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

Model Number	43175
Medical Device Problem Codes	Positioning Problem (3009); Migration (4003)
Health Effect - Clinical Codes	Perforation (2001); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)
Date of Event	12/22/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2003, the patient was surgically implanted with a greenfield titanium vena cava filter.On (b)(6) 2019, the patient received a computerized tomography (ct) scan, which revealed the following: the struts from the implanted filter had perforated the inferior vena cava (ivc) wall, one strut had perforated the small bowel, and there was a small bowel obstruction possibly caused by the migration of the ivc filter into the small bowel.On (b)(6) 2019, the patient had a open laparotomy surgery to remove an ivc filter strut and repair enterotomy.The strut had substantially migrated to the ivc wall, the filter was tilted, and another strut perforated the ivc wall.The strut was found encapsulated within the small bowel causing the obstruction.Heavy scissors were used to divide the strut and free the bowel.The remainder of the filter remains in an unsafe location that could require further surgery.

• 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: 11901355
• Report Number: 2134265-2021-06961
• Device Sequence Number: 17065828
• 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: 2003
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/28/2021

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: 05/01/2006
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0005586625
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 05/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention