Six months post filter deployment, multiple attempts were made to remove the filter however the filter remained implanted.Based on the medical records, the investigation can be confirmed for a tilted filter and difficulties removing the filter.The filter likely could not be retrieved because the filter was tilted against the ivc wall.However, the definitive root cause for the event is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.Possible complications include, but are not limited to, the following: - movement, migration or tilt of the filter are known complications of vena cava filters.- filter tilt - filter malposition.Precautions: - procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter.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

Medical records were received and reviewed.Approximately five months post filter deployment, inferior vena cavogram demonstrated a patent inferior vena cava with the filter in a tilted position.The patient was scheduled for a filter retrieval procedure approximately six months post filter deployment.The right internal jugular vein was accessed and multiple unsuccessful attempts were made to retrieve the filter.The patient was hemodynamically stable at the conclusion of the procedure.No additional information was provided in the medical records received.

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.Approximately five months post filter deployment, inferior vena cavogram demonstrated a patent inferior vena cava with the filter in a tilted position.The patient was scheduled for a filter retrieval procedure approximately six months post filter deployment.The right internal jugular vein was accessed and multiple unsuccessful attempts were made to retrieve the filter.After some times from post filter deployment, it was alleged that detached and tilted.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five months later post filter deployment, an inferior vena cavogram was performed which showed prior placement of filter which was noted within the inferior vena cava at the l3-l4 interspace level.No caval thrombosis or entrapped thrombus within the inferior vena cava filter.After two weeks, patient was planned for filter retrieval procedure.Through the right internal jugular vein approach, a guidewire was passed followed by sheath.A diagnostic catheter to get the wire down into the inferior vena cava down near and through the filter itself.Through the sheath, a g2 retrieval device was advanced and carefully opened its cone below the tip of the sheath and tried to grasp the head of the inferior vena cava filter.Despite multiple attempts, the procedure was unsuccessful.Again, advanced the retrieval device but unable to grab the tip of the filter and retrieve it.At one point one of the legs of the filter was dislodged by one of the fishhooks on the retrieval device but otherwise all of the other legs on the filter were fine.At this point, after an effort to retrieve the filter and decided to stop the procedure.After nine years and ten months, a computed tomography of abdomen was performed for inferior vena cava injury.The study showed that the filter apex begins 5.1 cm below the lowest left renal vein.The apex of the filter was tilted anteriorly against the anterior inferior vena cava wall.Apex tip protrudes into and possibly slightly through the anterior inferior vena cava wall seen on sagittal image.The inferior struts all perforate through the inferior vena cava wall into adjacent periaortic fat and one strut traverses or at least contacts the posterior margin in the aorta.The inferior struts terminate 1 cm above the iliac bifurcation.Therefore, the investigation is confirmed for the alleged filter tilt, perforation of the inferior vena cava, filter limb detachment, filter migration and retrieval difficulties.Based on the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: b5, b6, g3, h6(device).H11: g1, h6(method, conclusion).H11:section a through f - the information provided by bd 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 bd.

• Brand Name: G2 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6135877
• MDR Text Key: 61151965
• Report Number: 2020394-2016-01122
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/04/2022
• 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: COUMADIN; COUMADIN; COUMADIN
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 101 KG