• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD PERIPHERAL VASCULAR, INC. VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN FILTER
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2019
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.After sometimes post deployment, the patient presented with back pain.On the same day, an x-ray spine lumbar minimum 4 views showed that a vena cava filter was noted.After six years and two months, a computed tomography (ct) abdomen and pelvis without contrast demonstrated that an inferior vena cava filter was seen.The tip of the inferior vena cava filter was seen in the middle part of the inferior vena cava and just inferior to the right renal vein.Penetration of the leads of the inferior vena cava filter was noted to the surrounding fat, the penetration measured 9 mm.One of the anterior leads penetrated to the duodenal wall.Therefore, the investigation is confirmed for the alleged 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.H10: g2,g3,h6(method, conclusion).H11: b5,h6(device, result).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 after being diagnosed with unknown medical complication.At some time post filter deployment, a computed tomography (ct) abdomen and pelvis without contrast revealed that the filter struts penetrated to the duodenal wall.The device has not been removed and there were no reported attempts made to retrieve the filter.The patient reportedly expired.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10231581
MDR Text Key197537567
Report Number2020394-2020-04223
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 09/24/2021
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 Catalogue NumberUNKNOWN FILTER
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/16/2020
Initial Date FDA Received07/06/2020
Supplement Dates Manufacturer Received09/20/2021
Supplement Dates FDA Received09/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
LIORESAL, BETHANECHOL AND GABAPENTIN; TAMSULOSIN AND ACETAMINOPHEN-HYDROCODONE
Patient Outcome(s) Death;
Patient Age64 YR
Patient Weight81
-
-