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

Catalog Number RF310F

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Thrombus (2101)

Event Date 03/09/2009

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.Approximately seven months later, computed tomography of the abdomen and pelvis revealed the filter was in good position although several filter legs were protruded outside of the lumen of the inferior vena cava with clot on it and below it.Poor protruded into the lumbar vein.The patient reportedly experienced persistent abdominal pain.After one month, right jugular vein was punctured with a micro-puncture set successfully.A straight flush catheter was placed into the left iliac vein.Venography showed no thrombus within the filter.Consequently, the catheter was exchanged for the cone recovery device and the filter retrieved without difficulty.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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 prophylaxis.Approximately eight years and five months later, post filter deployment, it was alleged that the filter struts perforated.The device has been removed percutaneously.The patient reportedly experienced abdominal pain and thrombus above the filter.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: 11099789
• MDR Text Key: 224526745
• Report Number: 2020394-2020-06517
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• 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: 12/07/2020
• 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: ALBUTEROL, ALPRAZOLAM, AMBIEN, DETROL; LASIX AND MULTIVITAMIN; VYTORIN, FLEXERIL, LORTAB, COUMADIN
• Patient Outcome(s): Other
• Patient Age: 36 YR