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

Model Number DL900J

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problem Abdominal Pain (1685)

Event Date 10/04/2018

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be 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 in conjunction with or before orthopedic procedure and for unable to take anticoagulants.At some time post filter deployment, it was alleged that the filter migrated, tilted, struts perforated and embedded in wall of the inferior vena cava.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: a device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.The medical records included images.The image review was documented in the medical records.Medical records were provided and reviewed.Approximately eight months later, an x-ray abdomen anteroposterior showed that there was an inferior vena cava filter identified at approximately the l2 level.After four months, a computed tomography (ct) angiogram pulmonary with and without intravenous contrast showed that there was no evidence for pulmonary embolic disease.The tip of an inferior vena cava filter was noted.After one month, the patient reported to the hospital with unspecified abdominal pain and addison¿s disease.On the same day, a computed tomography (ct) abdomen and pelvis with intravenous contrast showed that an inferior vena cava filter was identified in standard position, without definite thrombus.No pathologic leg penetration of the filter was identified.After two years and ten months, the patient reported to the hospital with intermittent abdominal pain.On the same day, a computed tomography (ct) abdomen without contrast showed that there was slight posterior tilt of the tip of the filter.The inferior vena cava filter was slightly low-lying, located approximately 3 cm below the level of the highest left renal vein.Of the proximal peripheral struts, the projection scattered just beyond the inferior vena cava wall consistent with tissue embedment.Of the distal 6 peripheral struts, the struts located at the 9 o¿ clock and 11 o¿ clock positions had perforated the inferior vena cava with a fat plane noted between the tip of the strut in the inferior vena cava.The others projected at/just beyond the wall of the inferior vena cava consistent with tissue embedment.There was no strut fracture or bending vesicle.Therefore, the investigation is confirmed for alleged filter tilt, filter migration, and perforation of the 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.H11: h6(results, 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 in conjunction with or before orthopedic procedure and for unable to take anticoagulants.At some time post filter deployment, it was alleged that the filter migrated, tilted, struts perforated and embedded in wall of the inferior vena cava.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: 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: 10941048
• MDR Text Key: 219362437
• Report Number: 2020394-2020-06468
• 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: 01/06/2021

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 Model Number: DL900J
• Device Catalogue Number: DL900J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 12/10/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR