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	Perforation (2001)
Date of Event	08/28/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2006.On (b)(6) 2017, it was noted there was a perforation.The filter was noted to be tilted.No further patient complications were reported.
Event or Problem Description
A greenfield filter was implanted on (b)(6) 2006.On(b)(6) 2017, it was noted there was a perforation.The filter was noted to be tilted.No further patient complications were reported.It was further reported that the patient present with a pulmonary embolism, inability to anticoagulated.Vascular access was obtained via the right internal jugular vein, where a guidewire was also passed.A 10fr sheath was placed over the wire and the wire was removed and exchanged for a 0.035 guidewire.The greenfield filter was advanced through the dilator and through the right atrium into the ivc infrarenal position.A 12.5 fr dilator wire was placed over the wire, followed by the dilator and sheath from the delivery system.The sheath was placed at the l1 vertebral body, the dilator was removed.The ivc was measured at 15mm in diameter.At this point the dilator and wire was placed through the sheath, the sheath was then advanced, and the dilator was removed over the wire.The greenfield filter and its delivery system were then placed and positioned over the l2-3 vertebral bodies.The sheath was then pulled back and the filter was deployed without difficulty.There was minimal tilt over the wire.The wire was then pulled back and the delivery system was then extracted with the wire in place.A triple lumen central line was then placed over the wire and was sutured in place.Sterile dressing was then applied.The patient tolerated the procedure well.

• 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: 9834549
• Report Number: 2134265-2020-03210
• Device Sequence Number: 1212840
• 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: 2006
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2020

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: 06/20/2008
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0007798116
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/18/2020
• Supplement Date Received by Manufacturer: 04/02/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 04/22/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 53 YR