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

Catalog Number	DL900F
Medical Device Problem Codes	Malposition of Device (2616); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately three years and seven months post filter deployment, a computed tomography of abdomen was performed for inferior vena cava filter check and left leg, and hip pain.The study showed inferior vena cava filter was properly positioned below the renal veins.The filter was tilted anteriorly with its cone lying on the posterior wall of the inferior vena cava.The legs of the filter have penetrated through the wall of the inferior vena cava into the pericaval/mesenteric fat.One of the legs is in contact with the anterior periosteum of a lumbar vertebra with chronic reactive changes which may indicate that it is possibly embedded.Therefore, the investigation is confirmed for the reported perforation of vena cava wall, filter tilt.A definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2015).H11: section a through f ¿ the information provided 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.H3 other text : device not returned.
Event or Problem Description
It was reported through the litigation process that a vena cava filter was deployed via right common femoral vein approach for a patient with high risk for deep vein thrombosis and unable to anti-coagulate secondary to intracranial bleeding.It was further reported that three years, six months and twenty-six days post filter deployment, the filter was allegedly tilted anteriorly with its cone lying on the posterior wall of the inferior vena cava.Furthermore, the filter struts had allegedly perforated the inferior vena cava into the pericaval/mesenteric fat and one of the legs was in contact with the anterior periosteum of a lumbar vertebra.Reportedly, the patient allegedly experienced hip pain.However, the current status of the patient was unknown.
Event or Problem Description
It was reported through the litigation process that a vena cava filter was deployed via right common femoral vein approach for a patient with high risk for deep vein thrombosis and unable to anti-coagulate secondary to intracranial bleeding.It was further reported that three years, six months and twenty-six days post filter deployment, the filter was allegedly tilted anteriorly with its cone lying on the posterior wall of the inferior vena cava.Furthermore, the filter struts had allegedly perforated the inferior vena cava into the pericaval/mesenteric fat and one of the legs was in contact with the anterior periosteum of a lumbar vertebra.Reportedly, the patient allegedly experienced hip pain.However, the current status of the patient was unknown.
Additional Manufacturer Narrative
Our firm received an fda email correspondence on (b)(6) 2024 from mdr data systems team, (b)(6) indicating that the information (specifically the unique device identifier (udi) information in section d) of the previously submitted fda form 3500a, was incorrect and a request was made to submit supplemental report(s) with the entire udi number including the di and pi fields, all numbers, letters, parentheses, and symbols in the ¿unique device identifier (udi) #¿ fields.This supplemental report is in response to that request.Udi related data quality updates only.D4: medical device expiration date- 12/31/2025.D4: udi- (b)(4).G4: k240257, k160866, k143208, k130366.

• Brand Name: DENALI FEMORAL SYSTEM
• Common Device Name: 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: 18299239
• Report Number: 2020394-2023-01216
• Device Sequence Number: 7160893
• Product Code: DTK
• UDI-Device Identifier: 00801741040801
• UDI-Public: (01)00801741040801(17)150531(10)GFXD3014
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K130366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: DL900F
• Device Lot Number: GFXD3014
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male