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

Catalog Number RF048F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Extravasation (1842)

Event Date 08/10/2006

Event Type  Injury  

Manufacturer Narrative

The device history record review could not be performed as the lot number is unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately one year and six months post filter deployment, computed tomography (ct) abdomen and pelvis with and without contrast was performed revealed the filter was in place with the inferior vena cava filter prongs perforating through the inferior vena cava wall, with two of the lateral prongs lying adjacent to the aortic wall.Approximately one month later, patient presented with abdominal pain.Subsequent, computed tomography revealed the filter prongs pierce the inferior vena cava wall and extend into the retroperitoneum.Approximately one year later, computed tomography revealed the position of the filter was asymmetric and tilted approximately 20-degrees toward the right side.The legs of the filter have perforated through the wall of the inferior vena cava.Approximately ten years later, computed tomography revealed the filter was tilted posteriorly with the filter cone lying adjacent to the posterior wall of the vena cava.All the filter legs penetrate the inferior vena cava.One leg was seen penetrating the right lateral wall of the abdominal aorta.Another was in contact with the posterior wall of the abdominal aorta.Another leg penetrates the posterior wall of the duodenum and two legs penetrate into the pericaval fat.Therefore, the investigation is confirmed for perforation of the inferior vena cava (ivc) and filter tilt.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 after being diagnosed with deep vein thrombosis/pulmonary embolism, in conjunction with trauma situation/motor vehicle accident and contraindication to anticoagulation.At some time post filter deployment, it was alleged that the filter tilted and struts perforated into the abdominal aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.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 five months later post filter deployment, an x-ray of kidney, ureter and bladder was performed for inferior vena cava filter evaluation.The study showed that an inferior vena cava filter projected to the right side of the spine at the level of l2.After six months, an x-ray of kidney, ureter and bladder was performed for epigastric pain and the study showed stable positioning of the inferior vena cava filter.After seven months, a computed tomography of abdomen and pelvis was performed for hematuria.The study showed that an infra renal inferior vena cava filter was in place with the inferior vena filter prongs perforated through the inferior vena cava wall, with two of the lateral prongs laid adjacent to the aortic wall.After one month, a computed tomography of abdomen and pelvis was performed for abdominal pain in comparison with a previous computed tomography study from an outside facility which showed the inferior vena cava filter prongs pierced the inferior vena cava wall and extended into the retroperitoneum.The present study showed that there was an infra renal inferior vena cava filter, and the filter was located asymmetrically within the inferior vena cava.Also, several prongs pierced and extended through the inferior vena caval wall into the retroperitoneum, without evidence of associated fat stranding or active contrast extravasation.Also, several of these prongs touched the aortic wall and laid against the aorta.The inferior vena cava filter measured 1.9 x 1.3 cm.After two months, an x-ray of lumbar spine was performed for lumbar pain.The study showed that an inferior vena cava filter was in place at the l2-l3 level.After ten days, a computed tomography of abdomen and pelvis was performed for hernia.The study showed that an infra renal inferior vena cava filter was noted, and the inferior vena cava filter prong extended outside of the inferior vena cava lumen though active extravasation was noted.A computed tomography of lumbar spine was performed on the same day for lower back pain and the study showed that an inferior vena cava filter has been placed with distal prongs outside of the inferior vena cava lumen.After nine months, a computed tomography of abdomen and pelvis was performed for malpositioning of the inferior vena cava filter.The study showed that a greenfield type of inferior vena cava filter was demonstrated, and the inferior vena cava was in an infra renal position with the tip below the right renal artery, also, the position of the filter was asymmetric and tilted approximately 20 degrees towards the right side.The study also showed that the legs of the filter have perforated through the wall of the inferior vena cava.After two years and one month, a computed tomography of abdomen and pelvis was performed for abdominal pain.The study showed that there was redemonstration of an infra renal inferior vena cava filter which was stable in appearance and located asymmetrically within the inferior vena cava with several prongs extended through the caval wall into the retroperitoneum and several touched the aortic wall.After four months and five months, an x-ray of lumbar spine was performed for pain and the study showed there was an inferior vena cava filter in place.After one month, it was mentioned in the patient¿s past medical history that the patient had an inferior vena cava filter and the inferior vena cava filter pressed against high pressure and was told that it cannot be removed.After three years, an x-ray of abdomen was performed for abdominal pain.The study showed that there was redemonstration of an inferior vena cava filter, the proximal portion of which was superimposed on the mid body of l2, unchanged.Also, one of the prongs was deviated cephalad, as before.No gross change in the configuration or location of the inferior vena cava filter.After on month, a computed tomography of abdomen and pelvis was performed for acute embolism and thrombosis of veins of lower extremity.The study showed that there was an inferior vena cava filter in place.Therefore, the investigation is confirmed for perforation of the inferior vena cava, filter tilt and material deformation.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.H10: b2,b6,b7,d10,g3, h6(patient, device).H11: d4(corporate lot no).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 through the litigation process that a vena cava filter was placed in a patient after being diagnosed with deep vein thrombosis/pulmonary embolism, in conjunction with trauma situation/motor vehicle accident and contraindication to anticoagulation.At some time post filter deployment, it was alleged that the filter tilted and struts perforated into the abdominal aorta.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: RECOVERY FILTER SYSTEM
• 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: 11574387
• MDR Text Key: 243122227
• Report Number: 2020394-2021-80253
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031328
• 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: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF048F
• Device Lot Number: GFOK0342
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/01/2022
• 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
• Treatment: HYDROCHLOROTHIAZIDE, PAXIL, TRAZODONE; HYDROCHLOROTHIAZIDE, PAXIL, TRAZODONE; VICODIN AND ATIVAN; VICODIN, LORTAB, LOVENOX, AND ATIVAN
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Race: White