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	10/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device was tilted and had perforated the mesentery.On (b)(6) 2003, the patient was implanted with a greenfield filter.The patient was the victim of a high speed collision which resulted in damage to the bilateral lower extremities.On (b)(6) 2019, the patient received an abdominal ct scan to evaluate inferior vena cava (ivc) filter placement.There was a mild tilt of the long axis of the filter with the cephalad apex abutting the anterior wall of the ivc.There was evidence of several perforated filter struts.There was filter strut perforation along the posterior left lateral aspect extending into the adjacent adipose tissue by approximately 3 mm, abutting the anterior longitudinal ligament.There was filter strut perforation along the anterior aspect of the ivc extending approximately 4 mm into the adjacent adipose tissue.There was filter strut perforation along the right lateral aspect of the ivc extending approximately 4 mm into the adjacent adipose tissue.Finally, there was filter strut perforation along the posterior aspect of the ivc extending approximately 5 mm into the adjacent adipose tissues abutting the anterior longitudinal ligament.No further patient complications were reported.

• Brand Name: GREENFIELD
• Common Device Name: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; model farm road; cork ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15299065
• Report Number: 2124215-2022-31533
• Device Sequence Number: 7167310
• 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: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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: 03/01/2006
• Device Model Number: 43175
• Device Catalogue Number: 43175
• Device Lot Number: 0005424545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2003
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR
• Patient Sex: Male