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

Model Number DL900F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976); Migration (4003)

Patient Problems Extravasation (1842); Hematoma (1884)

Event Date 11/02/2015

Event Type  Injury  

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 had migrated with the hook being embedded in the superior aspect of the left renal vein and filter tilted sideways and kinked.The device and fractured struts have not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

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 one month later post filter deployment, patient was planned for filter retrieval procedure.Through the right internal jugular vein approach, a benston wire was advanced to the level of 2nd lumbar vertebra.A cook filter retrieval system was advanced, and venography was performed.The study showed that filter had migrated with the hook being embedded in the superior aspect of the left renal vein.Multiple attempts were made to hook the origin of the filter; however, these were unsuccessful.A snare technique was employed in order to gain access to the area of the filter below the level of the hook.This was done and the filter was able to be retrieved and the hook removed from the left renal vein to dislodge the filter from where it had previously been sitting.During this process, the filter hook came out of the area where the left renal vein.Visualization of the filter in the vena cava was performed with venogram.However, upon removal of the looped hook that took place in order to dislocate the filter from the left renal vein.The filter was caught into the wire and was unable to be separate.Retrieving the filter then caused the filter to tilt to its side and kink.Given the findings and the oblique angle which the filter was located, the decision was made to prep the groin and try and snare the filter from below in order to straighten it or to flip the filter and retrieve it from below.It was deemed that it would be unsafe to leave the filter in a tilted position in the patient given the severity of the tilt.Multiple attempts were made to snare the filter from below and above.These were all unsuccessful.During maneuvering the sheath and snare had been passed from the right common femoral vein to the level of the filter.A sheath was passed in order to gain better access for allowing for double snares to be employed.There appeared to be dislocation of the filter and the venography demonstrated there was extravasation from the filter hook.During this point of extravasation, the patient¿s blood pressure became labile.Aggressive resuscitation with blood products was performed.The decision was made to abort the procedure at this point in time after a catheter was passed from the patient¿s right common femoral sheath site which verified that the caval wall had been violated by the filter.Aggressive transfusion protocol was initiated.After one week, a computed tomography of abdomen and pelvis was performed to evaluate the filter.The study showed that the filter extends outside of the vein, its long axis was transverse, tip about 3 cm lateral to the right side of the inferior vena cava.A large retroperitoneal hematoma was noted on the right side.After five months, a computed tomography of abdomen and pelvis was performed which showed inferior vena cava filter was predominantly extra caval above the level of the bifurcation of the inferior vena cava and extends into a localized fluid collection.This was likely a post op hematoma containing the filter.The prongs of the filter remain in the inferior vena cava that appears partially collapsed not over distended to suggest inferior vena cava thrombosis although opacification was considered suboptimal.Therefore, the investigation is confirmed for the alleged filter tilt, perforation of the inferior vena cava, filter migration, filter detachment, material deformation and retrieval difficulties.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: 08/2018).

• Brand Name: DENALI FEMORAL 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: 13754733
• MDR Text Key: 287106253
• Report Number: 2020394-2022-90124
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• 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: 03/14/2022

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 Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFZG3112
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/14/2022
• 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: PERICOLACE, LEVOTHYROXINE, PANTOPRAZOLE AND LASIX
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 141 KG
• Patient Race: Black Or African American