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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 Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Material Deformation (2976)
Patient Problem Pain (1994)
Event Date 10/19/2018
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, ten years and five months of post deployment, the patient experienced abdominal pain.Around, three years three months later, x-ray of chest and lateral view was performed which showed the tip of an inferior vena cava filter was present at the inferior margin of the exam.Around, three months and twenty-three days later, the patient experienced low back pain.Around, two months and four days later, x-ray of lumbar spine was performed which showed one of the prongs of the inferior vena cava filter has become dislodged from the filter and extends slightly superior to the filter.The wound indicate that the prong has likely become embedded and attached to the inferior vena cava wall.Around, three months and six days later, the patient had acute abdominal pain, computed tomography of abdomen and pelvis with contrast was performed which showed prongs of inferior vena cava filter embedded in right ventricle.Inferior vena cava prongs otherwise penetrate and are seen outside confinement of the inferior vena cava.No associated clot or thrombosis.On the same day, x-ray of abdomen was performed which showed superior aspect of the inferior vena cava filter was at the inferior endplate of l2 vertebral body.On the same day, computed tomography of chest without contrast was performed which showed embedded inferior vena cava filter prong which was broken from the inferior vena cava filter.Partially visualized inferior vena cava filter was noted.On the next day, the patient experienced chest pain.After, three days, foreign body retrieval was performed which showed inferior vena cava tine removed in its entirety from the right ventricle via a right internal jugular vein approach without complication.Attention was then turned to retrieve the inferior vena cava filter.The filter appears to be a bard g2 filter on imaging.Using right internal jugular vein and right common femoral vein access points were able to free the filter but were unable to recover it into the 16 fr sheath as the distal tip of the right internal jugular vein sheath has folded in on itself.Of note a small 1-2 mm fragment belonging to the distal catheter tip of the bard 20 mm loop snare recovery system broke free from the catheter and was free floating in the right ventricle.Inferior vena cava filter was seen projecting over the t 12-l1.On the next day, complex inferior vena cava filter retrieval was performed for wound which showed filter had five tines protruding beyond inferior vena cava with two into the duodenal wall and one tine which eroded into an osteophyte at the inferior endplate of l3 and has broken off.An additional tine had broken off and wedged into the right ventricle which was retrieved.Patient complaints of abdominal and back pain.An attempt was made for inferior vena cava filter retrieval but was aborted as patient systolic blood pressure was into the 220's and required high doses of sedation.After, seven days, inferior vena cavogram was performed for inferior vena cava filter retrieval as the filter was currently not indicated and removal was warranted as the filter tines have been fracturing, which showed through the right internal jugular vein approach, a 0.035-inch wire was carefully advanced into the inferior vena cava well caudal to the filter.The sheath was then exchanged for a 14 french sheath.A 10 french bard cone recovery filter retrieval sheath was then placed telescopically through the 14 french sheath.The sheath was then positioned just above the filter tip.The recovery cone was advanced and deployed just above the central tip of the inferior vena cava filter.The filter had significant anterior tilt making difficult for the cone to retrieve the filter.Loop snare technique as well as endobronchial forceps were used to straighten out the filter.There were multiple attempts using different techniques to retrieve the filter (endobronchial forceps, loop snare technique and the bard retrieval cone).However, the procedure was aborted as were at 2.5gy for dose and procedure time approached over 2 hours.Inferior venacavography was performed to assess inferior vena cava integrity and confirm filter location in the intrahepatic inferior vena cava.The filter was in the intrahepatic inferior vena cava with significant tilt and could not be removed.The filter contains 10 tines as 2 had fractured prior to our retrieval attempt.Redemonstrated was the known tine which was lodged at the l3 vertebral body level.The other missing tine had been removed from the right ventricle at a prior visit.Post removal cavography shows no contrast extravasation or leak.The inferior vena cava was intact.Around, one month and five days later, inferior vena cavogram was performed for inferior vena cava filter removal with follow-up cavogram which showed the right internal jugular vein 12 french sheath was advanced near the tip of the filter and a bard cone filter retrieval device was advanced through the right internal jugular vein sheath and used to capture the filter.The filter was then withdrawn into the right internal jugular vein sheath and removed.Next, through the right common femoral vein sheath a snare was deployed and used to capture the fractured tine at the l3 vertebral body level.The tine was successfully snared and withdrawn through the right common femoral vein sheath.Post removal radiographs demonstrated no remaining fragments of the inferior vena cava filter within the abdomen and pelvis.Inferior venacavography was performed to assess inferior vena cava integrity after filter retrieval.The images were reviewed.No immediate complication occurred, and the patient was discharged from the angiography suite in satisfactory condition.Around, one month and twenty days later, inferior vena cava filter retrieval was performed for fractured inferior vena cava filter which showed successful removal of suprarenal inferior vena cava filter and successful removal of tine in the inferior vena cava at the l3 vertebral body level.Therefore, the investigation is confirmed for filter tilt, perforation of the inferior vena cava (ivc), material deformation, filter limb detachment and retrieval difficulties.The definitive root cause could not be determined based upon available 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.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 trauma.At some time, post filter deployment, it was alleged that the filter tilted, eroded, struts perforated, detached and the patient reportedly experienced acute abdominal pain, low back pain and chest pain.The device has been removed after an unsuccessful percutaneous removal procedure.The current status of the patient is unknown.
