MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER

Catalog Number UNKNOWN FILTER

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Extrusion (2934); Migration (4003)

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

Event Date 05/18/2006

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 filter tilt and 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 approximately eleven years post vena cava filter deployment a ct scan showed the ivc filter tilted to the right with the cone lying on the right lateral wall of the ivc.Reportedly, one of the legs perforated through the ivc wall into the pericaval/mesenteric fat and one leg perforated into the right lateral wall of the aorta.There were no reported attempts made to the retrieve the filter.The status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.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.Post-deployment computed tomography of the abdomen and pelvis showed that an inferior vena cava filter was in place, and it was reported that the patient had abdominal pain.After two days, it was reported that an inferior vena cava filter with struts extended beyond the inferior vena cava.Around, one month and twenty-nine days later, computed tomography of neck, chest, abdomen, and pelvis with contrasts showed that there was an inferior vena cava filter present with a very small caliber inferior vena cava at the level of the filter.Around, ten years and ten months later, computed tomography enterography showed that a bard type inferior vena cava filter was positioned below the renal veins.The filter was tilted to the right with its cone lay on the right lateral wall of the inferior vena cava possibly embedded in it.One of the arms of the filter was fractured and separate from the filter lay outside of the inferior vena cava in the pericaval or mesenteric fat.The legs of the filter have penetrated through the wall of the inferior vena cava into the pericaval or mesenteric fat.One of the legs had penetrated the right lateral wall of the aorta.The inferior vena cava beginning at the level of the cone of the filter and extended to its bifurcation was very stenotic at some points measured approximately 8 mm in diameter.Around, ten months and fifteen days later, single view abdomen showed that an inferior vena cava filter was identified at the l3-l4 level.This was similar in appearance to prior radiographs performed one month before.Therefore, the investigation is confirmed the perforation of the inferior vena cava (ivc), filter tilt and filter limb detachment.However, the investigation is inconclusive for 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.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 a vena cava filter was placed in a patient in conjunction with trauma situation/motor vehicle accident.Approximately eleven years post vena cava filter deployment, a computed tomography scan showed that the filter tilted to the right with the cone lying on the right lateral wall of the inferior vena cava and one of the legs perforated through the inferior vena cava wall into the pericaval/mesenteric fat.Further more, it was alleged that the filter migrated and struts detached and the detached strut retained outside the inferior vena cava in pericaval/mesenteric fat.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: VENA CAVA FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7623624
• MDR Text Key: 111859324
• Report Number: 2020394-2018-00941
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• 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: 08/05/2021

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: UNKNOWN FILTER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/20/2018
• Supplement Dates Manufacturer Received: 07/08/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCOCET, PHENERGAN, AND COUMADIN; TYLENOL, AUGMENTIN, LOVENOX, LEVAQUIN
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 120