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

Catalog Number DL950J

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Perforation of Vessels (2135)

Event Date 03/22/2022

Event Type  Injury  

Event Description

It was reported that approximately nine days after the vena cava filter placement, ct examination allegedly revealed that a leg of the filter was abnormal.It was further reported that the filter could not be removed via the jugular and the femoral approach, but only the detached leg segment was removed by a snare.Patient reportedly had vessel wall embedded with the filter hook and the legs penetrated the right renal vein.The current status of the patient is unknown.

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 been returned to the manufacture for evaluation.However, images were provided for review.The investigation of the reported event is currently underway.The catalog number identified has not been cleared in the us but is similar to the denali filter product that are cleared in the us.The pro code and 510 k number for the denali filter product are identified.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali filter product that are cleared in the us.The pro code and 510 k number for the denali filter product are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one detached filter extension leg was returned for evaluation.Although the partial sample was returned, seven x-ray images were provided and reviewed.The one initial filter placement x-ray was showing a vena cava filter with the proximal aspect at the l1 vertebral body.The filter legs that were visualized appear intact and the image reflects a normal appearing filter with the understanding that not all the legs can be perfectly visualized due to poor image quality.Remaining six x-ray images centered along the spine shows a severely tilted/displaced filter due to a filter leg abnormality.At least one of the filter legs appears abnormally bent.The exact location along the spine cannot be determined from the images.Based on the findings, the investigation is confirmed for the reported filter limb detachment, material deformation and the identified filter tilt issues.However, the investigation is inconclusive for the reported difficult to remove issue.A definitive root cause for the reported filter limb detachment, material deformation, difficult to remove, and the identified filter tilt issues could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f ¿ the information provide by bd represents all 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 that approximately nine days after the vena cava filter placement, ct examination allegedly revealed that a leg of the filter was abnormal.It was further reported that the filter could not be removed via the jugular and the femoral approach, but only the detached leg segment was removed by a snare.Patient reportedly had vessel wall embedded with the filter hook and the legs penetrated the right renal vein.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali filter product that are cleared in the us.The pro code and 510 k number for the denali filter product are identified in d2 and g4.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one retrieved denali filter with one leg missing and the detached filter limb separately were returned for evaluation.Although the sample was returned, seven x-ray images were provided and reviewed.The one initial filter placement x-ray was showing a vena cava filter with the proximal aspect at the l1 vertebral body.The filter legs that were visualized appear intact and the image reflects a normal appearing filter with the understanding that not all the legs can be perfectly visualized due to poor image quality.Remaining six x-ray images centered along the spine shows a severely tilted/displaced filter due to a filter leg abnormality.At least one of the filter legs appears abnormally bent.The exact location along the spine cannot be determined from the images.Based on the findings, the investigation is confirmed for the reported filter limb detachment, material deformation and the identified filter tilt issues.However, the investigation is inconclusive for the reported difficult to remove issue.A definitive root cause for the reported filter limb detachment, material deformation, difficult to remove, and the identified filter tilt issues could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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 that approximately nine days after the vena cava filter placement, ct examination allegedly revealed that a leg of the filter was abnormal.It was further reported that the filter could not be removed via the jugular and the femoral approach, but only the detached leg segment was removed by a snare.Patient reportedly had vessel wall embedded with the filter hook and the legs penetrated the right renal vein.The current status of the patient is unknown.

Manufacturer Narrative

H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the denali filter product that are cleared in the us.The pro code and 510 k number for the denali filter product are identified in d2 and g4.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one retrieved denali filter with one leg missing and the detached filter limb separately were returned for evaluation.The detached cranial leg along with the filter were examined under the microscope.The proximal end of the detached leg aligned with the distal segment of the main filter at the point of detachment.Although the sample was returned, seven x-ray images were provided and reviewed.The one initial filter placement x-ray was showing a vena cava filter with the proximal aspect at the l1 vertebral body.The filter legs that were visualized appear intact and the image reflects a normal appearing filter with the understanding that not all the legs can be perfectly visualized due to poor image quality.Remaining six x-ray images, centered along the spine shows a severely tilted/displaced filter due to a filter leg abnormality.At least one of the filter legs appears abnormally bent.The exact location along the spine cannot be determined from the images.Based on the findings, the investigation is confirmed for the reported filter limb detachment, material deformation and the identified filter tilt issues.However, the investigation is inconclusive for the reported difficult to remove issue.A definitive root cause for the reported filter limb detachment, material deformation, difficult to remove, and the identified filter tilt issues could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 12/2022), g3, h6 (method).H11: b5, d4 (medical device lot).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 that approximately nine days after the vena cava filter placement, ct examination allegedly revealed that some limbs of the filter was bent or deformed.It was further reported that the filter could not be removed via the jugular and the femoral approach, but only the detached leg segment was removed by a snare.Reportedly , the filter was retrieved through a sheath so the condition of the limbs may be attributed to retrieval through the sheath.Patient had vessel wall embedded and the legs penetrated the right renal vein.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
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 14135081
• MDR Text Key: 289432508
• Report Number: 2020394-2022-00299
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 00801741040818
• UDI-Public: (01)00801741040818
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/31/2022

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 Catalogue Number: DL950J
• Device Lot Number: GFEN1424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/18/2022
• Supplement Dates Manufacturer Received: 05/05/2022; 08/10/2022; 10/19/2022
• Supplement Dates FDA Received: 05/07/2022; 08/19/2022; 11/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2020
• 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): Required Intervention
• Patient Age: 21 YR
• Patient Sex: Female