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	31	31
Insufficient Information	12	12
Appropriate Term/Code Not Available	4	4
Obstruction of Flow	4	4
Restricted Flow rate	2	2
Material Split, Cut or Torn	2	2
Gradient Increase	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Stretched	1	1
Material Integrity Problem	1	1
Backflow	1	1
Degraded	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	9	9
Endocarditis	8	8
Pulmonary Valve Stenosis	6	6
Stenosis	5	5
Congenital Defect/Deformity	5	5
Bacterial Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
No Information	4	4
Valvular Insufficiency/ Regurgitation	3	3
Valvular Stenosis	3	3
Fibrosis	3	3
Unspecified Heart Problem	3	3
Pseudoaneurysm	2	2
Death	2	2
Calcium Deposits/Calcification	1	1
Stroke/CVA	1	1
Sudden Cardiac Death	1	1
Abdominal Distention	1	1
Exsanguination	1	1
Fistula	1	1
Hemorrhage/Bleeding	1	1
Low Blood Pressure/ Hypotension	1	1
Failure of Implant	1	1
Insufficiency, Valvular	1	1
Inflammation	1	1
Pulmonary Dysfunction	1	1
Pulmonary Insufficiency	1	1
Abscess	1	1
Pulmonary Valve Insufficiency/ Regurgitation	1	1
No Code Available	1	1
Ruptured Aneurysm	1	1