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

Catalog Number RF320J

Device Problems Malposition of Device (2616); Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/16/2010

Event Type  malfunction  

Manufacturer Narrative

No medical images have been made available to the manufacturer.Medical records were provided and reviewed.As the lot number for the device was not provided, a review of the device history records will not be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical records review: the patient presented with a finding of extensive deep vein thrombosis (dvt) involving the entire right lower extremity (le) and was taken the same day for prophylactic inferior vena cava (ivc) filter placement prior to thrombectomy and thrombolysis.The right internal jugular vein was accessed and an inferior venacavogram was performed showing thrombus extending from the right common iliac vein into the ivc.The ivc more centrally was free of clot.The filter was advanced and deployed below the renal vein level.There was good centering of the filter and the legs expanded to the diameter of the cava.The patient tolerated the procedure well.Following the ivc filter placement, the patient underwent right le venous thrombectomy and thrombolysis with t-pa, and left le and iliac venogram which demonstrated a large amount of clot remaining.The following day, the right iliac vein was successfully stented to 14 mm with excellent resulting flow.The ivc filter was noted to have moved slightly more distally and was slightly tilted.Approximately four years post filter deployment, ivc filter removal was requested and authorization approved to schedule patient for procedure; however, no records were provided regarding a filter retrieval procedure.No further information was noted regarding the patient¿s current status.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

Medical records were received through the litigation process.The patient with deep vein thrombosis had a vena cava filter successfully deployed prior to thrombectomy and thrombolysis.The following day, a right lower extremity venogram demonstrated that the filter had moved slightly more distally and was also slightly tilted.The current patient status is unknown.

Manufacturer Narrative

Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown.Investigation summary: the device was not returned for evaluation and images were not provided for review.However, medical records were provided and reviewed.Approximately one day post filter deployment, during a lower extremity venogram, the filter was noted to have moved slightly more distally and was slightly tilted.Therefore, the investigation is confirmed for unintended movement and tilt based on the provided medical records.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.- filter malposition - filter tilt.

Event Description

Medical records were received through the litigation process.The patient with deep vein thrombosis had a vena cava filter successfully deployed prior to thrombectomy and thrombolysis.The following day, a right lower extremity venogram demonstrated that the filter had moved slightly more distally and was also slightly tilted.The current patient status is unknown.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• Type of Device: VENA 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 Key: 7148580
• MDR Text Key: 95848361
• Report Number: 2020394-2017-01810
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Attorney
• Type of Report: Initial,Followup
• Report Date: 01/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/27/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/18/2018
• 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 Sequence Number: 1
• Patient Age: 65 YR