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

Catalog Number EC500F

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 10/22/2018

Event Type  Injury  

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 year and twenty-seven days later, the patient was positive for abdominal pain.Approximately six years and one month later, the patient reported to the hospital with abdominal pain and computed tomography (ct) revealed that there was an infrarenal inferior vena cava filter.Approximately one week and one day later a venous duplex lower extremity bilateral showed that on both right and left, there were evidences of occlusive, acute deep vein thrombosis in the common femoral, femoral in proximal thigh, popliteal, posterior tibial and peroneal veins.Subsequently two days later, venous duplex showed that there was evidence of occlusive, acute deep vein thrombosis in the common femoral, femoral in proximal thigh, popliteal, posterior tibial and peroneal veins bilaterally.Approximately eight months and twenty-two days later, computed tomography (ct) revealed that the inferior vena cava filter was mildly tilted posteriorly 5-degrees.The apex of the inferior vena cava filter was less than 2 cm below the most inferior renal vein.The inferior vena cava filter strut penetrated approximately 6 mm.There were no fractured or bent struts.Overall, the vena cava was diminutive and could be thrombosed.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava (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.The current instructions for use states: the safety and effectiveness of this device has not been established for morbidly obese patients.Open abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter.(expiry date: 08/2013).

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 struts perforated beyond the inferior vena cava wall.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.

• 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
• 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: 11070904
• MDR Text Key: 223590528
• Report Number: 2020394-2020-06503
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093659
• 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: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2020
• 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: GFUG3503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2020
• 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
• Treatment: COUMADIN, BUSPIRONE, FUROSEMIDE AND GLYBURIDE.; DESYREL, WELLBUTRIN, HYZAAR, XYZAL AND CARDIZEM.; LABETALOL, SYNTHROID, CYMBALTA, NEXIUM AND CORGARD.; LISINOPRIL, CANAGLIFLOZIN AND FENOFIBRATE.; LORTAB, HYDROXYZINE PAMOATE AND ONDANSETRON.; MELATONIN, OXYCODONE, PROMETHAZINE AND LOVENOX.; OMEPRAZOLE, CIPROFLOXACIN AND METRONIDAZOLE.
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 143