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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER SYSTEM VENA CAVA FILTER Back to Search Results
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.

 
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Brand NameRECOVERY FILTER SYSTEM
Type of DeviceVENA 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 Key12391367
MDR Text Key268906572
Report Number2020394-2021-80710
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK031328
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 08/31/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberRF048F
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2021
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 TREATMENT DATA
Date Received: 08/31/2021 Patient Sequence Number: 1
Treatment
KLONOPIN, EFFEXOR, LIPITOR, AND SYNTHROID
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