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

Model Number	43175
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2004 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed the filter migrated in the suprarenal part of inferior vena cava (ivc) in the intra-hepatic segment.
Additional Manufacturer Narrative
Field change: a1,a2, b7,.
Event or Problem Description
On (b)(6) 2004 the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019 a computed tomography (ct) scan of the abdomen revealed the filter migrated in the suprarenal part of inferior vena cava (ivc) in the intra-hepatic segment.

• 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: 9943543
• Report Number: 2134265-2020-04620
• Device Sequence Number: 18999282
• Product Code: DTK
• UDI-Device Identifier: 08714729114666
• UDI-Public: 08714729114666
• 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: 2004
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2007
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0006441138
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/31/2020
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 219