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

Catalog Number RF048F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Pain (1994); Cardiac Perforation (2513)

Event Date 08/19/2016

Event Type  Injury  

Manufacturer Narrative

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.

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 and morbid obesity.Approximately eleven years and two months post filter deployment, it was alleged that the filter perforated the abdominal aorta and one limb extends anterior to the l3.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient 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.Approximately eleven years and two months of post deployment, a computed tomography abdomen was performed, demonstrating positive evidence of grade 3 perforation with the right ventrolateral strut abutting duodenum about 11 mm.Inferior vena cava filter was noted around mid l2 to inferior l3 with no presence of migration and significant tilt.Computerized tomography- angiogram of the chest, abdomen, and pelvis without then with contrast was performed which demonstrated that an infra renal inferior vena cava filter was present 2 the inferomedial limbs of the filter appeared to extend beyond the lumen of the inferior vena cava, one limb extends anterior to the infra renal aorta, and one limb extends anterior to the l3 inferior endplate.Around four days later, computerized tomography angiogram images showed that an inferior vena cava filter present with a tilt to the side slightly, to of the limbs of the filter extending on the lumen of the inferior vena cava with one limb extending anterior to the infra renal aorta in one limits in the anterior to the l3 inferior end plate, no definite thrombus was seen below the inferior vena cava or within the pelvic vein, 9 mm thyroid nodule.Around two months later, the patient had chest pain and the workup involved a computerized tomography abdomen that demonstrated the inferior vena cava filter was tilted with leg penetration out of the inferior vena cava.Around one month later, computerized tomography abdomen without contrast showed that an inferior vena cava filter was present in position in the infra renal inferior vena cava.The cephalad margin was moderately tipped to the patient's right.One tine at approximately the 3:00 position projects extraluminal by up to 7 mm and abuts the anterior margin of the aorta.No retroperitoneal hematoma.On axial image and sagittal image there was a curvilinear metallic density projecting within the anterior margin of the right ventricle.This linear metallic structure extends through ventricular myocardium, through the pericardial space, through the pericardium and minimally into the right epicardial fat.That was most in keeping with a fractured and migrated fragment/tine of the patient's inferior vena cava filter.Around two months later, the patient reported to have an inferior vena cava filter that broken apart and there was a piece that went to the heart, stomach, and spine.Around four months later, the patient who apparently has a chronically fractured inferior vena cava filter in the body that has been recommended to be removed.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter tilt and filter limb detachment.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.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 after being diagnosed with deep vein thrombosis/pulmonary embolism and morbid obesity.Approximately eleven years and two months post filter deployment, it was alleged that the filter struts perforated the abdominal aorta and one limb extends anterior to the l3.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 12481229
• MDR Text Key: 271695350
• Report Number: 2020394-2021-80720
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K031328
• 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: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF048F
• Device Lot Number: GFPA0425
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALBUTEROL, CLINDAMYCIN, NALOXONE; ALBUTEROL, CLINDAMYCIN, NALOXONE; AZITHROMYCIN, BACLOFEN, BUPROPION, VITAMIN D; AZITHROMYCIN, BACLOFEN, BUPROPION, VITAMIN D; GABAPENTIN, OXYBUTYNIN, HYDROCODONE-ACETAMINOPHEN; GABAPENTIN, OXYBUTYNIN, HYDROCODONE-ACETAMINOPHEN; NEXIUM, LEVOTHYROXINE, TOPIRAMATE, ACETAMINOPHEN; NEXIUM, LEVOTHYROXINE, TOPIRAMATE, ACETAMINOPHEN; PHENERGAN, MSCONTIN, ZANAFLEX; PHENERGAN, MSCONTIN, ZANAFLEX; PROMETHAZINE, OXYBUTYNIN, MORPHINE, ROPINIROLE; PROMETHAZINE, OXYBUTYNIN, MORPHINE, ROPINIROLE; VITAMIN D3, FETZIMA, TIZANIDINE; VITAMIN D3, FETZIMA, TIZANIDINE; ALBUTEROL, CLINDAMYCIN, NALOXONE; AZITHROMYCIN, BACLOFEN, BUPROPION, VITAMIN D; GABAPENTIN, OXYBUTYNIN, HYDROCODONE-ACETAMINOPHEN; NEXIUM, LEVOTHYROXINE, TOPIRAMATE, ACETAMINOPHEN; PHENERGAN, MSCONTIN, ZANAFLEX; PROMETHAZINE, OXYBUTYNIN, MORPHINE, ROPINIROLE; VITAMIN D3, FETZIMA, TIZANIDINE
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 172