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

Model Number DL900F

Device Problems Patient-Device Incompatibility (2682); Extrusion (2934)

Patient Problems Abdominal Pain (1685); Hematoma (1884); Hemorrhage/Bleeding (1888); Great Vessel Perforation (2152); Blood Loss (2597)

Event Date 01/22/2015

Event Type  Injury  

Manufacturer Narrative

Medical records review: the patient with history of recurrent deep vein thrombosis in the lower extremities had an inferior vena cava (ivc) filter deployed below the level of the renal veins.Post deployment imaging demonstrated good positioning of the filter.Hemostasis was obtained at the conclusion of the procedure.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 complaint reported to date for this lot number and failure mode.Investigation summary:the device was not returned for evaluation.Images were not provided for review.Medical records were provided and reviewed.There was no specific deficiency alleged in the provided medical records.Therefore, the investigation is inconclusive for perforation as no objective evidence has been provided to confirm any alleged deficiency with the filter.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: 10/2017; device manufacture date: 10/2014.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; other reason(s) for implant: lupus nephritis, antiphospholipid antibody syndrome.At some time post filter deployment, it was alleged that the filter perforated the inferior vena cava, retroperitoneum, and l3 lower lumbar artery.The patient reportedly experienced abdominal, groin, and back pain, was hospitalized with retroperitoneal bleed, and underwent two exploratory laparotomies.The device has not been removed and there were no reported attempts made to retrieve the filter.The 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 seven days post deployment, the filter was noted to have punctured the inferior vena cava.The next day, the patient was found to have a large retroperitoneal hematoma.The next day, the filter was noted to have injured an adjacent lumbar artery in the retroperitoneum resulting in a large retroperitoneal hematoma.Therefore, the investigation is confirmed for perforation of inferior vena cava.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: b2, b6, b7, d4 (expiry date: 10/2017), g3.H11: e1 (complainant e-mail address), g1, h6 (patient, device, 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.

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 lupus nephritis, antiphospholipid antibody syndrome.At some time post filter deployment, it was alleged that the filter perforated the inferior vena cava, retroperitoneum, and l3 lower lumbar artery.The patient reportedly experienced abdominal, groin, and back pain, was hospitalized with retroperitoneal bleed, and underwent two exploratory laparotomies.The device has not been removed and there were no reported attempts made to retrieve the filter.The 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
• 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: 7601660
• MDR Text Key: 111067366
• Report Number: 2020394-2018-00867
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• 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: GFYI2721
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2022
• 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
• Patient Outcome(s): Hospitalization; Required Intervention; Other
• Patient Age: 38 YR
• Patient Sex: Male