MAUDE Adverse Event Report: WILLIAM COOK EUROPE COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER; DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number	G48378
Medical Device Problem Codes	Malposition of Device (2616); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Pain (1994); Perforation of Vessels (2135)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
'it is alleged that "[pt] received a cook celect filter on (b)(6) 2013".It is also alleged "tilt", "vena cava perforation" & "organ perforation".[pt] alleges "i have shortness of breath and i am unable to walk long distances due to my legs swelling.My right thigh is swollen and the vein is infected where the ivc filter was implanted.Regular exercise is strenuous to me now.Lots of pain in my left thigh".[pt] alleges: "perforation: the filter is tilted anteriorly and medially and the hook does not contact the ivc wall.All the struts of the ivc filter perforate the ivc up to 12mm.One anterior strut perforates the ivc wall 12mm and contacts the bowel.One medial strut perforates the ivc wall 5mm and contacts the aorta.One medial strut perforates the ivc wall 5mm and resides within the soft tissues.One posterior strut perforates 8mm and resides within the soft tissues.One lateral strut perforates the ivc wall 7mm and resides within the soft tissues.Two lateral struts perforate the ivc wall 5mm and 10mm and contact the bowel".

• Brand Name: COOK CELECT FEMORAL AND JUGULAR VENA CAVA FILTER
• Common Device Name: DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 9402295
• Report Number: 3005580113-2019-00846
• Device Sequence Number: 19552536
• Product Code: DTK
• UDI-Device Identifier: 00827002483781
• UDI-Public: (01)00827002483781(17)141219(10)E3025505
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/03/2019
• Report Date (Section F): 12/03/2019

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: 12/19/2014
• Device Model Number: G48378
• Device Catalogue Number: IGTCFS-65-UNI-CELECT-PERM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/29/2019
• Event Location: Other
• Date Report to Manufacturer: 11/27/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Weight: 78
• Date Report Sent to FDA: 12/03/2019