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Catalog Number RF048F
Device Problems Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Extrusion (2934)
Patient Problems Abdominal Pain (1685); Great Vessel Perforation (2152); Bowel Perforation (2668)
Event Date 10/18/2011
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: a manufacturing review could not be conducted as the lot number was not provided. Visual/microscopic inspection: as the device was not returned, an inspection could not be performed. Functional/performance evaluation: as the device was not returned, an evaluation could not be performed. Medical records review: the patient with multiple lower extremity fractures resulting from trauma was scheduled for vena cava filter placement. The right groin was prepped in sterile fashion. The common femoral vein was accessed and the vena caval filter delivery sheath was introduced. Inferior venacavography was performed to size the cava and evaluate the position of renal veins and iliac venous confluence. There was no evidence of vena caval thrombus and the caval anatomy was classical. The filter was deployed in the infrarenal ivc without complication. The delivery sheath was removed and hemostasis was achieved with direct pressure. The patient tolerated the procedure well and was returned to the hospital ward in stable condition. Approximately five years eight months post deployment the patient presented to the vascular surgery clinic with abdominal pain and early satiety and the ivc filter was found to be eroding into the duodenum. Vascular surgery consulted general surgery for removal of the ivc filter and repair of the duodenum. The patient was taken to the operating theater where primary exposure was done by general surgery. Vascular surgery then further mobilized the duodenum sharply off the anteromedial surface of the vena cava. The first filter limb came in from the anterior surface of the vena cava and was associated with a frank hole in the vena cava. The limb was divided and the hole in the vena cava was repaired with a 5-0 non-absorbable suture. One limb laterally was retracted and divided and dissection was carried medially. Two limbs appearing to go into the pancreas were also withdrawn and divided without any further bleeding. Finally, one limb with the hook was seen to be lodged in the duodenum. This was divided and the end of the duodenum was removed and then the end going more centrally was divided. There was no further bleeding visible and there were no further stretch visible on the anterior 270 degrees of the vena cava. The ivc filter was removed and inferior vena cava repaired. General surgery then proceeded with fixing five areas of protrusion into the duodenum, performing extensive lysis of adhesions and placement of an omental flap over the duodenal injury. A jp drain was placed and the procedure was completed. The patient tolerated the procedure well. She was then transferred to the post anesthesia care unit and then transferred to the floor for further management. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the device was not returned. Images were not provided. Medical records were provided and reviewed. A vena cava filter was successfully deployed. Five years and eight months post filter deployment, the patient presented with pain. It was found that two filter limbs were perforating the ivc wall and two appeared to be perforating the pancreas. One limb with the hook was seen to be lodged in the duodenum. Surgery was conducted to remove the limbs and filter along with repair. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: potential complications: possible complications include but are not limited to the following: - perforation of other acute or chronic damage of the ivc wall. (b)(4). The information provided by bard 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 bard.
Event Description
It was reported that a vena cava filter was deployed successfully, the reason for the filter deployment was not provided. No alleged deficiency with the device was reported. No other information regarding this event was received. Patient status was not provided. New information received: medical records were received and reviewed. Approximately five years eight months post vena cava filter deployment secondary to trauma, the patient experienced abdominal pain and early satiety. The ivc filter was found to have multiple limbs perforating the pancreas and eroding into the duodenum. Exploratory laparotomy, extensive lysis of adhesions, removal of the ivc filter with repair of the ivc and duodenum were performed. The patient tolerated the procedure well and was discharged in stable condition. No additional medical records were received for this patient.
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Manufacturer (Section D)
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1415 w. 3rd street
tempe, AZ 85281
MDR Report Key6174415
MDR Text Key62369652
Report Number2020394-2016-01174
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRF048F
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2016 Patient Sequence Number: 1