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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Perforation of Vessels (2135); Blood Loss (2597)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
Exact implant date is unknown; therefore, implant date is estimated.
 
Event Description
It was reported that a perforation occurred.In (b)(6) 1988, patient was implanted with a greenfield vena cava filter (gvcf).Approximately, (b)(6) 2018, patient was admitted to the hospital for upper gastrointestinal bleed.An endoscopy was performed, which revealed a large kind of material could not be retrieved, which was cause of the bleeding, protruding into the duodenum and could not be removed endoscopically, and then the snare got stuck to this also.For that reason, the patient needed to have an exploratory laparotomy rather urgently.During this procedure to remove the foreign body, it was found that the hook of the gvcf had perforated through to the duodenum.On (b)(6) 2018 a computed tomography (ct) scan, noted a deformity involving the right lateral ivc filter with extension into the duodenum but no evidence of contrast extravasation.
 
Manufacturer Narrative
E: initial reporter updated.Exact implant date is unknown; therefore, implant date is estimated.
 
Event Description
It was reported that a perforation occurred.In (b)(6) 1988, patient was implanted with a greenfield vena cava filter (gvcf).Approximately, (b)(6) 2018, patient was admitted to the hospital for upper gastrointestinal bleed.An endoscopy was performed, which revealed a large kind of material could not be retrieved, which was cause of the bleeding, protruding into the duodenum and could not be removed endoscopically, and then the snare got stuck to this also.For that reason, the patient needed to have an exploratory laparotomy rather urgently.During this procedure to remove the foreign body, it was found that the hook of the gvcf had perforated through to the duodenum.On (b)(6) 2018 a computed tomography (ct) scan, noted a deformity involving the right lateral ivc filter with extension into the duodenum but no evidence of contrast extravasation.
 
Event Description
It was reported that a perforation occurred.In november 1988, patient was implanted with a greenfield vena cava filter (gvcf).Approximately, (b)(6) 2018, patient was admitted to the hospital for upper gastrointestinal bleed.An endoscopy was performed, which revealed a large kind of material could not be retrieved, which was cause of the bleeding, protruding into the duodenum and could not be removed endoscopically, and then the snare got stuck to this also.For that reason, the patient needed to have an exploratory laparotomy rather urgently.During this procedure to remove the foreign body, it was found that the hook of the gvcf had perforated through to the duodenum.On (b)(6) 2018 a computed tomography (ct) scan, noted a deformity involving the right lateral ivc filter with extension into the duodenum but no evidence of contrast extravasation.It was further reported that the patients date of birth was (b)(6) 1948.
 
Manufacturer Narrative
E: initial reporter updated.Exact implant date is unknown; therefore, implant date is estimated.
 
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Brand Name
GREENFIELD
Type of Device
FILTER, INTRAVASCULAR, CARDIOVASCULAR
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9088505
MDR Text Key159487324
Report Number2134265-2019-11132
Device Sequence Number1
Product Code DTK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup,Followup
Report Date 12/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/07/2020
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age69 YR
Patient Weight85
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