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

Catalog Number RF400F

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

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 eleven months post filter deployment for a patient with right leg deep vein thrombosis and contraindications to anticoagulation, computed tomography of the abdomen and pelvis without contrast revealed several filter legs projected beyond the wall of the inferior vena cava with one leg abutted the duodenum and the other contacted the right lateral wall of the abdominal aorta.After three years and seven months, computed tomography of the abdomen demonstrated 6 legs and 6 side arms were present, with one strut penetration anteriorly into the duodenum.Approximately after thirteen months, computed tomography scan showed, 6 legs and only 5 side arms were present, with the aforementioned duodenal strut no longer identified.The side arm most likely fractured into the duodenum and passed out through the digestive system sometime between that year.One year and five months later, computed tomography of the abdomen revealed several filter legs penetrated the inferior vena cava.Due to the risk of further penetration and possible filter fracture, the patient would like to remove the filter.Nine months later, the patient presented for filter removal, an access made via jugular vein, cavogram showed the filter apex against the right posterior lateral caval wall.One of the side arms was missed.All other structures were present.Multiple leg penetrations.Attempted to advance a snare around the filter apex but was unsuccessful as the hook was adherent to the posterior caval wall.Again, attempted to grab the filter hook with bronchial forceps, but was unsuccessful.A loop snare was performed using an omni select catheter and glide wire.Once the loop snare was around the apex of the filter, using mild tension on the filter, able to carefully dissect tissue away from the filter hook.Once this was accomplished, able to grasp the apex with the forceps, and advance the sheath over the filter, release the legs.Filter was removed and examined, demonstrated 6 intact legs and 5 intact arms.Fluoroscopic evaluation of the chest and abdomen did not demonstrate the fractured fragment.Gross description revealed, the specimen consists of 11 wires coiled together at one end ranging from 3.5 to 4.5 cm in length.Some minute soft tissue was present.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter limb detachment and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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.(expiry date: 07/2012) 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 through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis.At some time, post filter deployment, it was alleged that the filter difficult to remove, struts perforated, and detached.The device has been removed percutaneously.The patient reportedly diagnosed with pulmonary embolism post implant; 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 after being diagnosed with deep vein thrombosis.At some time, post filter deployment, it was alleged that the filter was difficult to remove, struts perforated, and detached.The device has been removed percutaneously after multiple attempts.The patient reportedly diagnosed with pulmonary embolism; 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 eleven months post filter deployment for a patient with right leg deep vein thrombosis and contraindications to anticoagulation, computed tomography of the abdomen and pelvis without contrast revealed several filter legs projected beyond the wall of the inferior vena cava with one leg abutted the duodenum and the other contacted the right lateral wall of the abdominal aorta.After three years and seven months, computed tomography of the abdomen demonstrated 6 legs and 6 side arms were present, with one strut penetration anteriorly into the duodenum.Approximately after thirteen months, computed tomography scan showed, 6 legs and only 5 side arms were present, with the aforementioned duodenal strut no longer identified.The side arm most likely fractured into the duodenum and passed out through the digestive system sometime between that year.One year and five months later, computed tomography of the abdomen revealed several filter legs penetrated the inferior vena cava.Due to the risk of further penetration and possible filter fracture, the patient would like to remove the filter.Nine months later, the patient presented for filter removal, an access made via jugular vein, cavogram showed the filter apex against the right posterior lateral caval wall.One of the side arms was missed.All other structures were present.Multiple leg penetrations.Attempted to advance a snare around the filter apex but was unsuccessful as the hook was adherent to the posterior caval wall.Again, attempted to grab the filter hook with bronchial forceps, but was unsuccessful.A loop snare was performed using an omni select catheter and glide wire.Once the loop snare was around the apex of the filter, using mild tension on the filter, able to carefully dissect tissue away from the filter hook.Once this was accomplished, able to grasp the apex with the forceps, and advance the sheath over the filter, release the legs.Filter was removed and examined, demonstrated 6 intact legs and 5 intact arms.Fluoroscopic evaluation of the chest and abdomen did not demonstrate the fractured fragment.Gross description revealed, the specimen consists of 11 wires coiled together at one end ranging from 3.5 to 4.5 cm in length.Some minute soft tissue was present.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc), filter limb detachment and retrieval difficulties.Additionally, it can be confirmed that the patient experienced pulmonary embolism 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: 07/2012).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 X FILTER SYSTEM - FEMORAL
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10586124
• MDR Text Key: 208518559
• Report Number: 2020394-2020-05814
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• PMA/PMN Number: K082305
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF400F
• Device Lot Number: GFTE3390
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: METOPROLOL, LISINOPRIL AND CLONIDINE; METOPROLOL, LISINOPRIL AND CLONIDINE; SYNTHROID, TOPROL, CLARITIN, DARVOCET; SYNTHROID, TOPROL, CLARITIN, DARVOCET; VALIUM, BENTYL, PREVACID, COUMADIN; VALIUM, BENTYL, PREVACID, COUMADIN; METOPROLOL, LISINOPRIL AND CLONIDINE; SYNTHROID, TOPROL, CLARITIN, DARVOCET; VALIUM, BENTYL, PREVACID, COUMADIN
• Patient Outcome(s): Life Threatening