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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GREENFIELD FILTER, INTRAVASCULAR, CARDIOVASCULAR

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BOSTON SCIENTIFIC CORPORATION GREENFIELD FILTER, INTRAVASCULAR, CARDIOVASCULAR Back to Search Results
Device Problems Break (1069); Migration (4003)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/08/2020
Event Type  Malfunction  
Event Description

It was reported that the filter was fractured and embolized. A greenfield filter was implanted in 2005. On an unknown date 15 years later the patient presented to the hospital with 1 week of hemoptysis and had a ct-angiogram of their chest performed. The imaging showed that there were multiple fragments of the fractured filter. Had occurred. Fragmented struts were identified in the infrarenal ivc and one strut was identified extravascular in the left-lower-lobe. The patient underwent a bronchoscopy and found minimal blood in the medial segment of left-lower-lobe where the extravascular ivc filter fragment was embolized which was thought to be the likely source of hemoptysis. All the intravascular fragmented struts and the ivc filter were retrieved endovascularly. After multidisciplinary assessment, the decision was made to leave the extravascular embolized strut in-situ since there were no further episodes of hemoptysis. One-week later, the patient was readmitted with massive hemoptysis and hemodynamic instability. Endovascular snare was attempted but was unsuccessful in retrieving the left-lower-lobe embolized strut, hence decision was made to proceed with left-lower-lobe wedge resection. Post-operative course was uneventful, with no further episodes of hemoptysis and the patient was discharged home in a stable condition.

 
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Brand NameGREENFIELD
Type of DeviceFILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10359424
MDR Text Key201875942
Report Number2134265-2020-09856
Device Sequence Number1
Product Code DTK
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 08/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/03/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2020
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/03/2020 Patient Sequence Number: 1
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