TPLC - Total Product Life Cycle

show TPLC since

Device	heart valve, more than minimally manipulated allograft
Definition	For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.
Product Code	OHA
Device Class	Unclassified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	40	40
Insufficient Information	12	12
Appropriate Term/Code Not Available	3	3
Material Split, Cut or Torn	2	2
Restricted Flow rate	2	2
Material Puncture/Hole	1	1
Material Integrity Problem	1	1
Patient Device Interaction Problem	1	1
Stretched	1	1
Backflow	1	1
Obstruction of Flow	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Gradient Increase	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	11	11
Stenosis	9	9
Endocarditis	9	9
Unspecified Heart Problem	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Valvular Insufficiency/ Regurgitation	4	4
Pulmonary Valve Insufficiency/ Regurgitation	4	4
Pulmonary Valve Stenosis	3	3
Valvular Stenosis	3	3
Congenital Defect/Deformity	3	3
Pseudoaneurysm	3	3
Bacterial Infection	3	3
Fibrosis	3	3
Stroke/CVA	2	2
No Information	2	2
Death	1	1
Pulmonary Dysfunction	1	1
Failure of Implant	1	1
Insufficiency, Valvular	1	1
Exsanguination	1	1
Inflammation	1	1
Abdominal Distention	1	1
Obstruction/Occlusion	1	1
Pulmonary Insufficiency	1	1
Prolapse	1	1
Abscess	1	1
Calcium Deposits/Calcification	1	1
Ruptured Aneurysm	1	1
Hemorrhage/Bleeding	1	1
Aortic Valve Insufficiency/ Regurgitation	1	1
Low Blood Pressure/ Hypotension	1	1
Fistula	1	1