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

Catalog Number MD800F

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); No Consequences Or Impact To Patient (2199)

Event Date 06/07/2012

Event Type  malfunction  

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 status post trauma with prolonged immobility and could not be anticoagulated was scheduled for filter placement.The right common femoral vein was accessed and a venogram demonstrated widely patent inferior vena cava and iliac veins.The filter was advanced and deployed below the level of the renal veins.Completion venogram demonstrated good position of the filter in the infrarenal inferior vena cava.The sheath was removed and pressure was applied.The patient did well during the procedure.Approximately two months post filter deployment, a filter retrieval procedure was performed without success.Approximately five months post filter deployment, the patient presented for a second filter retrieval procedure.The right internal jugular vein was accessed and a venogram demonstrated widely patent inferior vena cava and iliac veins.Multiple devices were used in an attempt to remove the filter; however, the filter was unable to be retrieved due to the filter being tilted and embedded into the inferior vena cava wall.Completion venogram demonstrated the filter to be in the same position as well as patency of the inferior vena cava and iliac veins.The procedure was concluded and the sheath was removed.The patient was transferred to the recovery room in stable condition.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the device was not returned.Images were not provided.Medical records were provided and reviewed.A vena cava filter was successfully deployed at level of renal veins.Two months post filter deployment, a retrieval attempt failed to remove the filter.Five month post filter deployment, another unsuccessful retrieval attempt was made.At that time is was noted that the apex of the filter was embedded in the wall of the ivc.Based on the medical records provided the investigation can be confirmed for a tilted filter and difficulties in removing the filter.Per the provided medical records, the filter was tilted.A tilted filter could lead to retrieval difficulties.However, 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.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 successfully, the reason for the filter deployment was not provided.No alleged deficiency with the device was reported.No other information regarding this event was provided.The patient status at this time is unknown.New information received: medical records were received and reviewed.Approximately two months post filter deployment in a patient status post trauma, a filter retrieval procedure was performed without success.Approximately five months post filter deployment, the patient presented for a second retrieval procedure.Multiple devices were used in an attempt to retrieve the filter; however, the procedure was unsuccessful due to the filter being tilted and embedded into the inferior vena cava wall.The procedure was concluded and the patient was transferred to the recovery room in stable condition.No additional information was provided in the medical records received.

Event Description

It was reported that a vena cava filter was deployed successfully, in a patient status post trauma.Approximately two months post filter deployment, a filter retrieval procedure was performed without success.Approximately five months post filter deployment, the patient presented for a second retrieval procedure.Multiple devices were used in an attempt to retrieve the filter; however, the procedure was unsuccessful due to the filter being tilted and embedded into the inferior vena cava wall.The procedure was concluded and the patient was transferred to the recovery room in stable condition.No additional information was provided in the medical records received.The patient status at this time 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 two months post filter deployment, filter retrieval was scheduled.Through the ultrasound-guided right internal jugular vein access, multiple devices were used and a venogram showed that the filter was tilted significantly.Some of the legs of the inferior vena cava filter were inside the right renal vein and the apex of the filter was stuck on the wall of the inferior vena cava.A retrieval cone was passed and attempted to straighten up the filter to pull it out, but unsuccessful.Then, a snare was passed and multiple attempts were made to capture the apex of the filter to sheath it and pull it out, but unsuccessful.Approximately two months later, second retrieval attempt was scheduled.The venogram showed that the filter and the inferior vena cava were around the level of the renal veins and it was tilted and embedded into the wall of the inferior vena cava.Then multiple snares and wires were passed over the 10-french sheath to retrieve the filter with a cone retrieval device; however, the filter was unable to be pulled out due to the apex of the filter been tilted and embedded into the wall of the inferior vena cava.Approximately four years later, computed tomography revealed the apex of the inferior vena cava filter was tilted towards the left side wall of the inferior vena cava, which could be partially or completely embedded within the wall of the inferior vena cava just above the level of the left renal vein.One of the inferior vena cava filter struts was fractured and dislocated from the filter and could be partially or completely embedded within the wall of the inferior vena cava above the level of the right renal vein.Several struts perforated the inferior vena cava.Therefore, the investigation is confirmed for filter limb detachment, perforation of the inferior vena cava (ivc), retrieval difficulties and filter tilt.Per medical records, multiple attempts were made to engage the apex of the filter using snare and retrieval cone but were unsuccessful due to filter tilt.This could have contributed to the retrieval difficulties.However, the definitive root cause is unknown.Labelling 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: b6, d4(expiry date: 01/2013),.

• 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
• MDR Report Key: 6209352
• MDR Text Key: 63482287
• Report Number: 2020394-2016-01210
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K112497
• 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: 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2013
• Device Catalogue Number: MD800F
• Device Lot Number: GFWA0429
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HYDROCHLOROTHIAZIDE, PRINIVIL, VENTOLIN HFA; HYDROCHLOROTHIAZIDE, PRINIVIL, VENTOLIN HFA; HYDROCHLOROTHIAZIDE, PRINIVIL, VENTOLIN HFA
• Patient Age: 37 YR
• Patient Weight: 106