 
Event Description
It was reported through the litigation process that a vena cava filter was placed in a patient after being diagnosed with trauma.At some time, post filter deployment, it was alleged that the filter tilted, eroded, struts perforated, detached and the patient reportedly experienced acute abdominal pain, low back pain and chest pain.The device has been removed after an unsuccessful percutaneous removal procedure.The current status of the patient is unknown.
 
Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately, ten years and five months of post deployment, the patient experienced abdominal pain.Around, three years three months later, x-ray of chest and lateral view was performed which showed the tip of an inferior vena cava filter was present at the inferior margin of the exam.Around, three months and twenty-three days later, the patient experienced low back pain.Around, two months and four days later, x-ray of lumbar spine was performed which showed one of the prongs of the inferior vena cava filter has become dislodged from the filter and extends slightly superior to the filter.The wound indicate that the prong has likely become embedded and attached to the inferior vena cava wall.Around, three months and six days later, the patient had acute abdominal pain, computed tomography of abdomen and pelvis with contrast was performed which showed prongs of inferior vena cava filter embedded in right ventricle.Inferior vena cava prongs otherwise penetrate and are seen outside confinement of the inferior vena cava.No associated clot or thrombosis.On the same day, x-ray of abdomen was performed which showed superior aspect of the inferior vena cava filter was at the inferior endplate of l2 vertebral body.On the same day, computed tomography of chest without contrast was performed which showed embedded inferior vena cava filter prong which was broken from the inferior vena cava filter.Partially visualized inferior vena cava filter was noted.On the next day, the patient experienced chest pain.After, three days, foreign body retrieval was performed which showed inferior vena cava tine removed in its entirety from the right ventricle via a right internal jugular vein approach without complication.Attention was then turned to retrieve the inferior vena cava filter.The filter appears to be a bard g2 filter on imaging.Using right internal jugular vein and right common femoral vein access points were able to free the filter but were unable to recover it into the 16 fr sheath as the distal tip of the right internal jugular vein sheath has folded in on itself.Of note a small 1-2 mm fragment belonging to the distal catheter tip of the bard 20 mm loop snare recovery system broke free from the catheter and was free floating in the right ventricle.Inferior vena cava filter was seen projecting over the t 12-l1.On the next day, complex inferior vena cava filter retrieval was performed for wound which showed filter had five tines protruding beyond inferior vena cava with two into the duodenal wall and one tine which eroded into an osteophyte at the inferior endplate of l3 and has broken off.An additional tine had broken off and wedged into the right ventricle which was retrieved.Patient complaints of abdominal and back pain.An attempt was made for inferior vena cava filter retrieval but was aborted as patient systolic blood pressure was into the 220's and required high doses of sedation.After, seven days, inferior vena cavogram was performed for inferior vena cava filter retrieval as the filter was currently not indicated and removal was warranted as the filter tines have been fracturing, which showed through the right internal jugular vein approach, a 0.035-inch wire was carefully advanced into the inferior vena cava well caudal to the filter.The sheath was then exchanged for a 14 french sheath.A 10 french bard cone recovery filter retrieval sheath was then placed telescopically through the 14 french sheath.The sheath was then positioned just above the filter tip.The recovery cone was advanced and deployed just above the central tip of the