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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. ECLIPSE FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number EC500F
Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Extrusion (2934)
Patient Problems Abdominal Pain (1685); Nausea (1970); Scarring (2061); Vomiting (2144); Great Vessel Perforation (2152); Obstruction/Occlusion (2422)
Event Date 04/25/2013
Event Type  Injury  
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only event reported to date for this lot number and failure mode. 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 vena cava filter was indicated prophylactically for trauma and a contraindication to anticoagulation. The filter was successfully deployed in a straight position at the l2-l3 level without incident. Two days post filter deployment, a kub demonstrated a tilted filter with caudal migration to the l4 interspace level. The vascular surgeon was not notified about this finding. The patient developed abdominal pain and distention, nausea, vomiting and had severe constipation with no bowel movement recorded since hospital admission. Five days post filter deployment, a ct scan demonstrated a closed loop small-bowel obstruction and two filter limbs perforating through the ivc wall: one limb in proximity to the duodenum and one limb adjacent to the right iliac artery. The patient underwent exploratory laparotomy. A midline incision was made about 2 cm below the umbilicus to 3. 5 cm above the umbilicus. Two points of obstruction within the small bowel were identified and the adhesions were lysed. The small bowel was brought up and visualized and there was no evidence of any injury or perforation; however, it appeared that a filter limb had come through the small bowel mesentery most likely acting as a nidus for the closed loop obstruction. There was no gross evidence of any leakage within the peritoneal cavity. Of concern was the fact that the filter limb may have poked into the small bowel, however, it is of such a small diameter that it was difficult to make sure whether or not it had gone full thickness through the small bowel. It appeared that the 2nd filter limb was protruding into the third portion of the duodenum. It was difficult to say whether this was transmural or if it was just subserosal. The filter limb was removed, and an egd demonstrated no bubbling and no evidence of any leakage. Next, the vena cava was dissected and clamped proximally and distally, and a 5-0 pursestring suture was placed just above where the hook of the filter could be felt. An incision was made within the pursestring suture, and a clamp pushed down on the caval wall to extrude out the hook and tip of the filter. A snare device successfully pulled out the filter. The extruded filter limbs were cut off with wire cutters; one with 2-3 cm segment exposed and the other with about 1 cm exposed. The filter was inspected, and there was no evidence of any detached limbs. There were no other problems with the ivc noted. The patient tolerated the procedure well and was transferred to the recovery room in stable condition. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the medical records allege a kub and ct scan demonstrated filter tilt, caudal migration, and perforation of the ivc as well as a small bowl obstruction. Surgery was performed to remove the filter and clear the obstruction. The investigation is confirmed for filter tilt, caudal migration, and limb perforation. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal migration of the filter. Migration may be caused by placement in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu. Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens. Perforation or other acute or chronic damage of the ivc wall. Infection, filter malposition, filter tilt, organ injury, pain. All of the above complications may be associated with serious adverse events such as medical intervention and/or death. (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 provided. The patient status at this time is unknown. New information received: it was reported by the patient that a vena cava filter was deployed in conjunction with trauma situation/motor vehicle accident. After an unknown amount of time post filter deployment, two filter limbs allegedly perforated the vena cava causing a closed loop small bowel obstruction. An open exploratory laparotomy was performed to remove the filter. The patient allegedly experienced pain, infection at the surgical site, a scar and scar tissue. Based on a review of the medical records received, it was reported that a vena cava filter was successfully deployed prophylactically at the l2-l3 level for trauma and a contraindication to anticoagulation. Two days post filter deployment, the patient presented with constipation, abdominal pain, abdominal distention, nausea and vomiting. A kub demonstrated a tilted filter with caudal migration to the l4 interspace level. Five days post filter deployment, a ct scan demonstrated a closed loop bowel obstruction and two limbs perforating the ivc wall adjacent to the duodenum and the iliac artery. An exploratory laparotomy with lysis of small bowel adhesions was performed and the filter was successfully extracted from the vena cava with a snare device. There was no extravasation identified. The patient was hemodynamically stable at the conclusion of the procedure. No additional information was provided in medical records received.
