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	42	42
Insufficient Information	13	13
Obstruction of Flow	5	5
Appropriate Term/Code Not Available	5	5
Product Quality Problem	2	2
Device Operates Differently Than Expected	2	2
Fracture	2	2
Material Split, Cut or Torn	2	2
Torn Material	2	2
Restricted Flow rate	2	2
Crack	2	2
Occlusion Within Device	1	1
Backflow	1	1
Device Contamination with Chemical or Other Material	1	1
Gradient Increase	1	1
Material Puncture/Hole	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Degraded	1	1
Stretched	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Endocarditis	10	10
Stenosis	9	9
No Code Available	9	9
Insufficient Information	9	9
No Information	7	7
Pulmonary Valve Stenosis	6	6
Congenital Defect/Deformity	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Bacterial Infection	4	4
Valvular Stenosis	4	4
Pulmonary Valve Insufficiency/ Regurgitation	3	3
Fibrosis	3	3
Unspecified Heart Problem	3	3
Pseudoaneurysm	3	3
Valvular Insufficiency/ Regurgitation	3	3
Pulmonary Insufficiency	2	2
Calcium Deposits/Calcification	2	2
Death	2	2
Hemorrhage/Bleeding	2	2
Post Operative Wound Infection	1	1
Palpitations	1	1
No Known Impact Or Consequence To Patient	1	1
Hepatitis	1	1
Chest Pain	1	1
Abdominal Distention	1	1
Inflammation	1	1
HIV, Human Immunodeficiency Virus	1	1
Exsanguination	1	1
Abscess	1	1
Seizures	1	1
Insufficiency, Valvular	1	1
Sudden Cardiac Death	1	1
Failure of Implant	1	1
Fungus	1	1
Ruptured Aneurysm	1	1
Pulmonary Dysfunction	1	1
Herpes	1	1
No Consequences Or Impact To Patient	1	1
Stroke/CVA	1	1
Syncope	1	1
Aortic Valve Stenosis	1	1
Low Blood Pressure/ Hypotension	1	1
Thrombus	1	1
Fistula	1	1