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

Catalog Number RF310F

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Thrombosis (2100)

Event Date 05/22/2010

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 three years and ten months post filter deployment, computed tomography (ct) revealed the inferior vena cava filter was in place.After two days later, computed tomography (ct) revealed the inferior vena cava filter was in place and the filter apex projected about 4 cm above the level of the right venal vein.There was thrombosis of the inferior vena cava at and below the level of the filter.Thrombus was also noted within both internal iliac veins as well as within the superficial femoral and profunda femoral veins.After two days later bilateral lower extremity venogram, bilateral lytic catheter placement and balloon angioplasty, right superficial femoral were done.After one day later lytic check venogram and repositioning of lytic catheter were performed and the clot in the inferior vena cava was resolved.On the same day, a recovery cone was inserted and used to capture the filter which was removed without difficulty.The option filter was placed at the level of the right renal vein.Therefore, the investigation is inconclusive for filter migration.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/pulmonary embolism.At some time post filter deployment, it was alleged that filter migrated to the inferior vena cava.The device was removed percutaneously.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: 10217270
• MDR Text Key: 197098579
• Report Number: 2020394-2020-04180
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• 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: GFPK1184
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/09/2020
• 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, DARVOCET, METHOTREXATE; CLARITIN, MULTIVITAMIN, PROTONIX; DYAZIDE, ATARAX, LISINOPRIL; LOVENOX, ELAVIL, COUMADIN; SIMVASTATIN
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 82