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 Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/30/2017

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 07/2015).

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.Approximately four years six months post filter deployment, the patient experienced a computed tomography scan that revealed that the filter was tilted, migrated to heart, struts detached and perforated.The device was removed percutaneously.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.Approximately four years and six months post filter deployment, the patient had a computed tomography scan that revealed that the filter was tilted, migrated to heart, struts detached and perforated.The device was removed percutaneously.It was further reported that the detached strut retained within the fat anterior to inferior vena cava and posterior to duodenum.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, four years five months of post deployment, inferior vena cavogram was revealed that the inferior vena cava filter was noted to be tilted with the hook and cone of the filler appeared to be embedded within the right lateral wall of the inferior vena cava.Two of the struts of the filter penetrated through the left lateral wall of the inferior vena cava.Ultrasound images did confirm that the hook and cone of the inferior vena cava filter was embedded within the wall of the inferior vena cava.Additionally, there were two displaced struts.Subsequent magnified fluoroscopic spot images confirmed that two of the struts were fractured and embedded within the wall of the inferior vena cava.Around, twenty days later, cone beam computerized tomography was revealed that this strut did indeed reside within the fat anterior to the inferior vena cava and posterior to the duodenum.Around, four days later, again noted that inferior vena cava filter fractured with fragment near spine.Around, one month later, inferior vena cava filter retrieval was performed.Access was gained via right internal jugular vein.Using this access, a 12-french sheath was placed and advanced into the distal right common iliac vein.Contrast was injected and inferior venacavogram performed.This showed no inferior vena cava thrombus.The sheath was retracted just cranial to the inferior vena cava filter.A 9-french sheath was then advanced coaxially through the 12-french sheath.Attempts were then made to snare the inferior vena cava filter hook.These attempts were unsuccessful.One of the fractured struts was removed with the snare, however.The 9-french sheath was then removed.A rigid endobronchial forceps was then advanced through the 12 french sheath and used to capture the cone of the filter.The sheath was not large enough in diameter to advance over the filter.Therefore, the forceps were used to pull the hook and cone of the filter off the inferior vena cava filter wall.A separate access was then obtained in the right internal jugular vein with ultrasound guidance with placement of a new 12-french sheath within the inferior vena cava.Through this sheath, the snare was advanced and used to capture the hook of the filter.The filter was then removed through this sheath.Subsequent inferior venacavogram showed no inferior vena cava perforation.Spot images over the abdomen revealed a single remnant strut.Examination of the retrieved inferior vena cava filter confirmed that all other struts/components of the filter were accounted for.After filter retrieval, one of the fractured struts remains extracaval.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc), filter tilt, filter limb detachment and retrieval difficulties.However, the investigation is inconclusive for material deformation of the filter and filter migration.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: 07/2015).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.

• 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: 11683860
• MDR Text Key: 245987588
• Report Number: 2020394-2021-80313
• 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: 05/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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: GFWF2279
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AZATHIOPRINE, MEROPENEM, AZTREONAM, XARELTO; AZATHIOPRINE, MEROPENEM, AZTREONAM, XARELTO; CIPROFLOXACIN, CLINDAMYCIN, LINEZOLID, BENADRYL; CIPROFLOXACIN, CLINDAMYCIN, LINEZOLID, BENADRYL; CLARITIN, TYLENOL, NORCO, SYNTHROID, TESSALON; CLARITIN, TYLENOL, NORCO, SYNTHROID, TESSALON; DIPHENHYDRAMINE, ATORVASTATIN, FUROSEMIDE; DIPHENHYDRAMINE, ATORVASTATIN, FUROSEMIDE; LOVENOX, WARFARIN, ALLOPURINOL, AMIODARONE; LOVENOX, WARFARIN, ALLOPURINOL, AMIODARONE; AZATHIOPRINE, MEROPENEM, AZTREONAM, XARELTO; CIPROFLOXACIN, CLINDAMYCIN, LINEZOLID, BENADRYL; CLARITIN, TYLENOL, NORCO, SYNTHROID, TESSALON; DIPHENHYDRAMINE, ATORVASTATIN, FUROSEMIDE; LOVENOX, WARFARIN, ALLOPURINOL, AMIODARONE
• Patient Outcome(s): Other
• Patient Age: 66 YR