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

Catalog Number MD800F

Device Problems Complete Blockage (1094); Occlusion Within Device (1423); Difficult to Remove (1528); Material Deformation (2976)

Patient Problems Occlusion (1984); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2015

Event Type  malfunction  

Manufacturer Narrative

No device, no medical records or no medical images have been made available to the manufacturer.As the lot number for the device has not been provided, a review of the device history records could not be performed.The investigation of the reported event is currently underway.

Event Description

It was reported that approximately 18 months post vena cava filter deployment, during a scheduled filter retrieval, ivc occlusion was discovered at the level of the filter.No attempts were made to retrieve the filter.No other pertinent medical information was provided surrounding the events.Current patient status is unknown.

Manufacturer Narrative

Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided.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: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is inconclusive for an occluded ivc at the level of the filter.Based upon the available information, the definitive root cause for this event is unknown.Labeling review: the current ifu (instructions for use) states: warnings: 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: caval thrombosis/occlusion 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.

Manufacturer Narrative

Medical records review: the patient had a prophylactic inferior vena cava filter placed for prolonged immobility and intracranial hemorrhage.The right groin was prepped and draped in usual sterile fashion.The right common femoral vein was accessed and the filter was successfully deployed in an infrarenal location.The patient tolerated the procedure well without immediate complication.Conclusion: the device was not returned.Images were not received.Medical records were provided.The medical records allege a vena cava filter was implanted successfully in an infrarenal location via the right common femoral vein.No deficiencies were reported within the medical records.The investigation is inconclusive for the reported event.Based upon the available information, the definitive root cause for this event is unknown.(b)(4).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

New information received - it was reported by the patient a vena cava filter was deployed in conjunction with a trauma situation/motor vehicle accident.After an unknown amount of time post filter deployment, an unsuccessful percutaneous filter retrieval attempt was performed.Based on medical records received from the patient, it was identified a vena cava filter was deployed successfully for dvt prophylaxis.The patient tolerated the procedure well.No additional information was received in the medical records provided.

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.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately one year and six months later, first attempt was made to retrieve the inferior vena cava filter from the patient¿s body.Through the ultrasound-guided right internal jugular vein access, a 0.035 inch j wire was advanced through the micropuncture sheath into the inferior vena cava.A spot magnification view of the bard meridian filter demonstrated the filter was intact and at the level of l2-l3.There was no significant tilt.The arms and legs were contracted compared to prior images.The guidewire was then attempted to be advanced into the inferior vena cava below the level of the filter; however, resistance was encountered at the level of the filter.The j wire was exchanged for a 0.035 inch stiff glidewire, and again attempts were made to advance beyond the level of the filter; these were unsuccessful.A 5 french kumpe catheter was advanced over the wire and attempts were made; however, it was not possible to traverse beyond the level of the filter secondary to occlusion of the inferior vena cava at this level.An injected contrast demonstrated chronic occlusion of the inferior vena cava at the level of the filter.As the patient had no complaints in regard to this filter, the procedure was terminated.Hemostasis was obtained using manual compression.After four years and six months, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed that there was an inferior vena cava filter in place.The cava inferior to the level of this filter was occluded.On the next day, second attempt was made to retrieve the chronic total occluded inferior vena cava filter from the patient¿s body.Through the ultrasound-guided right internal jugular vein access, a sheath was up sized to 11-french sheath.Using a 15 mm loop snare, the physicians were able to snare the hook of the inferior vena cava filter; however, there was significant adherence of the inferior vena cava filter to the surrounding scar tissue, as a result of which the physicians were unable to retrieve the filter in this fashion.At this point, the 16 french 45 cm sheath was switched out to 16 french 50 cm laser sheath and this was done without losing snare capture of the inferior vena cava filter.Using gentle taps, the physicians were able to completely break down the scar tissue around the inferior vena cava filter and completely retrieved the inferior vena cava filter into the sheath.The laser sheath with the inferior vena cava filter was completely removed and the filter was sent to pathology.A cavogram demonstrated a patent vena cava without any evidence of extravasation.Hemostasis was achieved and a compressive dressing was applied.On the same day, the surgical pathology report¿s gross description mentioned that ¿the specimen designated as inferior vena cava (ivc) filter was received in fresh in a container labeled with the patient¿s name and medical record number and consisted of a bundle of wires that measured 4 cm in length entailed by a clamp on one end that measured 0.4 cm.The very end had a little filter on it which measured 2 cm in length.The specimen was placed aside for patient pick-up¿.Therefore, the investigation is confirmed for the alleged filter occlusion, material deformation and retrieval difficulties.Based upon the available information, the definitive root cause for this event 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 eighteen months post vena cava filter deployment, during a scheduled filter retrieval, inferior vena cava occlusion was discovered at the level of the filter.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.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 in conjunction with trauma situation/motor vehicle accident.Approximately eighteen months post vena cava filter deployment, during a scheduled filter retrieval, inferior vena cava occlusion was discovered at the level of the filter.The device has not been removed after an attempted but unsuccessful percutaneous removal procedure.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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.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 - FEMORAL
• 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: 5478498
• MDR Text Key: 39854544
• Report Number: 2020394-2016-00237
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800F
• Device Lot Number: GFXF3382
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2013
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 121 KG
• Patient Ethnicity: Non Hispanic