MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL; VENA CAVA FILTER

Catalog Number RF310F

Device Problems Detachment of Device or Device Component (2907); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Great Vessel Perforation (2152); Blood Loss (2597); 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.Medical record review: a patient with a history of bilateral pulmonary emboli and bilateral deep vein thrombosis despite therapeutic anticoagulation had a vena cava filter deployed above the level of the renal veins.Approximately six years nine months post filter deployment, the patient presented to the emergency department with right upper quadrant and epigastric abdominal pain and vomiting and was admitted to the hospital.The patient underwent an esophagogastroduodenoscopy (egd) procedure, where the patient was diagnosed with an unspecific hemorrhage of the gastrointestinal tract and ulcer.A ct scan of the abdomen was performed, which demonstrated multiple ivc filter strut fractures with embolization throughout the body.There was no perforated viscus or acute bleeding.There had been previous discussion with interventional radiology regarding retrieval of the filter struts versus continued monitoring and a plan was made to conference with vascular surgery.Approximately three days post hospital admission, the patient was discharged.Investigation summary: the device was not returned for evaluation.However, images and medical records were provided for review.Approximately six years and nine months post filter deployment, ct scan of the abdomen was performed, which demonstrated multiple ivc filter strut fractures with embolization throughout the body.There was no perforated viscus or acute bleeding.Images provided were of the esophageal procedure and did not demonstrate the implanted filter.Therefore, based on the provided information, the investigation can be confirmed for detached filter limbs.The investigation is inconclusive for the alleged perforation.Per the provided medical records, the filter was deployed in the suprarenal location.Per the instructions for use (ifu), "the safety and effectiveness of this device has not been established for pregnancy, nor in the suprarenal placement position." therefore, patient factors could have contributed to the alleged deficiencies.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters.There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.Perforation or other acute or chronic damage of the ivc wall.Precaution: the safety and effectiveness of this device has not been established for pregnancy, nor in the suprarenal placement position procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications.Complications may occur at any time during or after the procedure.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 in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that filter limbs detached and perforated.The filter has not been removed.The patient allegedly experienced bleeding.The current patient status was not provided.

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.Photos and medical records were provided and reviewed.The photos did not have any clinical correlation or relevant to the filter complaint.Therefore, the investigation is inconclusive based on provided photos as no objective evidence is provided for any alleged deficiency.Based on the medical records, approximately seven years post filter deployment, patient presented with abdominal pain.Subsequently, computed tomography revealed multiple inferior vena cava filter strut fractures with embolization throughout body.Approximately two years later, computed tomography.An embolized inferior vena cava filter strut in the right lower lobe lateral basilar segmental artery.Computed tomography revealed some of the struts of the inferior vena cava filter were extending into the right renal vein and upper pole of the right kidney and detached strut medial to the kidney.Approximately two years later, computed tomography revealed inferior vena cava filter was within a suprarenal location with status extending posteriorly outside the inferior vena cava m1 strut extending into the right anterior kidney approximately 1 cm.Approximately one month later, patient presented for filter retrieval.Right renal angiography was performed, and 10 struts were noted o the inferior vena cava filter with additional 2 fractured struts in the abdomen and a 3rd fractured strut in the lower right peripheral pulmonary artery.There were unable to retrieve.The filter with all 10 intact struts were retrieved.Based on the medical records, the investigation is confirmed for perforation of the ivc and filter limb detachment.Therefore, the investigation is confirmed for perforation of the ivc and filter limb detachment.Labeling review: ifu: warnings: if large thrombus is demonstrated at the initial delivery site, do not attempt to deliver the filter through it as migration of the clot and/or filter may occur.Attempt filter delivery through an alternate site.A small thrombus may be bypassed by the guidewire and introducer catheter.Precautions: the filter should be placed in the suprarenal position in pregnant women and in women of childbearing age.H10: b2, b5, b6, g4, h6 (patient: (b)(6)).H11: h6 (method, result, conclusion).H11:section a through f - 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 in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism.At some time post filter deployment, it was alleged that filter limbs detached and perforated.The device was removed percutaneously.It was further reported that the detached struts remained in patient.The patient reportedly experienced bleeding and abdominal pain; however, the current status of the patient is unknown.

• Brand Name: G2 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: 7239000
• MDR Text Key: 98963304
• Report Number: 2020394-2018-00049
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K062887
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2011
• Device Catalogue Number: RF310F
• Device Lot Number: GFSD2833
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOVENOX, XARELTO; LOVENOX, XARELTO
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 48 YR
• Patient Weight: 75