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

Catalog Number RF320J

Device Problems Partial Blockage (1065); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Extrusion (2934); Migration (4003)

Patient Problems No Known Impact Or Consequence To Patient (2692); Thrombosis/Thrombus (4440)

Event Date 02/05/2012

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a manufacturing review was not performed 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: as medical records were not provided, a review could not be performed.Image/photo review: no medical images have been made available to the manufacturer.Conclusion: the investigation is inconclusive for the reported failures.Based upon the available information, the definitive root cause is unknown.Labeling review: rnf: the current ifu (instructions for use) states: warnings/potential complications: possible complications include but are not limited to the following: filter fracture is a known complication of vena cava filters.Movement or migration of the filter is a known complication.This may be caused by placement in the ivc's with diameters exceeding the appropriate labeled dimensions specified in the ifu.Perforation of other acute or chronic damage of the ivc wall.The current ifu (instructions for use) states: warnings/potential complications: filter fractures are a known complication of vena cava filters.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.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 approximately four years seven 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

H10: as the lot number for the device was provided, a review of the device history records will be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H11: b2,d1,d4,g1,h6(patient, device, method, result and conclusion).H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that approximately four years and seven months post vena cava filter deployment, the patient allegedly experienced significant physical injuries and the filter embedded, migrated, tilted, limb detached, perforated and/or otherwise became irretrievable.The current status of the patient is unknown.

Event Description

It was reported that approximately four years and seven months post vena cava filter deployment, the patient allegedly experienced significant physical injuries and the filter embedded, migrated, tilted, limb detached, perforated and/or otherwise became irretrievable.The current status of the patient is unknown.

Manufacturer Narrative

H10: 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.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately four years and seven months later, there is a thrombus extending from the left popliteal vein into the inferior vena cava filter.A venogram of left lower extremity was obtained.Little or no flow of blood was seen through the inferior vena cava.It has also revealed deep vein thrombosis from inside the inferior vena cava filter down through the left popliteal vein.Chronic thrombus was seen at the top of the inferior vena cava filter.Multiple aspirations of the thrombus through the top of the inferior vena cava filter were performed with 6~french envoy catheters as well as 5-french kumpe catheters to reduce the thrombus burden in inferior vena cava filter.Multiple attempts were made to retrieve the filter however, the filter would not move most likely secondary to tissue ingrowth.Flow remained poor through the filter despite significant efforts were taken to clear thrombus from above and below.Moderate residual filling defect was noted in the top of the filter most likely secondary to old thrombus or fibrotic tissue.The filter was unable to be removed secondary to tissue ingrowth.After one year and three months, a venogram was obtained demonstrating multiple areas of narrowing in the inferior vena cava, as well as the preexisting stents and at the location of previously placed inferior vena cava filter, which was approximately 3-4mm in diameter.A stent was placed in the common iliac vein at the point of narrowing underneath the aorta and a pamaz stent at the site of previously placed inferior vena cava filter and a self-expanding stent as stent placed already was unsatisfactory to push the filter to the side and maintain adequate lumen.A protege global positioning system stent was placed within the previously placed external iliac stent and up into his common iliac vein.At this point, a large sheath was then placed over the wire, past the inferior vena cava filter and a palmaz p5010 stent was loaded on to a balloon and deployed at the site of the filter.Therefore, the investigation is confirmed for the partial blockage and retrieval difficulties.However, the investigation is inconclusive for the alleged filter tilt, perforation of the inferior vena cava, filter migration and filter detachment.Additionally, it can be confirmed that the patient experienced thrombus above the filter post deployment.However, the relationship to the filter is unknown.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.H10: d4(expiry date: 03/2010), g3, h6(device, method).H11:section a through f - the information provided by bd 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 bd.

• 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 ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5816150
• MDR Text Key: 50292131
• Report Number: 2020394-2016-00714
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: GFRC0770
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/22/2016
• Supplement Dates Manufacturer Received: 10/26/2021; 12/15/2021
• Supplement Dates FDA Received: 11/25/2021; 12/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2007
• 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 Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male