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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR

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BOSTON SCIENTIFIC - MAPLE GROVE TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Model Number UNK141
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pulmonary Embolism (1498); Edema (1820); Pain (1994); Thrombosis (2100); Ulcer (2274)
Event Type  Injury  
Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation. A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted. If there is any further relevant information from that review, a supplemental medwatch will be filed. (b)(4).
 
Event Description
Same case as mdr id: 2134265-2016-11065. In (b)(6) 2003, two greenfield vena cava filters were implanted in the patient; one was placed infrarenally and one was place suprarenally. Since device implantation, the patient has experienced chronic blood clotting throughout his lower extremities, edema including his legs, limited mobility, significant venous stasis with ulcers in both of his legs, chronic pain syndrome and pulmonary embolism.
 
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Brand NameTITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC - MAPLE GROVE
one scimed place
maple grove MN 55311
Manufacturer Contact
sonali arangil
one scimed place
maple grove, MN 55311
7634941700
MDR Report Key6149469
MDR Text Key61589923
Report Number2134265-2016-11063
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K901659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Attorney
Type of Report Initial
Report Date 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
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

Patient Treatment Data
Date Received: 12/06/2016 Patient Sequence Number: 1
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