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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 Device Dislodged or Dislocated (2923)
Patient Problems Arrhythmia (1721); Dyspnea (1816); Nausea (1970); Pain (1994); Perforation (2001); Vomiting (2144); Dizziness (2194)
Event Type  Injury  
Manufacturer Narrative
If implanted, give date: (b)(6) 2002. (b)(4). 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
In (b)(6) 2002, a greenfield vena cava filter was implanted. For the past 5-6 years, the patient has experienced severe upper right quadrant pain, nausea/vomiting, irregular heartbeat, dizziness, chest pain, shortness of breath while walking and continued blood clots. Ct scans and other testing have revealed the greenfield filter has tilted and all 6 feet have perforated the vena cava; one foot is abutting against the abdominal aorta. The patient will undergo surgery to remove the filter and reconstruct the inferior vena cava.
 
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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 Key6136935
MDR Text Key61187177
Report Number2134265-2016-10884
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 Patient
Type of Report Initial
Report Date 11/08/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received11/08/2016
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: 11/30/2016 Patient Sequence Number: 1
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