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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Catalog Number UNKNOWN G2
Device Problems Malposition of Device (2616); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)
Patient Problem Abdominal Pain (1685)
Event Date 09/18/2015
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: a device history record review could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were provided and reviewed. Post filter deployment, the patient was presented with abdominal pain. Subsequently eight months later, computed tomography (ct) revealed an inferior vena cava filter was noted with at least 4 of the struts appearing to have penetrated the walls of the vena cava for a depth of at least 2mm to 3mm. Eventually four months later, computed tomography (ct) revealed a vena cava filter was present with multiple struts extending through the wall of the vena cava by almost 5mm to 10mm although the pattern of extension and the location of the filter are stable when compared to previous study. Approximately one year and seven months later, patient presented with chronic diarrhea and left side abdominal cramping. Around one year and eleven months later, previous computed tomography (ct) was reviewed. It revealed, the patient¿s inferior vena cava filter was a bard /recovery retrievable filter positioned infrarenal at the level. The filter was tilted anteriorly and medially, with the filter apex in direct contact with the anterior caval wall. Only five of six primary struts are visible on the imaging provided. All 5 remaining primary filter struts and 5 out of the 6 secondary struts perforated the inferior vena cava wall. The perforating anterior struts impinge directly on overlying bowel, posterior struts imping on the underlying disc, medial struts lies near adjacent aorta and perforating lateral struts imping on the proximal right gonadal vein, right ureter, and right psoas muscle. As noted above, a primary strut was missing consistent with the strut fracture and embolization. The embolized or missing fragment was not apparent on the imaging provided. Therefore, the investigation is confirmed for the perforation of the ivc, filter tilt and filter limb detachment. Based on the available information, the definitive root cause is unknown. Labeling review: a review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.

 
Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient for bariatric surgery and wall hernia repair. At some time post filter deployment, it was alleged that the filter tilted within the ivc and five of the filter's six primary struts and five of six secondary struts were perforating the wall of the ivc into adjacent area and the sixth primary strut was detached. The device has not been removed and there were no reported attempts made to retrieve the filter. The detached strut retained in the body. The patient experienced constant pain in the area where the struts migrated; however, the current status of the patient is unknown.

 
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Brand NameG2 FILTER SYSTEM
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
1415 w. 3rd street
tempe, AZ 85281
4803032689
MDR Report Key10354615
MDR Text Key201347444
Report Number2020394-2020-05220
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKNOWN G2
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2020
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: 08/03/2020 Patient Sequence Number: 1
Treatment
ACETAMINOPHEN, ALPRAZOLAM, CYCLOBENZAPRINE; HYDRALAZINE, MAGNESIUM SULFATE, NITROGLYCERIN; METOPROLOL, POTASSIUM CHLORIDE, SODIUM CHLORIDE; PANTOPRAZOLE SODIUM, LEVOTHYROXINE, APIXABAN; PHOSPHORUS, POTASSIUM CHLORIDE, PROMETHAZINE; SODIUM CHLORIDE, ONDANSETRON AND ASPIRIN
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