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

Model Number	43175
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/14/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 1996 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed 3 of the 6 legs of the filter extended beyond the wall by 2mm.No adjacent organs were involved.The tip of the filter touched the posterior wall of the cava and the tip is at the level of the right renal vein and 2cm below left renal vein.Inferior portion of filter is 6.4cm above the iliac veins.
Event or Problem Description
On (b)(6) 1996 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed 3 of the 6 legs of the filter extended beyond the wall by 2mm.No adjacent organs were involved.The tip of the filter touched the posterior wall of the cava and the tip is at the level of the right renal vein and 2cm below left renal vein.Inferior portion of filter is 6.4cm above the iliac veins.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9943532
• Report Number: 2134265-2020-04627
• Device Sequence Number: 665465
• Product Code: DTK
• UDI-Device Identifier: 08714729114659
• UDI-Public: 08714729114659
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K901659
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 1996
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/1998
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0000244725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/20/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR