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

Catalog Number EC500F

Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 04/13/2017

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records was performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiry date: 03/2013.

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 the filter struts perforated into organs.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

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 the filter tilted, struts perforated, detached and the patient reportedly experienced abdominal pain.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

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 seven years of post deployment, computed tomography of abdomen and pelvis was performed, and result showed that the hook of the bard eclipse retrievable inferior vena cava filter was at the t12-l1 interspace.The inferior vena cava filter was tilted laterally, and the hook contacted the inferior vena cava wall.All the struts of the inferior vena cava filter perforated the inferior vena cava up to 17mm.There was a lateral strut that perforated the inferior vena cava by 10 mm and resided within the right renal pelvis.There was a medial strut that perforated the inferior vena cava by 17mm and contacted the aorta.No hemorrhage seen.No thrombus was seen within the inferior vena cava.No fracture fragments were identified.This was unchanged from the prior computed tomography scan performed due to abdominal pain five months earlier.One of the legs extended through the surface of the wall of the abdominal aorta posterolaterally towards the right.The legs of the inferior vena cava filter peripherally extended through its wall entered the adjacent pericaval fat.There was a linear radiopaque foreign body identified within the duodenal lumen at the level of the ampulla measured approximately 13mm in length.This was also unchanged from the computed tomography scan performed six months earlier except the finding that demonstrated a thrombus within the inferior vena cava or filter cannot be evaluated on the noncontrast study.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc), filter tilt and filter limb detachment.Based upon 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: 03/2013 section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: ECLIPSE FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11869662
• MDR Text Key: 252144439
• Report Number: 2020394-2021-80458
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K093659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EC500F
• Device Lot Number: GFUB1671
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALBUTEROL, AMLODIPINE, ASPIRIN, ATENOLOL; ALBUTEROL, AMLODIPINE, ASPIRIN, ATENOLOL; ATORVASTATIN, CILOSTAZOL, CLOTRIMAZOLE; ATORVASTATIN, CILOSTAZOL, CLOTRIMAZOLE; CYANOCOBALAMIN, COLACE, GABAPENTIN; CYANOCOBALAMIN, COLACE, GABAPENTIN; GLUCOTROL, LANTUS, SENNA, AND TOLTERODINE; GLUCOTROL, LANTUS, SENNA, AND TOLTERODINE; ALBUTEROL, AMLODIPINE, ASPIRIN, ATENOLOL; ATORVASTATIN, CILOSTAZOL, CLOTRIMAZOLE; CYANOCOBALAMIN, COLACE, GABAPENTIN; GLUCOTROL, LANTUS, SENNA, AND TOLTERODINE
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Weight: 64