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

Model Number DL900J

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Extrusion (2934); Patient Device Interaction Problem (4001)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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: vena cava filter was placed secondary to deep venous thrombosis.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 of the ivc, tilt, and retrieval difficulties as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.Expiry date: 04/2017, manufacture date: 04/2014.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 in conjunction with or before bariatric procedure.Sometime post filter deployment it was alleged that the filter tilted and perforated the vena cava.The device was removed percutaneously after an attempted but unsuccessful retrieval attempt.The status of the patient is unknown.

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: vena cava filter was placed secondary to deep venous thrombosis.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 of the ivc, tilt, and retrieval difficulties as no objective evidence has been provided to confirm any alleged deficiency with the filter.Per the reported event details, the filter was placed prior to a bariatric procedure.Per the instructions for use (ifu), ¿the safety and effectiveness of this device has not been established for morbidly obese patients.Abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter.¿ however, the definitive root cause for perforation, tilt and removal difficulties are unknown.Labeling review: the current ifu (instructions for use) states: precautions: ¿the safety and effectiveness of this device has not been established for morbidly obese patients.Abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter.¿ 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: 04/2017), device manufacture date (04/2014).(device, method, conclusion).

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient in conjunction with or before bariatric procedure.Sometime post filter deployment it was alleged that the filter tilted and perforated the vena cava.The device was removed percutaneously after an attempted but unsuccessful retrieval attempt.The status of the patient is unknown.

• Brand Name: DENALI JUGULAR SYSTEM
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7651858
• MDR Text Key: 112857916
• Report Number: 2020394-2018-01029
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040795
• UDI-Public: (01)00801741040795
• 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: 08/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: GFYC3620
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1