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

Catalog Number RF310F

Device Problems Positioning Problem (3009); Patient Device Interaction Problem (4001); Migration (4003)

Patient Problem Abdominal Pain (1685)

Event Date 09/13/2010

Event Type  Injury  

Manufacturer Narrative

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.The medical records allege bard g2 filter was implanted in the l3 level location for a patient.Unfortunately, the filter immediately turned sideways, and the deployment wire appeared to catch one of the legs of the filter.The filter was deployed at l3 level but appeared to migrate up in interspace up around the l2 region after attempt to dislodge the delivery system from the filter.The filter remained in a sideways position and appeared to be lodged at the area of the right renal vein and well below the left renal vein.The filter appears to be located horizontally.After two days, dx abdomen one view revealed the filter was oriented in transverse manner.Radiographic impression revealed the filter was transverse orientation at the l1-l2 level.After five months, through the right femoral vein access, a bard eclipse filter was successfully deployed just below the previously placed filter at l3 level for a patient.On the same day, inferior vena cava x-ray revealed the first filter tip was pointed inferiorly and to the left.It was obliquely positioned in relation to the inferior vena cava.Injection of the inferior vena cava reveals some of the tines of the filter had superior to the inferior vena cava.There was no clot within the filter.Some of the filter tines pierced the inferior vena cava.The more cephalad filter had some of the struts projected within the right renal vein.The second filter appears to be properly oriented.The patient experienced abdominal pain.Therefore, the investigation is confirmed for the alleged positioning issue, filter migration and perforation of the inferior vena cava.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.

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, and pulmonary embolism.During deployment, it was alleged that the filter tilted and migrated.At some time post filter deployment, it was alleged that the struts perforated.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced abdominal pain; however, the current status of the patient is unknown.

• 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: 12073453
• MDR Text Key: 258633578
• Report Number: 2020394-2021-80529
• 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
• Report Date: 06/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: Yes
• 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: 06/08/2021
• 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
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 144