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 Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 05/17/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five months of post deployment, filter retrieval attempt was performed.Ultrasound guidance was utilized, and the right jugular vein was cannulated.A 5- french sheath was used following micro catheter puncture.Two separate guide wires used with placement of a diagnostic catheter to the level of the proximal right common iliac vein.Two separate views were performed that include an anteroposterior and oblique view of the cava.Note was made of an approximate 70% angulation of the caval filter within the cava.The filter limbs were away from any renal venous inflow.Several views suggested the legs extended outside the caval wall.Due to the position of the filter, attempt for its removal was not made percutaneously.The cava was patent otherwise.Filter retrieval could not be performed.Around six years and nine months later, computed tomography of abdomen without contrast was performed, and result showed that there was an inferior vena cava filter located about 2.5 cm proximal to the left renal vein.The filter showed abnormal horizontal orientation.The hub of the filter was seen abutted the rightward aspect of the inferior vena cava.The struts were seen penetrated the wall of the inferior vena cava.Four struts were seen extended to the level of the aorta.2 were seen along the anterior aspect and other 2 were seen along the dorsal aspect with no evidence of perforation.One strut was seen abutted the dorsal aspect of the duodenal sweep with no discrete perforation.The other struts were seen in the retroperitoneal space.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc), filter tilt and retrieval difficulties.Per medical records, an attempt was made to engage the apex of the filter but was unsuccessful due to filter tilt and perforation of inferior vena cava (ivc).This could have contributed to the retrieval difficulties.However, 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: 04/2014).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter tilted and struts perforated.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.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: 12105782
• MDR Text Key: 259588819
• Report Number: 2020394-2021-80533
• 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: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: GFVD1894
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2011
• 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, PERCOCET, METFORMIN; FLINTSTONE, CALCIUM, AND ALBUTEROL; LISINOPRIL, VENTOLIN INHALER, PEPCID
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 204