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
Material Split, Cut or Torn	2	2
Device Operates Differently Than Expected	2	2
Fracture	2	2
Restricted Flow rate	2	2
Torn Material	2	2
Crack	2	2
Product Quality Problem	2	2
Material Puncture/Hole	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Stretched	1	1
Degraded	1	1
Occlusion Within Device	1	1
Backflow	1	1
Gradient Increase	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Endocarditis	10	10
No Code Available	9	9
Stenosis	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
Fibrosis	3	3
Pulmonary Valve Insufficiency/ Regurgitation	3	3
Unspecified Heart Problem	3	3
Pseudoaneurysm	3	3
Valvular Insufficiency/ Regurgitation	3	3
Hemorrhage/Bleeding	2	2
Calcium Deposits/Calcification	2	2
Pulmonary Insufficiency	2	2
Death	2	2
Palpitations	1	1
Hepatitis	1	1
Chest Pain	1	1
Post Operative Wound Infection	1	1
No Known Impact Or Consequence To Patient	1	1
Inflammation	1	1
HIV, Human Immunodeficiency Virus	1	1
Abdominal Distention	1	1
Abscess	1	1
Exsanguination	1	1
Failure of Implant	1	1
Sudden Cardiac Death	1	1
Insufficiency, Valvular	1	1
Seizures	1	1
Fungus	1	1
Ruptured Aneurysm	1	1
Stroke/CVA	1	1
No Consequences Or Impact To Patient	1	1
Herpes	1	1
Pulmonary Dysfunction	1	1
Syncope	1	1
Thrombus	1	1
Aortic Valve Stenosis	1	1
Low Blood Pressure/ Hypotension	1	1
Fistula	1	1