MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR INC. BARD DENALI IVC; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Device Problem Bent (1059)

Patient Problems Thrombus (2101); Malaise (2359)

Event Date 01/01/2013

Event Type  Injury  

Event Description

I am (b)(6) and i am (b)(6) ssa representative.(b)(6) disability case was denied in error on (b)(6) 2018 and he is suffering from severe medical complications as a result of the ivc filter, being bent while being inserted in his chest wall.This claimant is at risk of loosing his leg, as his mother lost her leg and (b)(6) is in need of medical attention and those shots in his stomach, and he is in need of the medication, warfarin, which he was prescribed.This case was expediated and not decided on social security law by whomever decided.(b)(6) is in need of his ivc filter removed asap, these blood clots are moving down; jeopardizing his leg to be amputated.All of his medical records were not used which gave a synopsis of being approved by ssa law.(b)(6) is severely ill, because this filter has not be retrieved as it should have been.(b)(6) is currently not on medication, nor is he under a doctor's care.All his medical reports point to being disabled.(b)(6) is homeless, a poor historian, and has no money for medicine, or a physician's care facility.

• Brand Name: BARD DENALI IVC
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR INC.
• MDR Report Key: 7344766
• MDR Text Key: 102766082
• Report Number: MW5075912
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2005
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention; Disability
• Patient Age: 39 YR
• Patient Weight: 82