inferior vena cava filter.The filter had significant anterior tilt making difficult for the cone to retrieve the filter.Loop snare technique as well as endobronchial forceps were used to straighten out the filter.There were multiple attempts using different techniques to retrieve the filter (endobronchial forceps, loop snare technique and the bard retrieval cone).However, the procedure was aborted as were at 2.5gy for dose and procedure time approached over 2 hours.Inferior vena cavography was performed to assess inferior vena cava integrity and confirm filter location in the intrahepatic inferior vena cava.The filter was in the intrahepatic inferior vena cava with significant tilt and could not be removed.The filter contains 10 tines as 2 had fractured prior to our retrieval attempt.Redemonstrated was the known tine which was lodged at the l3 vertebral body level.The other missing tine had been removed from the right ventricle at a prior visit.Post removal cavography shows no contrast extravasation or leak.The inferior vena cava was intact.Around, one month and five days later, inferior vena cavogram was performed for inferior vena cava filter removal with follow-up cavogram which showed the right internal jugular vein 12 french sheath was advanced near the tip of the filter and a bard cone filter retrieval device was advanced through the right internal jugular vein sheath and used to capture the filter.The filter was then withdrawn into the right internal jugular vein sheath and removed.Next, through the right common femoral vein sheath a snare was deployed and used to capture the fractured tine at the l3 vertebral body level.The tine was successfully snared and withdrawn through the right common femoral vein sheath.Post removal radiographs demonstrated no remaining fragments of the inferior vena cava filter within the abdomen and pelvis.Inferior vena cavography was performed to assess inferior vena cava integrity after filter retrieval.The images were reviewed.No immediate complication occurred, and the patient was discharged from the angiography suite in satisfactory condition.Around, one month and twenty days later, inferior vena cava filter retrieval was performed for fractured inferior vena cava filter which showed successful removal of suprarenal inferior vena cava filter and successful removal of tine in the inferior vena cava at the l3 vertebral body level.Therefore, the investigation is confirmed for filter tilt, perforation of the inferior vena cava (ivc), material deformation, filter limb detachment and retrieval difficulties.The definitive root cause could not be determined based upon available 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: d1, d4 (medical device catalog number).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.H3 other text: device not returned.
 
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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 Key12655883
MDR Text Key277116813
Report Number2020394-2021-01888
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup
Report Date 10/27/2021
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 09/21/2021
Initial Date FDA Received10/19/2021
Supplement Dates Manufacturer Received10/22/2021
Supplement Dates FDA Received10/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACYCLOVIR, ESTRADIOL, BELLADONNA, SIMVASTATIN.; ACYCLOVIR, ESTRADIOL, BELLADONNA.; DOXYCYCLINE HYCLATE, KETOROLAC, PHENAZOPYRIDINE.; KETOROLAC, PHENAZOPYRIDINE, LIDOCAINE.; LIDOCAINE, VERAPAMIL AND BENZONATATE.; OXYCODONE, ASPIRIN, DOXYCYCLINE HYCLATE.; POLYETHYLENE GLYCOL, ACETAMINOPHEN, METFORMIN.; POLYETHYLENE GLYCOL, ACETAMINOPHEN, METFORMIN.; QUETIAPINE, NICOTINE, OXYCODONE, ASPIRIN.; SIMVASTATIN, QUETIAPINE, NICOTINE.; VERAPAMIL AND BENZONATATE.; ACYCLOVIR, ESTRADIOL, BELLADONNA; KETOROLAC, PHENAZOPYRIDINE, LIDOCAINE; OXYCODONE, ASPIRIN, DOXYCYCLINE HYCLATE; POLYETHYLENE GLYCOL, ACETAMINOPHEN, METFORMIN; SIMVASTATIN, QUETIAPINE, NICOTINE; VERAPAMIL AND BENZONATATE
Patient Outcome(s) Other;
Patient Age59 YR
Patient Weight84
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