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

Catalog Number UNKNOWN G2

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 07/17/2017

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.Post filter deployment, patient presented with abdominal pain.Subsequently a computed tomography revealed an inferior vena cava filter in place.Filter tip was located 1.3 cm below the level of the lowest left renal vein.The apex of the filter was approximately 2 mm from the anterior aspect of the inferior vena cava filter wall.Multiple filter struts or limbs perforated beyond the inferior vena cava wall.The maximum length of the filter limb perforation beyond the inferior vena cava filter wall was 1.6 cm.Inferior vena cava filter limbs extended into the wall of the adjacent aorta, l3 vertebral body, duodenum, and retroperitoneum.Therefore, the investigation is confirmed for the perforation of the ivc.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 deployed successfully, the reason for the filter deployment was not provided.At some time, post filter deployment, it was alleged that the filter 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
• 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: 10319101
• MDR Text Key: 200203716
• Report Number: 2020394-2020-05084
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN G2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 46 YR