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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Perforation (2001)

Event Date 04/05/2017

Event Type  Injury  

Event Description

It was reported that the greenfield filter caused a grade 3 perforation.On or about (b)(6) 2003, patient was implanted with two greenfield filters.On or about (b)(6) 2017, patient underwent a computerized tomography (ct) scan of the abdomen and pelvis.The first greenfield filter caused grade 3 perforation with the superior aspect abutting the appendix.Additionally, the ventral strut perforated beyond the vena cava wall and abutted the right common iliac artery, and the right lateral strut had entered the right psoas muscle.The second greenfield filter also caused grade 3 perforation with the posterior struts abutting the left common iliac artery and the superior sacrum.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14207957
• MDR Text Key: 290070672
• Report Number: 2134265-2022-04652
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K901659
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male