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

Catalog Number MD800J

Device Problems Partial Blockage (1065); Malposition of Device (2616); Patient-Device Incompatibility (2682)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Abdominal Pain (1685); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

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.This is the only event reported to date for this lot number and failure mode.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review: the patient with recurrent deep venous thrombosis and post thrombotic syndrome was scheduled for placement of an inferior vena cava (ivc) filter.The right internal jugular vein was accessed and an inferior venacavogram demonstrated a widely patent ivc, no venous anomalies and identified the level of the renal veins.The filter was then deployed in the infrarenal ivc without incident.Hemostasis was achieved.Image/photo review: as medical images and photos were not provided, a review could not be performed.Conclusion: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive for the alleged tilted filter 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: the current ifu (instructions for use) states: warnings/potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.- filter tilt - filter malposition note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.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 that a vena cava filter was deployed for a history of deep vein thrombosis/pulmonary embolism.At sometime post filter deployment, the filter allegedly tilted and embedded in the caval wall.Reportedly, no filter retrieval procedures have been performed.There was no reported patient injury.

Event Description

It was reported through the litigation process that a vena cava filter was deployed for a history of deep vein thrombosis/pulmonary embolism.At sometime post filter deployment, the filter allegedly tilted and embedded in the caval wall.Reportedly, no filter retrieval procedures have been performed.There was no reported patient injury.

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, two months and two weeks of post deployment, computerized tomography scan abdomen and pelvis without contrast renal stone protocol was demonstrated that there was an inferior vena cava filter in place.Inferior to the inferior vena cava filter, the inferior vena cava appears larger and arguably may have some increased density within it extending into the common iliac veins and into the deep veins of the lower extremities including the superficial femoral veins.There was also slight hazing ground these vessels suggested.Around, one month and two weeks later, venography of bilateral lower extremities and inferior vena cava showed one-hundred percent occlusion of the inferior vena cava distal to inferior vena cava filter.Vena cavagram above the filter was carried out, demonstrated patent flow in the inferior vena cava above the filter.Below the filter there was no flow present.Around, one year one month later, patient has an inferior vena cava filter with 100% thrombosis of the inferior vena cava distal to the filter.Around, five years and nine months later, patient presented for evaluation of leg swelling.Patient has inferior vena cava filter in place states that it has perforated and was clotted.After, twenty days, lumbosacral spine radiographs showed that there was a retrievable inferior vena cava filter in position, with the hook of the filter terminating at the level of the li-l2 disc space.The contour of the filter suggests caval nan-owing.Around, one week later, an ultrasound of the lower extremities inferior vena cava filter that was partially blocked.The patient having abdominal pain and discomfort that radiates into low back.Partially occluded inferior vena cava filter noted.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc), and partial occlusion of the inferior vena cava (ivc).However, the investigation is inconclusive for filter tilt.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 current instructions for use states: warnings: - movement, migration or tilt of the filter are known complications of vena cava filters.Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted.Potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.- filter tilt.- filter malposition.H10: b6,b7,g3, h6(patient, device).H11: b1,g1,h1,h6(method, conclusion).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: MERIDIAN FILTER SYSTEM - JUGULAR
• 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: 6837829
• MDR Text Key: 85122416
• Report Number: 2020394-2017-01072
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102511
• 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,Followup
• Report Date: 11/29/2021

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 Expiration Date: 09/30/2013
• Device Catalogue Number: MD800J
• Device Lot Number: GFWH2377
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 09/01/2017
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2012
• 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: ASPIRIN, VITAMIN B COMPLEX; HYDROCODONE BITARTRATE/ACETAMINOPHEN; LOVENOX, CYANOCOBALAMIN, ULTRAM, BACTRIM DS; MILK OF MAGNESIA, ONDANSETRON, AND ZOLPIDEM; NICODERM, MOTRIN, MORPHINE; PENICILLIN V POTASSIUM, THIAMINE HCI; XARELTO, NORCO, GABAPENTIN, COUMADIN
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White