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

Catalog Number RF310F

Device Problems Malposition of Device (2616); Unintended Movement (3026); Patient Device Interaction Problem (4001)

Patient Problems Death (1802); Pain (1994); Blood Loss (2597)

Event Type  Death  

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical records were provided and reviewed.On an unspecified date, ct scan revealed that hook of the filter was at l2-l3 interspace.Also, it was observed that ivc filter was severely tilted with the hook contacting the ivc wall.All the struts were perforating the ivc wall, among which three of the anterior struts perforated the ivc wall and contacting the bowel.Later, the patient presented with gi bleeding.Ct scan revealed that the ivc filter is tilted with multiple struts protruding through the ivc wall and into the duodenum.Following month, patient went surgery for exploratory laparotomy and open retrieval of the ivc filter.The ivc filter was clamped proximally and distally to the ivc filter and an incision at the ivc filter apex was made, grasped with heiss clamp and was pulled.Three months followed by, patient had a septic shock caused by multidrug resistant pseudomonas bacteremia, suspected secondary to the open ventral abdominal wall wound with enterocutaneous fistula.Treatment with merrem was initiated; the patient developed a new left, frontoparietal subarachnoid hemorrhage.Some days later, patient¿s condition declined further and expired.Therefore, the investigation is confirmed for filter tilt, filter limb perforation and unintended movement.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: 05/2012).

Event Description

It was reported through the litigation process that some time post vena cava filter deployment (date not provided) the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.New information: 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 the filter tilted laterally with hook contacting ivc wall and struts perforated ivc wall.The device was removed via an open abdominal procedure and the patient subsequently expired.

• 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: 9174352
• MDR Text Key: 161792668
• Report Number: 2020394-2019-03835
• 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: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: GFTB3627
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/20/2019
• 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, SEVELAMER, INSULIN, BACITRACIN; CHLORASEPTIC, CINACALCET, CORDARONE; GLUCAGON, IMODIUM, MENTHOL-ZINC OXIDE; NYSTATIN, PROAMATINE, PROCRIT, PROTONIX; RISAMINE, SIMETHICONE, ALBUTEROL; WARFARIN, SENSIPAR, NEPHRO, GABAPENTIN
• Patient Outcome(s): Death; Hospitalization; Required Intervention