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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER
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BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2018
Event Type  Death  
Manufacturer Narrative
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.Medical records were not provided.Therefore, the investigation is inconclusive as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based on 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
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.Post filter deployment, computed tomography images of abdomen revealed inferior vena cava filter with the superior tip just proximal to the right renal vein.There was 15 degree rightward angulation of the filter.An anterior strut projects beyond the confines of the inferior vena cava abutting the right gonadal vein.A left posterior strut projects beyond the confines of the superior vena cava and lies adjacent to the right posterolateral aspect of the aorta.No periaortic hematoma was noted to suggest aortic perforation.It was unclear if this strut lied adjacent to or within the wall of aorta.Numerous other struts project within the percival fat consistent with perforation but do not appear to involve adjacent structures.There were no non-contrast computed tomography findings of caval thrombosis.Therefore, the investigation is confirmed for perforation of inferior vena cava (ivc) and filter tilt.Based on 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.
 
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Brand Name
VENA CAVA FILTER
Type of Device
VENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
MDR Report Key10136978
MDR Text Key194592138
Report Number2020394-2020-03768
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 05/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNKNOWN FILTER
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received05/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age61 YR
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