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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. SIMON NITINOL FILTER SYSTEM VENA CAVA FILTER Back to Search Results
Model Number 2120F
Device Problems Migration or Expulsion of Device (1395); Difficult to Remove (1528); Malposition of Device (2616)
Patient Problems Abdominal Pain (1685); Hematoma (1884)
Event Date 08/02/2017
Event Type  Injury  
Manufacturer Narrative

Manufacturing review: 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 three days post filter deployment, computed tomography (ct) showed that an infra renal inferior vena cava filter was present and the patient was diagnosed with acute abdominal pain due to left psoas hematoma. Approximately nine years later, computed tomography revealed that the filter was tilted approximately 32 degrees. Also, it was observed that the ivc filter struts were projecting outside the lumen of the ivc wall. Approximately one year later, computed tomography revealed right retroperitoneal hematoma measured approximately 11 x 5 x 20 cm. An attempt was made to retrieve the filter. Through the right internal jugular vein access, real-time sonography was used to advance a 20-gauge needle into the internal jugular vein, a guide wire was passed, dilations were performed and a 16-french long sheath was placed in the inferior vena cava. This was followed by grasping of fibrous tissue and the filter with retrieval forceps. Numerous maneuvers were done with primary purpose to remove the embedded device off from the surrounding fibrous tissue, to turn the device to release from the surrounding fibrosis and advancement of sheath to dissect off the filter from the inferior vena cava wall. The filter tip could finally be grasped and the entire device was collapsed into the access sheath and removed. Eventually, next day the patient suffered complication. The patient had a tear on his inferior vena cava due to inferior vena cava filter strut perforation. Approximately four days later, computed tomography revealed evidence for extensive surrounding hematoma at the site of procedure and extensive hematoma in the retro peritoneum and mesentery extended into the pelvis. Therefore, the investigation is confirmed for perforation of the ivc, filter tilt and retrieval difficulties. However, the investigation is inconclusive for 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. (b)(4).

 
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. At some time post filter deployment, it was alleged that the filter tilted, migrated and struts perforated to the vena cava wall and mesentery. The device has been successfully removed after an attempted but unsuccessful percutaneous removal procedure. The patient reportedly experienced abdominal pain and was diagnosed with hematoma; however, the current status of the patient is unknown.

 
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Brand NameSIMON NITINOL 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 Key10282333
MDR Text Key199053812
Report Number2020394-2020-04481
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK970099
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 07/16/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2120F
Device Catalogue Number2120F
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 Received07/13/2020
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: 07/16/2020 Patient Sequence Number: 1
Treatment
ATENOLOL, ASPIRIN AND PLAVIX; CITALOPRAM HYDROBROMIDE AND FISH OIL ORAL CAPSULE; CLOPIDOGREL; COUMADIN, INVANZ, ATIVAN, LIPITOR AND AVODART; LOPRESSOR, ZOCOR, ERTAPENEM AND OMEPRAZOLE; LUPRON, METOPROLOL SUCCINATE AND ATORVASTATIN; SIMVASTATIN, CELEXA, ATENOLOL AND IMDUR; SUBLINGUAL NITROGLYCERIN, AVODART AND LOVENOX
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