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

Catalog Number RF048F

Device Problems Migration or Expulsion of Device (1395); Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/14/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturing review: a 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 fourteen years and nine months later, a computed tomography of the lumbar spine was conducted.All tines of the filter had perforated through the wall of the inferior vena cava.There is an inferior vena cava filter with its proximal end terminating at the mid l2 level.The inferior limbs of the filter extended beyond/external to the inferior vena cava.Two of the anterior limbs extended into or adjacent to distal stomach/proximal duodenum.Right lateral limb abutted the medial aspect of right hepatic lobe.A left posterior lateral limb protruded into and caused chronic bony remodeling of the anterior inferior aspect of l3 vertebra.A lucent bony tract lined, and rim of sclerosis surrounded the filter limb.After two weeks, the patient underwent surgery to retrieve the inferior vena cava filter.An open surgery was conducted, entering directly to the abdomen with an incision.The vena cava was dissected out at the level of where the filter was circumferentially exposed.The right renal vein was significantly higher than the left, and distal control was achieved of the vena cava by exposing the vena cava above the left, but below the right renal vein.Many lumbar veins were encountered, and these were ligated and divided.Hooks were cut off the ends of all the filter¿s feet and then the patient was heparinized.The vena cava was occluded, a suture towards the top of the filter was made, and with a small incision the tip of the filter was grasped and removed from within the vena cava.The duodenum was repaired, and the abdomen was closed.Excellent homeostasis was achieved.Therefore, the investigation is confirmed for the alleged filter limb detachment and perforation of the inferior vena cava.However, the investigation is inconclusive for the alleged filter tilt and filter migration.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.

Event Description

It was reported through the litigation process that the filter tilted and migrated to l1-l2 disc space and struts perforated the ivc wall.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: 12391367
• MDR Text Key: 268906572
• Report Number: 2020394-2021-80710
• 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
• Report Date: 08/31/2021

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: RF048F
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/31/2021
• 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: KLONOPIN, EFFEXOR, LIPITOR, AND SYNTHROID
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 54