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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. MERIDIAN FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number MD800F
Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395); Malposition of Device (2616); Detachment of Device or Device Component (2907)
Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 01/24/2013
Event Type  Injury  
Manufacturer Narrative

No medical images have been made available to the manufacturer. As the lot number for the device was not provided, a review of the device history records cannot be performed. The device has not been returned to the manufacturer for evaluation. The investigation of the reported event is currently underway. Medical records were received and reviewed. Patient was involved in a motor vehicle accident (mva). Multiple traumas inflicted to the patient included pelvic fractures, femur fracture, facial fractures, epidural hematoma, immobility and intubation. An ivc filter was deployed successfully in an upright position for protection of pulmonary emboli. Approximately five months post vena cava filter deployment, filter retrieval was scheduled. A vena cava gram was performed and a small foreign fragment was identified superior to the filter. After successful removal of the filter, the foreign fragment remained embedded in the ivc wall. Additionally, a spot fluoroscopic image of the chest revealed a small fragment of the filter embedded distally in a branch of the pulmonary artery. An additional procedure was performed at a later date to successfully retrieve the foreign fragment from the wall of the ivc. Patient was hemodynamically stable.

 
Event Description

It was reported that a vena cava filter was deployed successfully in an upright position in the ivc for protection of pe due to a mva. Approximately five months post deployment of the ivc filter, it was determined that the filter should be removed as the patient no longer required the device. A vena cava gram performed identified a well-seated infrarenal ivc filter with no thrombus present in the ivc. A snare device was used to successfully capture and retrieve the filter, upon successful removal of the filter, a second vena cava gram revealed a small foreign body in the ivc wall. Additionally, a spot fluoroscopic image of the chest revealed a small fragment of the filter embedded distally in a branch of the pulmonary artery, no attempt was made to remove the foreign body in the pulmonary artery. An open surgical approach was not advisable. An additional procedure was scheduled, a snare device was used to successfully removed the fragment from the ivc wall.

 
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. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: neither the device nor images were returned. Medical records were provided. The medical records allege a meridian filter was deployed for protection against pulmonary embolism due to a motor vehicle accident. Approximately five an a half months later, a venacavagram allegedly identified a small foreign body, presumably a filter limb, superior to the filter. The filter was allegedly retrieved successfully. Spot imaging of the chest allegedly demonstrated a second fragment overlying the right lung. Allegedly the fragment in the ivc was retrieved successfully during a second percutaneous procedure. Based on the medical record review, the investigation is confirmed for two detached filter limbs. Based upon the available information the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: - warnings: filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.

 
Manufacturer Narrative

No device and no images have been made available to the manufacturer. As the lot number for the device has not been provided, a review of the device history records could not be performed. Medical records were previously received and reviewed and the investigation of additional information regarding the reported event is currently underway. 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 was involved in a motor vehicle accident (mva). Multiple traumas inflicted to the patient included pelvic fractures, femur fracture, facial fractures, epidural hematoma, immobility and intubation. An ivc filter was deployed successfully in an upright position for protection of pulmonary emboli. Approximately five months post vena cava filter deployment, filter retrieval was scheduled. A vena cava gram was performed and a small foreign fragment was identified superior to the filter. After successful removal of the filter, the foreign fragment remained embedded in the ivc wall. Additionally, a spot fluoroscopic image of the chest revealed a small fragment of the filter embedded distally in a branch of the pulmonary artery. An additional procedure was performed at a later date to successfully retrieve the foreign fragment from the wall of the ivc. Patient was hemodynamically stable. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: neither the device nor images were returned. Medical records were provided. The medical records allege a meridian filter was deployed for protection against pulmonary embolism due to a motor vehicle accident. Approximately five an a half months later, a venocavagram allegedly identified a small foreign body, presumably a filter limb, superior to the filter. The filter was allegedly retrieved successfully. Spot imaging of the chest allegedly demonstrated a second fragment overlying the right lung. Allegedly the fragment in the ivc was retrieved successfully during a second percutaneous procedure. Based on the medical record review, the investigation is confirmed for two detached filter limbs. Based upon the available information the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques. 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 in an upright position in the ivc for protection of pe due to a mva. Approximately five months post deployment of the ivc filter, it was determined that the filter should be removed as the patient no longer required the device. A vena cava gram performed identified a well-seated infrarenal ivc filter with no thrombus present in the ivc. A snare device was used to successfully capture and retrieve the filter, upon successful removal of the filter, a second vena cava gram revealed a small foreign body in the ivc wall. Additionally, a spot fluoroscopic image of the chest revealed a small fragment of the filter embedded distally in a branch of the pulmonary artery, no attempt was made to remove the foreign body in the pulmonary artery. An open surgical approach was not advisable. An additional procedure was scheduled, a snare device was used to successfully removed the fragment from the ivc wall. New information received: it was reported that approximately five months post vena cava filter deployment, the patient allegedly experienced significant physical injuries as a result of the following events: the filter embedded, migrated, tilted, detached, perforated and/or otherwise became irretrievable. No additional information was provided.

