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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - FEMORAL VENA CAVA FILTER Back to Search Results
Catalog Number RF310F
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Malposition of Device (2616); Detachment of Device or Device Component (2907); Material Protrusion/Extrusion (2979)
Patient Problems Pulmonary Embolism (1498); Great Vessel Perforation (2152); No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Event Date 06/12/2009
Event Type  Injury  
Manufacturer Narrative

The device has not been returned, and no medical images have been made available to the manufacturer. A manufacturing review is currently being performed. The investigation of the reported event is currently underway. Based on the medical records received: patient had an ivc filter successfully deployed for a history of dvt and failed anticoagulation therapy. Approximately three days post filter deployment, a ct scan demonstrated a strut of the filter projecting posterior to the aorta, and what appeared to be two other struts outside of the lumen of the ivc. Approximately four months post filter deployment, attempted filter retrieval was unsuccessful. Imaging demonstrated filter tilt with the cone abutting the right lateral wall. Approximately three years post filter deployment, a ct scan demonstrated an abnormal filter axis, a detached strut in the left lower lobe pulmonary arterial branch and a detached strut in the right ventricle. A cardiac doppler study demonstrated no evidence of a foreign body in the right heart chambers. The patient was seen by a hcp for complaints of pain and shortness of breath. The hcp reviewed previous imaging that demonstrated a detached filter leg within the left lower lobe pulmonary artery, a detached filter leg within the right ventricle and a detached filter leg adjacent to the filter. Review of a previous echo and cardiac doppler demonstrated no metal filament within the right ventricle. The hcp stated that the removal of the filter would be best for pain relief and avoidance of future filter migration and fragmentation. The hcp stated that the fragment within the left lower lobe pulmonary artery should be stable, and risk of removing it would outweigh potential benefits. An attempt was made to retrieve the foreign body in the ivc. Imaging demonstrated two detached filter limbs within the ivc at the level of the filter. The detached limbs were not retrieved. The patient had a consultation for filter retrieval. Review of previous imaging demonstrated the filter tip embedded along the right caval wall, two filter legs protruding in the retroaortic space, one component extending anteriorly towards the bowel and one detached component extending along the posterior caval wall. The hcp stated: filter retrieval is desired in order to help alleviate pain from component penetration; any old fragments that have embolized would be left alone; and any newly embolized pieces of the filter would be removed if identified during the procedure. Scout imaging demonstrated: rightward deviation of the filter hook; detachment of three arms and one leg of the filter; one detached arm in the left lower lung field; one detached arm and leg in the region of the ivc at the level of the filter; one of the six arms of the filter are not identified. Imaging further demonstrated penetration of at least two legs and two arms medially outside of the ivc lumen. The following day the filter was retrieved successfully by blunt tissue dissection with rigid forceps. Attempts were made to remove the two detached filter limbs that had perforated the ivc wall unsuccessfully. Imaging demonstrated stability of two previously detached filter limbs in the retroperitoneum, and one previously detached filter limb in a subsegmental branch of the left pulmonary artery. Patient was reported to be hemodynamically stable. 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 approximately three days post vena cava filter deployment, ct scan demonstrated a filter limb perforating the posterior ivc wall. Approximately four months post vena cava filter deployment, an attempt to retrieve the filter was unsuccessful. Guided fluoroscopy demonstrated the filter was tilted with the apex against the ivc wall. The retrieval device was unable to capture and retrieve the vena cava filter. Approximately three years post vena cava filter deployment, an unsuccessful attempt was made to retrieve the vena cava filter. Guided fluoroscopy demonstrated two detached filter limbs protruding into the retroperitoneal space. As well as one detached limb extending along the posterior ivc wall. A snare device was unable to capture and retrieve the detached filter limbs. Approximately two months following the second unsuccessful filter retrieval attempt, the filter was retrieved successfully by blunt tissue dissection with rigid forceps to capture and retrieve the vena cava filter. Additional attempts were made with the forceps to remove the two detached filter limbs that had perforated the ivc wall near the retroperitoneum unsuccessfully. Guided fluoroscopy indicated the detached filter limbs were in stable position. Patient was reported to be hemodynamically stable at the conclusion the procedure. No other reported attempts have been made to remove the detached limbs.

 
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. 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: as medical images were not provided, a review could not be performed. Conclusion: the medical records allege that the filter was tilted with the apex against the ivc wall. Several struts were allegedly perforating through the ivc wall. An unsuccessful retrieval attempt was allegedly performed approximately 7 weeks after implantation. The patient allegedly delivered a full term baby via c-section. Allegedly a ct scan demonstrated two broken struts, one in the left lower pulmonary lobe and the other in the right ventricle. The filter was successfully removed approximately 51 months after implantation. Three arms and one leg were reportedly detached. Two limbs were reportedly outside the ivc lumen in stable positions. One limb was reportedly in the lower left lung field and the fourth limb was not visualized. Based on the medical records, filter tilt, perforation of the ivc, an unsuccessful retrieval attempt, and limb detachment can be confirmed. The filter was likely difficult to remove if the filter was tilted and the apex was embedded in the ivc wall. It is unknown why the filter became tilted and perforated the ivc wall. It is possible the patient's pregnancy affected the stability of the filter which caused the limbs to detach. It is also possible that some of the limbs detached during the initial attempts to remove the filter. However, the definitive root cause 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. Movement, migration or tilt of the filter are known complications of vena cava filters. - potential complications: procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to, the following: perforation or other acute or chronic damage of the ivc wall. Filter tilt. Filter malposition. 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.

 
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Brand NameG2 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 Key5278506
MDR Text Key33060589
Report Number2020394-2015-01988
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK062887
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
Report Date 07/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/09/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2011
Device Catalogue NumberRF310F
Device LOT NumberGFSJ2342
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/19/2008
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: 12/09/2015 Patient Sequence Number: 1
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