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

Model Number	43335
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date is unknown therefore, best approximation date has been used.
Event or Problem Description
On (b)(6) 2014 the patient underwent placement of a greenfield vena cava filter.On a unknown date, a computed tomography (ct) scan revealed a positive tilt.The filter was posteriorly tilted and the apex abutted the posterior wall of the inferior vena cava.
Event or Problem Description
On (b)(6) 2014 the patient underwent placement of a greenfield vena cava filter.On a unknown date, a computed tomography (ct) scan revealed a positive tilt.The filter was posteriorly tilted and the apex abutted the posterior wall of the inferior vena cava.It was further reported that the patient had a ct of their abdomen on (b)(6) 2018.

• 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: 9949162
• Report Number: 2134265-2020-04734
• Device Sequence Number: 3271664
• Product Code: DTK
• UDI-Device Identifier: 08714729070276
• UDI-Public: 08714729070276
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K964284
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2020

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: 05/31/2017
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0017075414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/28/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 08/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 74 YR