TPLC - Total Product Life Cycle

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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	34	34
Insufficient Information	11	11
Appropriate Term/Code Not Available	3	3
Material Split, Cut or Torn	2	2
Restricted Flow rate	2	2
Material Puncture/Hole	1	1
Stretched	1	1
Backflow	1	1
Obstruction of Flow	1	1
Product Quality Problem	1	1
Gradient Increase	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	9	9
Stenosis	9	9
Endocarditis	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Valvular Insufficiency/ Regurgitation	4	4
Pulmonary Valve Insufficiency/ Regurgitation	4	4
Valvular Stenosis	3	3
Congenital Defect/Deformity	3	3
Unspecified Heart Problem	3	3
Bacterial Infection	3	3
Fibrosis	3	3
Stroke/CVA	2	2
No Information	2	2
Pulmonary Valve Stenosis	2	2
Pseudoaneurysm	2	2
Death	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
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