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

Model Number 43335

Device Problem Positioning Problem (3009)

Patient Problem Perforation (2001)

Event Date 10/06/2020

Event Type  Injury  

Event Description

It was reported that the filter was tilted and had perforated the confines of the inferior vena cava (ivc) and into surrounding structures.On (b)(6) 2009, the patient was implanted with the greenfield filter.On (b)(6) 2020, the patient underwent an abdominal and pelvic ct scan.The filter was observed to be tilted, with the apex abutting the ivc wall.Multiple struts had perforated the ivc wall, with one strut perforating the small intestine.There were no further reported patient complications.

• Brand Name: GREENFIELD
• Type of Device: 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: 15718733
• MDR Text Key: 302918753
• Report Number: 2124215-2022-42926
• Device Sequence Number: 1
• Product Code: DTK
• UDI-Device Identifier: 08714729124993
• UDI-Public: 08714729124993
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K955396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2012
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0013022790
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other