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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 01/09/2010

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one year and two months post filter deployment, the patient presented with left lower quadrant pain and known left renal atrophy.Subsequently on the same day, computed tomography (ct) revealed that there was an inferior vena cava filter seen lying in an abnormal transverse orientation below the right renal vein.At least 1 of the filter legs appeared to have penetrated through the inferior vena cava wall.Therefore, the investigation is confirmed for malposition of the inferior vena cava (ivc) filter.However, the investigation is inconclusive for the alleged perforation of the perforation of the inferior vena cava (ivc) because based on the medical record provided, at least 1 of the filter legs appeared to have penetrated through the inferior vena cava wall.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.(expiry date: 08/2011).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with right leg deep venous thrombosis and recent brain surgery/transsphenoidal hypophysectomy.Approximately one year and two months post filter deployment, a computed tomography (ct) abdomen and pelvis without intravenous contrast revealed that the filter lay in a transverse orientation and perforated the vena cava.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly experienced left lower quadrant 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: 11250479
• MDR Text Key: 229324629
• Report Number: 2020394-2021-80139
• 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: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• 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: GFSG4584
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• 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: 57 YR