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

Catalog Number EC500F

Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Injury (2348); Cardiac Perforation (2513); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/18/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown.Investigation summary: the device was not returned.Images and medical records were not provided.The investigation is inconclusive for the alleged filter tilt, perforation of the ivc, filter migration, limb detachment and retrieval difficulties as no objective evidence has been provided to confirm any alleged deficiency with the filter.Additionally, the investigation is inconclusive for pe post deployment.However, the relationship to the filter is unknown.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.(b)(4).

Event Description

It was reported through the litigation process that the filter tilted, detached, perforated , migrated and embedded.The patient reportedly experienced dvt's, stenosis and post thrombotic syndrome and further reported that the patient had to have an open-chest surgery to retrieve the filter after an unsuccessful attempt, however the current status of the patient is unknown.

Manufacturer Narrative

H10: 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 one week later, computed tomography of abdomen and flank was performed which showed there was an inferior vena cava filter in place.After six years, the patient had right-sided abdominal pain, computed tomography of abdomen and pelvis without contrast was performed which showed there was a filter within the inferior vena cava in apparent good position.After one years and one-month, inferior vena cavogram was performed for evaluation of inferior vena cava filter position which showed retrievable inferior vena cava filter was projected over the lumbar spine, superior tip at the level of the inferior endplate of l2.The inferior vena cava filter was demonstrated at the l2 and l3 levels.At least one of the legs of the filter seems to be fractured.The linear metal object structure measuring approximately 5 cm in length was projected over the right lateral aspect of the l5 vertebral body.After three weeks, computed tomography of abdomen and pelvis was performed for evaluation of filter removal which showed retrievable inferior vena cava filter was present at the l3 level.The filter was tilted anteriorly, resulting in placement of the hook adjacent to the anterior wall of the inferior vena cava.One of the posterior filter legs seems to be bent in a posterior direction.The patent leg and the two anterolateral legs protrude, beyond the expected location of the wall of the inferior vena cava, though it was possible that the wall of the inferior vena cava was "tented" outward by the filter legs.The most anterior leg of the filter resides in a venous tributary anterior to the inferior vena cava, though the proximal aspect of this leg seems to remain attached to the reminder of the filter.A linear metal object extending inferolaterally and anteriorly in the fat inferior to the right kidney may represent a broken leg of the filter in the infrarenal fat.No inferior vena cava or iliac vein thrombus was demonstrated.After one-month, inferior vena cavogram was performed for percutaneous transvenous inferior vena caval filter removal which showed no significant amount of thrombus could be within the filter.The visualized inferior vena cava was patent.There appeared to be some narrowing at the level of the filter.There was a linear metallic object projecting approximately 1.5 inches to the right of the existing filter.Multiple surgical clips in the abdomen also noted.Through an 11-french sheath, a snare used to try to grasp the cephalad hook of the filter.After multiple attempts, it became clear that the hook buried in the wall of the inferior vena cava.Multiple obliquities were obtained in order to verify that the tip could not grasped by the snare device.The snare device system removed over an amplatz wire, and a 16 french 45 cm sheath advanced into the inferior vena cava.A 12 french 45 cm sheath also advanced telescopically into the inferior vena cava through the 16 french sheath.Using 65 cm bronchoscopy forceps, the soft tissue overlying the hook of the filter gradually removed.It could be seen that one of the wires on the right side of the filter discontinuous with the filter at the apex.This grasped with the forceps and removed.A second discontinuous wire identified, this grasped and removed.Using the forceps, the hook gradually pulled away from the wall into the inferior vena cava.The hook was eventually grasped, and the filter collapsed by advancing the 16 french sheath over the filter.The forceps and the filter were then pulled into the french sheath and the french sheath removed.The filter then laid out on the table and inspected.Evaluation of the images revealed a short residual linear metallic structure at the anticipated location of the filter legs.The snare device advanced back into the inferior vena cava and attempts were made to grasp the wire tip.Based on fluoroscopic imaging, it appeared that the wire tip of the linear metallic structure completely extravascular and not accessible for removal.The previously identified linear metallic structure on the patient's right also extravascular and no attempt made to retrieve it.A venogram obtained which showed mild narrowing of the inferior vena cava at the level of the filter insertion but no frank extravasation.The narrowing did not appear to flow-limiting.With that, an appropriate endpoint had been reached and the sheath removed.Hemostasis achieved with a purse string mediated closure which was removed before the patient taken off the fluoroscopy table.On the next day, the patient was diagnosed with embolized fragment of an inferior vena cava filter, patient presented looking at abdominal wall for possible hernia repair, at that time computed tomography scan was identified as having a foreign object perforating patient right ventricle.This was then felt to be consistent with an inferior vena cava filter fragment, when the filter was inspected radiologically in the abdomen, it appeared that one of the struts was missing.The inferior vena cava filter was removed previously and there was a suspicion of wire fragment in apex of right of right ventricle.Repeat computed tomography scan again confirmed the presence of this wire.This was grasped with a hemostat and removed.Therefore, the investigation is confirmed for the alleged perforation of the inferior vena cava, filter migration, material deformation, filter limb detachment, filter tilt and retrieval difficulties.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.H10: (expiry date: 06/2013).H11: 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.

Event Description

It was reported through the litigation process that the filter tilted, detached, perforated, migrated and embedded.The patient reportedly experienced that deep vein thrombosis, stenosis and post thrombotic syndrome and further reported that the patient had to have an open-chest surgery to retrieve the filter after an unsuccessful attempt, however 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
• MDR Report Key: 8753398
• MDR Text Key: 149799611
• Report Number: 2020394-2019-01350
• 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: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• 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: GFUE3223
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRIN, CALCIUM CARBONATE AND DIOVAN; CLORPACTIN, DEMADEX, METHADONE, MULTIVITAMIN; MORPHINE, BENADRYL, TYLENOL, HEPARIN; PREVACID, WELLBUTRIN, ZOFRAN, PHENERGAN
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 122