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

Catalog Number RF310F

Device Problems Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems Abdominal Pain (1685); Pseudoaneurysm (2605)

Event Date 07/06/2016

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately nine years and five months post filter deployment, patient presented with abdominal pain.Subsequently, it was noted that there was perforation of the filter out of the inferior vena cava.There are prongs extending posteriorly and a large right renal pseudoaneurysm which was at least 3 to 4 cm in diameter and caused by the filter perforation.Dissection continued medially from the retroperitoneum.The duodenum was mobilized medially and with a kocher maneuver.As the duodenum was elevated off of the vena cava, the struts from the filter were visible and were poking into the duodenum anteriorly.Other struts were jutting into the retroperitoneum.The strut penetrating the third portion of the duodenum was removed with gentle traction and it left a defect in the serosa.There appeared to be some mucosa on the distal end of the strut where a hook was located.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter limb detachment.Based upon 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 spinal cord transection secondary to gunshot wound with paraplegia.At some time post filter deployment, it was alleged that the filter struts perforated and detached.The device was removed via an open abdominal procedure.The detached struts has not been removed after an attempted but unsuccessful open abdominal procedure.The patient was diagnosed with pseudoaneurysm; however, the current status of the patient is unknown.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient for spinal cord transection secondary to gunshot wound with paraplegia.At some time post filter deployment, it was alleged that the filter struts perforated and detached.The device was removed via an open abdominal procedure.The detached struts has not been removed after an attempted but unsuccessful open abdominal procedure.The patient was diagnosed with pseudoaneurysm; however, the current status of the patient is unknown.

Manufacturer Narrative

H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately nine years and five months post filter deployment, the patient was presented with abdominal pain and a computed tomography (ct) abdomen and pelvis with contrast was performed and it revealed that the filter appeared tilted and was at least partially within the right renal vein.Subsequently, it was noted that there was perforation of the filter out of the inferior vena cava.There are prongs extending posteriorly and a large right renal pseudoaneurysm which was at least 3 to 4 cm in diameter and caused by the filter perforation.Dissection continued medially from the retroperitoneum.The duodenum was mobilized medially and with a kocher maneuver.As the duodenum was elevated off of the vena cava, the struts from the filter were visible and were poking into the duodenum anteriorly.Other struts were jutting into the retroperitoneum.The strut penetrating the third portion of the duodenum was removed with gentle traction and it left a defect in the serosa.There appeared to be some mucosa on the distal end of the strut where a hook was located.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter limb detachment.Based upon 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.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 - FEMORAL
• 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: 10506534
• MDR Text Key: 206091244
• Report Number: 2020394-2020-05596
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062887
• 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
• Report Date: 04/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF310F
• Device Lot Number: GFQL0345
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/07/2022
• 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 Outcome(s): Required Intervention; Other
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Race: Black Or African American