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

Model Number DL900F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Extrusion (2934); Material Deformation (2976); Positioning Problem (3009)

Patient Problems Hematoma (1884); Great Vessel Perforation (2152)

Event Date 10/10/2013

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.Medical records review: the patient with history of deep vein thrombosis and inability to anticoagulate was scheduled for inferior vena cava (ivc) filter placement.The right common femoral vein was accessed and a venogram demonstrated the level of the renal veins.During deployment, the filter became severely tilted to the patient's right side.Multiple unsuccessful attempts were made to straighten the filter.The right internal jugular vein was accessed and the filter was grasped with a snare device.The filter resisted repositioning efforts.The snare portion of a retrieval device broke off onto one of the legs of the filter.Multiple attempts to reposition the filter from above and below were unsuccessful.Inferior venacavogram demonstrated the filter oriented in a transverse position at the level of the renal veins with some of the legs oriented superiorly.The wires and catheters were removed.Approximately three days post filter placement, physician's note stated the filter was being watched by serial imaging and noted an ivc leak and retroperitoneal hematoma.The patient denied any complaints.Vascular surgery recommended against surgical intervention due to low platelet count.The patient was transferred to the intensive care unit for closer monitoring.Approximately two weeks post filter deployment, chest x-ray demonstrated an ivc filter within the right mid abdomen at a transverse lie with an additional linear metallic density associated with it.Approximately three years two months post filter deployment, the patient died.Immediate cause of death was respiratory arrest due to acquired immunodeficiency syndrome.Other significant conditions were asthma, human immunodeficiency virus and encephalopathy.Investigation summary: the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.Based on the medical records, the investigation is confirmed for tilted filter.However, the investigation is inconclusive for perforation as it is unknown whether the filter caused ivc leak.Additionally, the investigation is also inconclusive for material deformation.Per the medical record, the filter tilted during deployment.However, the definitive root cause is unknown.Labeling review: the current ifu (instructions for use) states: warnings/potential complications: - movement, migration or tilt of the filter are known complications of vena cava filters.- perforation or other acute or chronic damage of the ivc wall.- filter tilt.- filter malposition.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.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 some time post filter deployment, it was alleged that the filter tilted.The device has not been removed and there were no reported attempts made to retrieve the filter.Approximately three years and one month post filter deployment the patient expired.

Event Description

It was reported through the litigation process some time post filter deployment, it was alleged that the filter tilted.The device has not been removed and there were no reported attempts made to retrieve the filter.Approximately three years and one month post filter deployment the patient expired.

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.Medical records were provided and reviewed.During deployment the filter became severely tilted to the patient¿s right side.Multiple attempts were made to manipulate the filter to straighten it, but these were unsuccessful.The filter was grasped with the snare device, however the filter resisted all efforts at repositioning.The snare portion of a retrieval device broke off onto one of the legs of the filter.Multiple attempts were made to reposition the filter from above and from below all of which were unsuccessful.Then an inferior vena cavogram was performed which demonstrated the filter was oriented in a transverse direction.Post deployment study showed percutaneous filter placement with severe tilt and unsuccessful repositioning of the filter.A computer tomography showed that the filter was in a transverse position at the level of the renal veins with some of the legs oriented superiorly.Approximately twelve days post deployment, an addendum to hospital course mentioned the filter was malpositioned.The next day, an x-ray of chest showed that the filter was within the right mid abdomen at a transverse lie with an additional linear metallic density associated with it.Around four days later, an x-ray of chest showed the filter in a transverse lie.Around one month later, the discharge summary of the patient mentioned that the patient had a complicated deep vein thrombosis status post misplaced filter, however the filter was stable at this point.Therefore, the investigation is confirmed for filter tilt and positioning problem.However, the investigation is inconclusive for material deformation and perforation of ivc.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.

• 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
• 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: 7410116
• MDR Text Key: 104801006
• Report Number: 2020394-2018-00362
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130366
• 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
• Report Date: 04/12/2022

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 Expiration Date: 07/31/2015
• Device Model Number: DL900F
• Device Catalogue Number: DL900F
• Device Lot Number: GFXE3411
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/05/2022
• Supplement Dates FDA Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2013
• 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: ATOVAQUONE, ATRIPLA, REMERON, METAMUCIL; ATOVAQUONE, ATRIPLA, REMERON, METAMUCIL; VALGANCICLOVIR, COUMADIN, TRAZODONE, COMPAZINE; VALGANCICLOVIR, COUMADIN, TRAZODONE, COMPAZINE; ZOFRAN, TYLENOL, MULTIVITAMIN; ZOFRAN, TYLENOL, MULTIVITAMIN
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 57 KG