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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. DENALI FILTER SYSTEM; VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. DENALI FILTER SYSTEM; VENA CAVA FILTER Back to Search Results
Catalog Number UNK DENALI
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  Death  
Manufacturer Narrative
Manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were not provided.The investigation is inconclusive 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.
 
Event Description
It was reported through the litigation process that some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
 
Manufacturer Narrative
H10: manufacturing review: the device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Post-deployment, x-ray of abdomen was performed which revealed there was an inferior vena cava filter in good position.Around, nineteen days later, computed tomography of abdomen and pelvis without contrast was performed which revealed an inferior vena cava filter.Around one year and ten months later, peripheral venogram was performed for acute thrombosis of bilateral lower extremities extending into inferior vena cava and inferior vena cava filter.Venogram showed bilateral popliteal veins with runoff to the mid femoral vein which became occluded with thrombus in the mid segment with no collateral flow or reconstitution above this.An advantage glidewire and a 0.035 quick-cross catheter was wired across the thrombotic occlusion up through the inferior vena cava filter and placed ekosonic endovascular system catheters throughout bilateral femoral veins extending up into the inferior vena cava through the filter.There were no device deficiencies identified within the medical records.Therefore, the investigation is inconclusive 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.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 some time post vena cava filter deployment the patient expired.There was no specific device malfunction reported that may or may not have caused or contributed to the patient¿s death.The cause of the patient¿s death was not provided.No other pertinent patient, device or medical information was provided leading up to or surrounding the event.
 
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Brand Name
DENALI FILTER SYSTEM
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10238154
MDR Text Key197730173
Report Number2020394-2020-04302
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
K130366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 10/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNK DENALI
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received09/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACTOS, ASPIRIN, OMEPRAZOLE, REQUIP; CLONAZEPAM, BUPROPION, PRAVASTATIN, FISH OIL; HYDROCODONE, METHADONE, LISINOPRIL, METFORMIN; LANTUS AND XARELTO
Patient Outcome(s) Death;
Patient Weight91
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