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	10	10
Appropriate Term/Code Not Available	2	2
Material Split, Cut or Torn	2	2
Patient Device Interaction Problem	1	1
Backflow	1	1
Gradient Increase	1	1
Material Puncture/Hole	1	1
Product Quality Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Stretched	1	1
Obstruction of Flow	1	1
Material Integrity Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	11	11
Stenosis	9	9
Unspecified Heart Problem	7	7
Endocarditis	6	6
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
Pseudoaneurysm	3	3
Fibrosis	3	3
Stroke/CVA	2	2
Pulmonary Dysfunction	1	1
Failure of Implant	1	1
Exsanguination	1	1
Inflammation	1	1
Abdominal Distention	1	1
Obstruction/Occlusion	1	1
Prolapse	1	1
Valvular Stenosis	1	1
Abscess	1	1
Calcium Deposits/Calcification	1	1
Ruptured Aneurysm	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1
Aortic Valve Insufficiency/ Regurgitation	1	1
Low Blood Pressure/ Hypotension	1	1
Fistula	1	1