 
Manufacturer Narrative
Manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process and quality control testing. This lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only event reported to date for this lot number and failure mode. 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: a request was made for vena cava filter placement for pulmonary embolus prophylaxis due to risk of deep vein thrombosis and pulmonary embolism; as there was the anticipation of further surgeries, a prolonged term of recovery and immobility and the contradiction to anticoagulation. Access was gained to the right common femoral vein and a venacavagram demonstrated the location of the renal veins, adequate caval size and the ivc without thrombus. The filter was successfully deployed in a straight position at the l2-l3 level without incident. The patient was hemodynamically stable at the conclusion of the procedure. Two days post filter deployment, a kub was performed for complaints of left lower quadrant pain. This demonstrated a tilted filter with caudal migration to the l4 interspace level. The vascular surgeon was not notified about this finding. The patient had developed abdominal pain and distention, and had severe constipation with no bowel movement recorded since hospital admission. Four days post filter deployment, a ct scan demonstrated a closed loop small-bowel obstruction and two filter limbs perforating through the ivc wall: one limb in proximity to the duodenum and one limb adjacent to the right iliac artery. The next day, the patient underwent a surgical procedure for the small bowel obstruction and to remove the filter. The abdomen was prepped in usual sterile fashion. A midline incision was made about 2 cm below the umbilicus to 3. 5 cm above the umbilicus. Serous ascites were drained after entering the peritoneal cavity. Exploration of the abdomen showed some dilated loops of small bowel with no evidence of any ischemic changes. Two points of obstruction within the small bowel were identified and the adhesions were lysed. The small bowel was brought up and visualized and there was no evidence of any injury or perforation; however, it appeared that a filter limb had come through the small bowel mesentery most likely acting as a nidus for the closed loop obstruction. There was no gross evidence of any leakage within the peritoneal cavity. Of concern was the fact that the filter limb may have poked into the small bowel, however, it was of such a small diameter that it was difficult to make sure whether or not it had gone full thickness through the small bowel. Next, the right colon was mobilized and the duodenum was kocherized and brought up to visualize the ivc. It appeared that the second filter limb was protruding into the third portion of the duodenum. It was difficult to say whether this was transmural or if it was just subserosal. The filter limb was removed, and an egd demonstrated no bubbling and no evidence of any leakage. Attention was turned to removal of the filter. The vena cava was dissected and clamped proximally and distally, and a 5-0 pursestring suture was placed just above where the hook of the filter could be felt. An incision was made within the pursestring suture, and a clamp pushed down on the caval wall to extrude out the hook and tip of the filter. A snare device successfully pulled out the filter. The extruded filter limbs were cut off with wire cutters; one with 2-3 cm segment exposed and the other with about 1 cm exposed. The filter was inspected, and there was no evidence of any detached limbs. The pursestring suture was enough to secure the hemostasis and there was good hemostasis around the ivc. There were no other problems with the ivc noted. There was no other arterial venous injury evident throughout the inspected region. The initial small bowel loop that was mobilized from the anterior adhesion also had no evidence of injury. A drain was placed and the rest of the small bowel and the right colon were placed back into the peritoneal cavity. Hemostasis was checked and the fascia was closed. Instrument and lap pack counts were reported correctly x 2. The patient tolerated the procedure well and transferred to the recovery room in stable condition. Twelve days later, the patient was discharged to a rehabilitation hospital in stable condition. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: the medical records allege a kub and ct scan demonstrated filter tilt, caudal migration, and perforation of the ivc as well as a small bowl obstruction. Surgery was performed to remove the filter and clear the obstruction. The investigation is confirmed for filter tilt, caudal migration, and limb perforation. Based upon the available information, the definitive root cause is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: movement, migration or tilt of the filter are known complications of vena cava filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal migration of the filter. Migration may be caused by placement in ivcs with diameters exceeding the appropriate labeled dimensions specified in this ifu. Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens. Perforation or other acute or chronic damage of the ivc wall. Infection. Filter malposition. Filter tilt. Organ injury. Pain. All of the above complications may be associated with serious adverse events such as medical intervention and/or death. (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 provided. The patient status at this time is unknown. New information received: it was reported by the patient that a vena cava filter was deployed in conjunction with trauma situation/motor vehicle accident. After an unknown amount of time post filter deployment, two filter limbs allegedly perforated the vena cava causing a closed loop small bowel obstruction. An open exploratory laparotomy was performed to remove the filter. The patient allegedly experienced pain, infection at the surgical site, a scar and scar tissue. Medical records were received and reviewed. The vena cava filter was successfully deployed prophylactically at the l2-l3 level for trauma and a contraindication to anticoagulation. Two days post filter deployment, the patient presented with constipation, abdominal pain, abdominal distention, nausea and vomiting. A kub demonstrated a tilted filter with caudal migration to the l4 interspace level. Four days post filter deployment, a ct scan demonstrated a closed loop bowel obstruction and two limbs perforating the ivc wall adjacent to the duodenum and the iliac artery. An exploratory laparotomy with lysis of small bowel adhesions was performed and the filter was successfully extracted from the vena cava with a snare device. There was no extravasation identified and the patient was hemodynamically stable at the conclusion of the procedure.
 
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Brand NameECLIPSE FILTER SYSTEM - FEMORAL
Type of DeviceVENA CAVA FILTER
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
C.R. BARD, INC. (GFO)
289 bay road
queensbury NY 12804
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key5730149
MDR Text Key47552102
Report Number2020394-2016-00553
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 02/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2015
Device Catalogue NumberEC500F
Device Lot NumberGFWK2802
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/12/2012
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: 06/16/2016 Patient Sequence Number: 1
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