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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); Obstruction of Flow (2423); Malposition of Device (2616)
Patient Problem Abdominal Pain (1685)
Event Date 01/07/2019
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: the device history record (dhr) could not be performed as the lot number is unknown. Investigation summary: the device was not returned for evaluation. Medical records were not provided. Therefore, the investigation is inconclusive for filter migration, filter tilt, occlusion of the ivc filter, filter detachment, and perforation of inferior vena cava (ivc), 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. (device: 2907, 4001).

 
Event Description

It was reported through the litigation process that the filter migrated, tilted, occluded, detached and perforated. Approximately fourteen years and five months post filter deployment, a computed tomography revealed that the filter perforated at l2-l3 to mid-l4 interspace with a grade 3. The filter strut extended 5mm outside the cava wall abutting the aorta, 14 mm outside the cava wall and mended into the right anterosuperior l4 vertebra and 11 mm outside the cava wall abutting the right common iliac artery. A right posterior strut extended 6 mm outside the cava wall abutting the right psoas muscle. The filter was removed successfully. It was further reported that the patient experienced abdominal pain; however, 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 Key10243825
MDR Text Key197919316
Report Number2020394-2020-04355
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
Reporter Occupation
Type of Report Initial
Report Date 07/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/08/2020
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 Received06/19/2020
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: 07/08/2020 Patient Sequence Number: 1
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