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

Model Number	43335
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	02/08/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a perforation occurred.On (b)(6) 2004, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan of the abdomen with contrast was performed and revealed the inferior vena cava (ivc) filter with tines minimally extending outside ivc.No surrounding stranding was noticed.There was a positive mesenteric perforation.Retro-aortic left renal vein noted with one of the tines slightly extending into the left vein.
Event or Problem Description
It was reported a perforation occurred.On (b)(6) 2004, the patient underwent placement of a greenfield vena cava filter.On (b)(6) 2019, a computed tomography (ct) scan of the abdomen with contrast was performed and revealed the inferior vena cava (ivc) filter with tines minimally extending outside ivc.No surrounding stranding was noticed.There was a positive mesenteric perforation.Retro-aortic left renal vein noted with one of the tines slightly extending into the left vein.

• 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: 9943787
• Report Number: 2134265-2020-04836
• Device Sequence Number: 10929178
• Product Code: DTK
• UDI-Device Identifier: 08714729124993
• UDI-Public: 08714729124993
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K955396
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/10/2007
• Device Model Number: 43335
• Device Catalogue Number: 43335
• Device Lot Number: 0006572446
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/24/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR