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

Model Number DL900F

Device Problems Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problems Abdominal Pain (1685); Chest Pain (1776)

Event Date 07/19/2017

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.(expiry date: 05/2019).

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 migrated, struts perforated and detached.The device and the detached struts has not been removed and there were no reported attempts made to retrieve the filter.The detached strut retained in the right lower lobe within the pulmonary artery.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.After four days, lung ventilation/perfusion study was performed for pleuritic chest pain.The study showed intermediate probability for pulmonary embolus.X-ray chest was performed which showed inferior vena cava filter was in place.After two months, patient presented with the complaints of chest pain and abdominal pain.Ultrasound abdomen was performed and unremarkable.After two days, a bilateral lower limb venous duplex study was performed for lower extremity swelling, which showed no evidence of deep venous thrombosis.After two months, patient presented with the complaints of abdominal pain and chest pain.Computed tomography of chest was performed, which showed negative for pulmonary embolism.On the next day, an ultrasound abdomen was performed to check for thrombus.The study showed retro hepatic inferior vena cava are patent with normal flow.After four months, patient presented with the complaints of shortness of breath, chest pain and worsening abdominal pain.X-ray chest was performed for chest pain, which showed partially visualized inferior vena cava filter.The filter was fractured, and a single strut of the filter was embolized and presumably within the middle lobe pulmonary artery branch.Computed tomography angiography of chest was performed on the same day for chest pain, which showed negative for pulmonary embolism and there was a linear radiopaque structure possibly representing a retained catheter fragment within the segmental pulmonary artery branch serving the medial aspect of the right middle lobe.After one week, patient presented with the complaints of chest pain and shortness of breath.X-ray chest was performed for chest pain, which showed a foreign body likely fractured inferior vena cava filter strut, within the branch of right pulmonary artery.After two weeks, patient presented with the complaints of vomiting, diarrhea and fever.Ultrasound abdomen was performed for right upper quadrant abdominal pain.The study showed non-occlusive thrombus was noted on the main and left portal veins.On the next day, a computed tomography of abdomen was performed for abdominal pain, which showed partially occlusive thrombus in the superior mesenteric vein.After one month, patient presented with the complaints of fever and abdominal pain.X-ray chest was performed, which showed linear wire density noted to be in the pulmonary artery of the right middle lobe.A computed tomography of abdomen was performed for abdominal pain, which showed that the infrarenal inferior vena cava filter was demonstrated with possible penetration of the struts.The thrombus present previously in the superior mesenteric vein and portal vein has improved with less filling defect.After five days, a magnetic resonance imaging of abdomen was performed which showed inferior vena cava filter was in place.On the next day, x-ray abdomen was performed which showed inferior vena cava filter was present at the level of l2.After ten days, a computed tomography of abdomen was performed for diffuse abdominal pain.The study showed that stable positioning of infrarenal inferior vena cava filter.X-ray chest was performed for chest pain, which showed partially visualized inferior vena cava filter.Therefore, the investigation is confirmed for alleged filter limb detachment and perforation of the inferior vena cava.However, the investigation is inconclusive for alleged filter migration.Based on 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: d4 (expiry date: 05/2019), g3.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.At some time post filter deployment, it was alleged that filter migrated, struts perforated and detached.The device and the detached struts has not been removed and there were no reported attempts made to retrieve the filter.The detached strut retained in the right lower lobe within the pulmonary artery.The current status of the patient is unknown.

• Brand Name: DENALI FEMORAL SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11700292
• MDR Text Key: 246469713
• Report Number: 2020394-2021-80355
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• PMA/PMN Number: K130366
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFAR3088
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACETAMINOPHEN, ALBUTEROL AND CAPSAICIN; ACETAMINOPHEN, ALBUTEROL AND CAPSAICIN; CYANOCOBALAMIN, CYCLOBENZAPRINE AND ENOXAPARIN; CYANOCOBALAMIN, CYCLOBENZAPRINE AND ENOXAPARIN; FAMOTIDINE, FLUTICASONE, FUROSEMIDE AND INSULIN; FAMOTIDINE, FLUTICASONE, FUROSEMIDE AND INSULIN; LOSARTAN, MESALAMINE ER AND METOPROLOL; LOSARTAN, MESALAMINE ER AND METOPROLOL; MULTIVITAMIN, POLYETHYLENE GLYCOL AND PREDNISONE; MULTIVITAMIN, POLYETHYLENE GLYCOL AND PREDNISONE; PROGRAF, PROMETHAZINE AND SPIRONOLACTONE; PROGRAF, PROMETHAZINE AND SPIRONOLACTONE; TERAZOSIN, TRAMADOL, URSODIOL AND VITAMIN D3; TERAZOSIN, TRAMADOL, URSODIOL AND VITAMIN D3; ACETAMINOPHEN, ALBUTEROL AND CAPSAICIN; CYANOCOBALAMIN, CYCLOBENZAPRINE AND ENOXAPARIN; FAMOTIDINE, FLUTICASONE, FUROSEMIDE AND INSULIN; LOSARTAN, MESALAMINE ER AND METOPROLOL; MULTIVITAMIN, POLYETHYLENE GLYCOL AND PREDNISONE; PROGRAF, PROMETHAZINE AND SPIRONOLACTONE; TERAZOSIN, TRAMADOL, URSODIOL AND VITAMIN D3
• Patient Outcome(s): Other
• Patient Age: 60 YR