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); Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994); Blood Loss (2597)

Event Date 10/21/2015

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 (dhr) review is not required.Investigation summary: the device was not returned for evaluation.Images were not provided.Medical records were provided and reviewed.There was no device deficiencies were identified within the medical records.Therefore, the investigation is inconclusive for perforation of the ivc and retrieval difficulties as no objective evidence has been provided to confirm any alleged deficiency with the filter.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.(expiry date: 01/2013).

Event Description

It was reported through the litigation process that a vena cava filter was placed in the patient in conjunction with a trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated.It was further reported that the filter punctured the aorta, causing an aortocaval (av) fistula between the ivc and aorta and caused lungs filling up with blood.The patient underwent stenting to seal the aortocaval fistula, and the device was removed percutaneously through a difficult, complex ivc filter retrieval surgery.The patient had difficulty in breathing and experienced pain; 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 the patient in conjunction with a trauma situation/motor vehicle accident.At some time post filter deployment, it was alleged that the filter perforated.It was further reported that the filter punctured the aorta, causing an aortocaval fistula between the inferior vena cava and aorta and caused lungs filling up with blood.The patient underwent stenting to seal the aortocaval fistula, and the device was removed percutaneously through a difficult, complex inferior vena cava filter retrieval surgery.The patient had difficulty in breathing and experienced pain; however, 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, six years of post-deployment, the patient desired to have her filter removed, but was told that it would entail an open surgery; however, the patient preferred to pursue less invasive options.On the same day, computed tomography report taken five months before from an outlying facility was reviewed.The images showed an infra-renal bard g2x inferior vena cava filter was complicated by multifocal penetration into the adjacent small bowel, vertebral body, and adjacent aortic wall.On the next day, a complex filter retrieval with one-hour additional procedure time was performed.Through the right internal jugular vein access, over an amplatz wire, a 14 french cook sheath was placed in the inferior vena cava at the level of the filter apex.An inferior vena cavo gram was performed.Rigid forceps were advanced and used to dissect free the embedded filter apex.The retrieval hook was engaged with the rigid forceps and the 14 french sheath was advanced to collapse and capture of the filter, which was then removed and examined.Therefore, the investigation is confirmed for the perforation of the inferior vena cava (ivc) and retrieval difficulties.Per medical records, complex filter retrieval with one-hour additional procedure time was performed to engage the apex of the filter using forceps but were unsuccessful due to filter embedment.This could have contributed to the retrieval difficulties.However, 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: b7, d4(expiry date: 01/2013), g3, h6 (method, conclusion).H11: g1, h6 (result).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
• 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: 8704481
• MDR Text Key: 148193170
• Report Number: 2020394-2019-01036
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082305
• 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: 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• 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: GFTL2127
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2010
• 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
• Treatment: ALUM/MAGNESIUM HYDROXIDE/SIMETHICONE; ALUM/MAGNESIUM HYDROXIDE/SIMETHICONE; ASPIRIN, CLOBETASOL, KETOCONAZOLE, MINOCYCLINE; ASPIRIN, CLOBETASOL, KETOCONAZOLE, MINOCYCLINE; COUMADIN, HYDROCHLOROTHIAZIDE, ALPRAZOLAM; COUMADIN, HYDROCHLOROTHIAZIDE, ALPRAZOLAM; FENTANYL PATCH, TRAMADOL, RANEXA; FENTANYL PATCH, TRAMADOL, RANEXA; MILK OF MAGNESIA, TEMAZEPAM, VISTARIL; MILK OF MAGNESIA, TEMAZEPAM, VISTARIL; SIMVASTATIN, TYLENOL, DOCUSATE; SIMVASTATIN, TYLENOL, DOCUSATE; ALUM/MAGNESIUM HYDROXIDE/SIMETHICONE; ASPIRIN, CLOBETASOL, KETOCONAZOLE, MINOCYCLINE; COUMADIN, HYDROCHLOROTHIAZIDE, ALPRAZOLAM; FENTANYL PATCH, TRAMADOL, RANEXA; MILK OF MAGNESIA, TEMAZEPAM, VISTARIL; SIMVASTATIN, TYLENOL, DOCUSATE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 99 KG