 
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: patient was involved in a motor vehicle accident (mva). Multiple traumas inflicted to the patient included pelvic fractures, femur fracture, facial fractures, epidural hematoma, immobility and intubation. An ivc filter was deployed successfully in an upright position for protection of pulmonary emboli. Approximately five months post vena cava filter deployment, filter retrieval was scheduled. A vena cava gram was performed and a small foreign fragment was identified superior to the filter. After successful removal of the filter, the foreign fragment remained embedded in the ivc wall. Additionally, a spot fluoroscopic image of the chest revealed a small fragment of the filter embedded distally in a branch of the pulmonary artery. An additional procedure was performed at a later date to successfully retrieve the foreign fragment from the wall of the ivc. Patient was hemodynamically stable at the conclusion of the procedure. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: neither the device nor images were returned. Medical records were provided. The medical records allege a meridian filter was deployed for protection against pulmonary embolism due to a motor vehicle accident. Approximately five an a half months later, a venocavagram allegedly identified a small foreign body, presumably a filter limb, superior to the filter. The filter was allegedly retrieved successfully. Spot imaging of the chest allegedly demonstrated a second fragment overlying the right lung. Allegedly the fragment in the ivc was retrieved successfully during a second percutaneous procedure. There is no mention of migration, perforation or tilt in the medical records. Based on the medical record review, the investigation is confirmed for two detached filter limbs and unconfirmed for being irretrievable. The investigation is inconclusive for migration, perforation and tilt. Based upon the available information the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques movement, migration or tilt of the filter are known complications of vena cava filters. Perforation or other acute or chronic damage of the ivc wall. Acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessels. Filter tilt. Filter malposition. Note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. (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 in an upright position in the ivc for protection of pe due to a mva. Approximately five months post deployment of the ivc filter, it was determined that the filter should be removed as the patient no longer required the device. A vena cava gram performed identified a well-seated infrarenal ivc filter with no thrombus present in the ivc. A snare device was used to successfully capture and retrieve the filter, upon successful removal of the filter, a second vena cava gram revealed a small foreign body in the ivc wall. Additionally, a spot fluoroscopic image of the chest revealed a small fragment of the filter embedded distally in a branch of the pulmonary artery, no attempt was made to remove the foreign body in the pulmonary artery. An open surgical approach was not advisable. An additional procedure was scheduled, a snare device was used to successfully removed the fragment from the ivc wall. New information received: it was reported that approximately five months post vena cava filter deployment, the patient allegedly experienced significant physical injuries as a result of the following events: the filter embedded, migrated, tilted, detached, perforated and/or otherwise became irretrievable. No additional information was provided.

 
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 was involved in a mva; multiple traumas included pelvic fractures, femur fracture, facial fractures, epidural hematoma, immobility and intubation. A meridian ivc filter was deployed successfully in an upright position in the ivc for protection of pe. Approximately five months post deployment of the ivc filter, it was determined that the filter should be removed as the patient no longer required the device. A 5 fr pigtail catheter was positioned in the inferior vena cava and vena cava gram performed; this identified a well-seated infrarenal ivc filter with no thrombus present. Of note, a small foreign body presumed to present filter leg fragment was seen superior to the filter. After removal of the filter, a second vena cava gram revealed that the foreign fragment remained in the ivc wall. Additionally, a spot fluoroscopic image of the chest revealed a small fragment of the filter embedded distally in a branch of the pulmonary artery and is not retrievable via endovascular approach, and is not advisable to try to retrieve via open surgical approach. An additional procedure was scheduled. Performed fluoroscopic-guided retrieval of the foreign body and the fragment in the wall of the ivc was successfully removed. Pressure was held at the access site to achieve hemostasis. Image/photo review: no medical images have been made available to the manufacturer. Conclusion: neither the device nor images were returned. Medical records were provided. The medical records allege a meridian filter was deployed for protection against pulmonary embolism due to a motor vehicle accident. Approximately five an a half months later, a venocavagram allegedly identified a small foreign body, presumably a filter limb, superior to the filter. The filter was allegedly retrieved successfully. Spot imaging of the chest allegedly demonstrated a second fragment overlying the right lung. Allegedly the fragment in the ivc was retrieved successfully during a second percutaneous procedure. There is no mention of migration, perforation or tilt in the medical records. Based on the medical record review, the investigation is confirmed for two detached filter limbs and unconfirmed for being irretrievable. The investigation is inconclusive for migration, perforation and tilt. Based upon the available information the definitive root cause for this event is unknown. Labeling review: the current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques; movement, migration or tilt of the filter are known complications of vena cava filters; perforation or other acute or chronic damage of the ivc wall; acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessels; filter tilt; filter malposition; note: it is possible that complications such as those described in the "warnings", "precautions", or "potential complications" sections of this instructions for use may affect the recoverability of the device and result in the clinician's decision to have the device remain permanently implanted. (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 in an upright position in the ivc for protection of pe due to a mva. Approximately five months post deployment of the ivc filter, it was determined that the filter should be removed as the patient no longer required the device. A vena cava gram performed identified a well-seated infrarenal ivc filter with no thrombus present in the ivc. A snare device was used to successfully capture and retrieve the filter, upon successful removal of the filter, a second vena cava gram revealed a small foreign body in the ivc wall. Additionally, a spot fluoroscopic image of the chest revealed a small fragment of the filter embedded distally in a branch of the pulmonary artery, no attempt was made to remove the foreign body in the pulmonary artery. An open surgical approach was not advisable. An additional procedure was scheduled, a snare device was used to successfully removed the fragment from the ivc wall. New information received: it was reported that approximately five months post vena cava filter deployment, the patient allegedly experienced significant physical injuries as a result of the following events: the filter embedded, migrated, tilted, detached, perforated and/or otherwise became irretrievable. No additional information was provided. New information received: it was alleged that the patient will require monitoring of the detached filter limb remaining in the pulmonary artery every three months. No additional information was received.

 
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Brand NameMERIDIAN 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 Key5218471
MDR Text Key30990608
Report Number2020394-2015-01825
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK112497
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 02/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberMD800F
Device LOT NumberUNKNOWN
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 Received01/29/2018
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: 11/11/2015 Patient Sequence Number: 1
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