MAUDE Adverse Event Report: ADVANCED CRITICAL DEVICES, INC. FILTER ALN FEMORAL; ALN VENA CAVA FILTER

Model Number	FF.HOOK
Medical Device Problem Codes	Entrapment of Device (1212); Device Slipped (1584)
Health Effect - Clinical Codes	Exsanguination (1841); Hematoma (1884)
Date of Event	01/18/2019
Type of Reportable Event	Death
Event or Problem Description
A (b)(6) female with past medical history of recurrent deep vein thrombosis and pulmonary thromboemboli, hypertension, and copd presented on (b)(6) 2019 with complaint of right upper quadrant abdominal pain and was diagnosed with acute cholecystitis.She underwent laparoscopic cholecystectomy and placement of inferior vena cave filter.Pt was discharged on (b)(6) 2019.After discharge, pt was found deceased.Autopsy was requested by patient's family.Anatomic preliminary diagnosis found retroperitoneal hemorrhage (right retroperitoneal hematoma, six struts of an inferior vena cava filter perforating the wall of the inferior vena cava).The autopsy findings noted that the cholecystectomy surgical bed was free of undue hemorrhage or evidence of infection.The autopsy findings are preliminary.Histologic examination is pending.

• Brand Name: FILTER ALN FEMORAL
• Common Device Name: ALN VENA CAVA FILTER
• Manufacturer (Section D): ADVANCED CRITICAL DEVICES, INC.; cleveland OH
• MDR Report Key: 8358178
• Report Number: 8358178
• Device Sequence Number: 13931899
• Product Code: DTK
• UDI-Device Identifier: 03760017680042
• UDI-Public: 03760017680042
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2019
• Report Date (Section F): 02/07/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: FF.HOOK
• Device Catalogue Number: 23859 (VENDCAT : GTIN)
• Device Lot Number: 140416
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/25/2019
• Date Report to Manufacturer: 02/07/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/07/2019
• 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: Death
• Patient Age: 57 YR
• Patient Weight: 95
• Date Report Sent to FDA: 02/07/2019