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

Catalog Number EC500F

Device Problems Detachment of Device or Device Component (2907); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); No Consequences Or Impact To Patient (2199)

Event Date 10/29/2015

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: as the lot number for the device was not provided, a manufacturing review could not be performed.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.The information provided by bard 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 bard.

Event Description

It was reported through the litigation process that sometime post vena cava filter deployment the filter perforated through the intestine and spinal column.There were no reported attempts to retrieve the filter.The status of the patient is unknown.

Event Description

It was reported through the litigation process that sometime post vena cava filter deployment the filter perforated through the intestine and spinal column.There were no reported attempts to retrieve the filter.The status of the patient is unknown.

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based upon the available information, the definitive root cause is unknown.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.

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately five years six months post filter deployment, patient had abdominal pain.Subsequent, ct revealed all the arms and legs of the filter have penetrated through the wall of the ivc into the pericaval/mesenteric fat with two of the legs penetrating into the duodenum and two of the legs in contact with the anterior periosteum of the vertebra, possibly embedded within it.Therefore, the investigation is confirmed for perforation of the ivc.However, the investigation is inconclusive for 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: 01/2013).

Event Description

It was reported through the litigation process that sometime post vena cava filter deployment the filter allegedly perforated through the intestine and spinal column.There were no reported attempts to retrieve the filter.The status of the patient is unknown.New information: 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 detached and perforated.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
• MDR Report Key: 7656164
• MDR Text Key: 113002395
• Report Number: 2020394-2018-01051
• 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,Followup
• Report Date: 03/05/2020

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 Catalogue Number: EC500F
• Device Lot Number: GFUA1249
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/26/2018; 02/21/2020
• Supplement Dates FDA Received: 08/22/2018; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COUMADIN, OMEPRAZOLE, NORCO, POTASSIUM; CYCLOBENZAPRINE, GABAPENTIN, ONDANSETRON; TRAMADOL, LEVOTHYROXINE
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 127