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

Catalog Number MD800F

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Chest Pain (1776); Cardiac Tamponade (2226); Cardiac Perforation (2513); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); Pericardial Effusion (3271)

Event Date 10/12/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five years and four months post filter deployment, the patient presented with pericardial effusion and scheduled for the inferior vena cava filter retrieval.The filter was fractured with one locally retained arm in the ivc and two arms in the right ventricle.The filter was then dissected free of the ivc wall using endobronchial forceps in the jaws of life technique and it was removed successfully.Next the locally retained fragment was also removed using forceps.Then, attention was directed to the fractured fragments in the right ventricle.Subsequently, ventriculogram revealed, two filter struts in the antero inferior right ventricle.Multiple attempts were made to remove the foreign bodies with snares was unsuccessful.The filter was inspected and found to be removed in its entirely.Subsequent computer tomography revealed, inferior vena cava filter strut was imbedded in the apex of the rv septum.Therefore, the investigation is confirmed for the filter limb detachment.However, the investigation is inconclusive for the perforation of the ivc and retrieval difficulties.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.Expiry date: (05/2013).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.At some time post filter deployment, it was alleged that the filter struts were detached, perforated beyond the lumen of the inferior vena cava and embolized within the right ventricle.The device was removed percutaneously through complex filter removal using the jaws of life technique.The detached strut retained in right ventricle free wall was removed via an open chest procedure after an unsuccessful open chest procedural attempt.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 or before bariatric procedure.At some time post filter deployment, it was alleged that the filter struts were detached, perforated beyond the lumen of the inferior vena cava and embolized within the right ventricle.It was further reported that the health care provider was able to remove the filter and the fractured strut from the inferior vena cava (ivc) wall by jaw of life technique and forceps.After an unsuccessful attempt to remove two struts from right ventricle (rv) via snare, one strut removed from the rv wall, however, one strut remained in the apex of the septum.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five years and four months post filter deployment, the patient presented with pericardial effusion and scheduled for the inferior vena cava filter retrieval.The filter was fractured with one locally retained arm in the ivc and two arms in the right ventricle.The filter was then dissected free of the ivc wall using endobronchial forceps in the jaws of life technique and it was removed successfully.Next the locally retained fragment was also removed using forceps.Then, attention was directed to the fractured fragments in the right ventricle.Subsequently, ventriculogram revealed, two filter struts in the antero inferior right ventricle.Multiple attempts were made to remove the foreign bodies with snares was unsuccessful.The filter was inspected and found to be removed in its entirely.Subsequent computer tomography revealed, inferior vena cava filter strut was imbedded in the apex of the rv septum.Therefore, the investigation is confirmed for the filter limb detachment.However, the investigation is inconclusive for the perforation of the ivc and retrieval difficulties.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.H10: b5, d4(expiry date: 05/2013).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 or before bariatric procedure.At some time post filter deployment, it was alleged that the filter struts detached, nine filter struts extended inferiorly from the filter apex and perforated beyond the lumen of the ivc, including struts abutting the undersurface of the duodenum, the lateral aspect of the aorta, and the anterior aspect of the vertebral bodies.The device was removed percutaneously through complex filter removal using the jaws of life technique.Additionally two embolized ivc filter struts were located within the right ventricle.The detached strut retained in right ventricle free wall and the apex of the right ventricle septum were removed via an open chest procedure after an unsuccessful open chest procedure.The patient suffers from fissure on sternum due to the open chest removal surgery.The current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five years and four months post deployment, a computed tomography of chest showed that there were two curvilinear radiopaque opacities within the right ventricle.These were compatible with embolized fractured inferior vena cava filter struts.A computed tomography of abdomen and pelvis was also performed in the same day which there were fractured struts extended superiorly and leftward and appeared to be localized within the inferior vena cava lumen.The study also showed that a total of nine additional struts extended inferiorly from the filter apex and several of these struts demonstrated penetration beyond the lumen of the inferior vena cava, including struts abutted the undersurface of the duodenum, the lateral aspect of the aorta, and the anterior aspect of the vertebral bodies.The next day, through the right internal jugular vein approach, the filter was removed.The cavogram study showed the filter was fractured with one locally retained arm in the inferior vena cava and two arms in the right ventricle.The filter was then dissected free of the wall of the inferior vena cava using endobronchial forceps in the jaws of life technique and was removed successfully.Next the locally retained fragment was also removed using forceps.Post removal cavogram was performed which showed successful complex filter removal.A ventriculogram demonstrated two filter struts in the anteroinferior right ventricle and the septal fragment appeared to be fully encapsulated in tissue.Multiple unsuccessful attempts were made to remove the foreign bodies with snares.One of the two fragments of the filler could be palpated in the right ventricle.This was visually identified and extracted from the wall of the right ventricle, where it was deeply imbedded.The other fragment could not be identified.Around five days later, a computed tomography of chest showed a curvilinear radiopaque opacity near the right ventricular apex, in keeping with an embolized fractured filter strut.Two days later, computed tomography of chest showed that there was an approximately 3.5cm linear metallic density at the apex of the right ventricle.Therefore, the investigation is confirmed for filter limb detachment, perforation of inferior vena cava and retrieval difficulties.Per medical records, multiple attempts were made to engage the apex of the filter but were unsuccessful due to filter limb detachment and perforation of inferior vena cava.This could have contributed to the retrieval difficulties.However, 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.H10: b2, b6, b7, d4(expiry date: 05/2013), g3, h6(patient, 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 ¿ 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: 9932531
• MDR Text Key: 186732773
• Report Number: 2020394-2020-02445
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2022

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: MD800F
• Device Lot Number: GFWC3808
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/07/2020
• Supplement Dates Manufacturer Received: 05/29/2020; 02/08/2022
• Supplement Dates FDA Received: 06/25/2020; 03/09/2022
• 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
• Treatment: CALCIUM, CELEBREX, CLARITIN; GLUCOSAMINE CHONDROITIN, HYZAAR, VITAMIN B12; GUAIFENESIN, CLOBETASOL PROPIONATE, MELOXICAM; LOSARTAN HYDROCHLOROTHIAZIDE, FLEXERIL AND MUCINEX; VITAMIN C, VITAMIN D2, CYCLOBENZAPRINE
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White