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

Catalog Number MD800J

Device Problems Difficult to Remove (1528); Malposition of Device (2616)

Patient Problems Hematoma (1884); Pain (1994)

Event Date 01/06/2013

Event Type  Injury  

Manufacturer Narrative

No medical images have been made available to the manufacturer.Medical records were provided and reviewed.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: a filter was placed in the suprarenal vena cava for thrombus in the inferior vena cava (ivc).Follow-up cavogram revealed satisfactory result.Two days later, the patient presented to the emergency department (ed) with low back pain, abdominal pain, and associated nausea and vomiting.A ct scan was performed which identified the suprarenal filter in the intrahepatic portion of the ivc and a small area of stranding in the region of the right adrenal gland likely a small hematoma.There was no active extravasation.Interventional radiology reviewed the ct scan and identified that there was stranding around the recently placed suprarenal filter compatible with a hematoma without active extravasation.It was decided to keep the patient for hemodynamic monitoring and hold anticoagulation for 48 hours.During the course of admission, it was discovered that the back pain which brought the patient to the ed started a couple of hours after taking a self administered anticoagulation injection.Approximately two months later, the patient was scheduled for attempted filter removal.The right internal jugular vein was accessed and a cavagram showed no apparent luminal thrombus.An attempt was made to retrieve the filter using multiple wires, catheters, balloons and snares without success.Approximately three months post filter deployment, the patient presented for a second attempt at filter retrieval.The right internal jugular vein was accessed and multiple attempts to snare the filter were made; however, the hook of the filter could not be engaged due to angulation of the filter apex with the hook embedded in the wall of the ivc.At that point laparoscopic forceps were advanced and again, multiple attempts to retrieve the filter were made, but the apex of the filter could not be successfully engaged or displaced from the ivc wall.No further information is noted regarding the patient¿s current status.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 a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism.Some time post filter deployment, the filter allegedly tilt and embedded in the wall of the ivc; after two unsuccessful removal procedures, the filter was successfully removed percutaneously.The patient allegedly experienced bleeding and was hospitalized.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Medical records review: a filter was placed in the suprarenal vena cava for thrombus in the inferior vena cava (ivc).Follow-up cavogram revealed satisfactory result.Two days later, the patient presented to the emergency department (ed) with low back pain, abdominal pain, and associated nausea and vomiting.Interventional radiology reviewed a ct scan and identified that there was stranding around the recently placed suprarenal filter compatible with a hematoma without active extravasation.It was decided to keep the patient for hemodynamic monitoring and hold anticoagulation for 48 hours.Approximately two months post filter deployment, attempts to remove the filter were unsuccessful.Approximately three months post filter deployment, additional attempts to remove the filter were unsuccessful due to angulation of the filter apex with the hook embedded in the wall of the ivc.No further information is noted regarding the patient¿s current status.Investigation summary: the device was not returned for evaluation and images were not returned for evaluation.However, medical records were provided and reviewed.Approximately two months post filter deployment, an attempt was made to retrieve the filter using multiple wires, catheters, balloons and snares without success.Approximately three months post filter deployment, multiple attempts to snare the filter were made; however, the hook of the filter could not be engaged due to angulation of the filter apex with the hook embedded in the wall of the ivc.At that point laparoscopic forceps were advanced and again, multiple attempts to retrieve the filter were made, but the apex of the filter could not be successfully engaged or displaced from the ivc wall.The suprarenal filter was left in place with the hook angled toward the wall of the ivc with malpositioned legs.Therefore, based on the provided medical records, the investigation is confirmed for a tilted filter and difficulties removing the filter resulting in the filter remaining implanted.Per the provided medical records, the tilted filter was not identified until the second filter retrieval attempt.The tilted filter most likely contributed to the retrieval difficulties.The first retrieval attempt could have contributed to the filter becoming tilted.Additionally, per the provided medical records, the filter was reportedly implanted suprarenal.The ifu states, "the safety and effectiveness of this device has not been established for pregnancy, nor in the suprarenal placement position." therefore, the position of the filter could have contributed to the alleged deficiencies.However, the definitive root cause is unknown.Labeling review:the current ifu (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 precautions: the safety and effectiveness of this device has not been established for pregnancy, nor in suprarenal position potential complications: movement, migration or tilt of the filter are known complications of vena cava filters.Filter tilt, filter malposition.

Event Description

It was reported through the litigation process that a vena cava filter was placed after being diagnosed with deep vein thrombosis/pulmonary embolism.Some time post filter deployment, the filter allegedly tilt and embedded in the wall of the ivc; after two unsuccessful removal procedures, the filter was successfully removed percutaneously.The patient allegedly experienced bleeding and was hospitalized.

• 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 ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 7150116
• MDR Text Key: 95896767
• Report Number: 2020394-2017-01821
• 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: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MD800J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization
• Patient Age: 56 YR
• Patient Weight: 91