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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device mesh, surgical, synthetic, urogynecologic, for stress urinary incontinence, female, mini-sling
Definition Transvaginal surgical repair of female stress urinary incontinence (SUI) due to intrinsic sphincter deficiency (ISD) and/or urethral hypermobility.
Product CodePAH
Regulation Number 878.3300
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CALDERA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
COLOPLAST A/S
  SUBSTANTIALLY EQUIVALENT 2
MPATHY MEDICAL DEVICES, LTD.
  SUBSTANTIALLY EQUIVALENT 1
PROMEDON S.A.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 334 334
2015 274 274
2016 697 697
2017 127 127
2018 173 173
2019 297 297
2020 171 171
2021 318 318
2022 159 159
2023 154 154
2024 75 75

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1047 1047
Insufficient Information 623 623
Material Erosion 182 182
Migration 159 159
Break 147 147
Appropriate Term/Code Not Available 130 130
Migration or Expulsion of Device 88 88
Extrusion 68 68
Material Protrusion/Extrusion 52 52
Device Operates Differently Than Expected 48 48
Detachment of Device or Device Component 45 45
Positioning Failure 40 40
Patient-Device Incompatibility 38 38
Positioning Problem 28 28
Material Twisted/Bent 28 28
Device Appears to Trigger Rejection 25 25
Other (for use when an appropriate device code cannot be identified) 24 24
No Apparent Adverse Event 19 19
Detachment Of Device Component 18 18
Material Deformation 17 17
Device Dislodged or Dislocated 14 14
Malposition of Device 14 14
Bent 13 13
Defective Device 12 12
Difficult to Advance 11 11
Premature Activation 10 10
Fracture 9 9
Material Split, Cut or Torn 9 9
Patient Device Interaction Problem 7 7
Loose or Intermittent Connection 7 7
Therapeutic or Diagnostic Output Failure 6 6
Torn Material 6 6
Missing Information 6 6
Improper or Incorrect Procedure or Method 5 5
Material Fragmentation 5 5
Material Separation 5 5
Unexpected Therapeutic Results 5 5
Difficult To Position 4 4
Unintended Movement 4 4
Device Or Device Fragments Location Unknown 3 3
Deformation Due to Compressive Stress 3 3
Leak/Splash 3 3
Difficult or Delayed Separation 3 3
Separation Problem 2 2
Component Falling 2 2
Disconnection 2 2
Entrapment of Device 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Slipped 2 2
Stretched 2 2
Device Inoperable 2 2
Defective Component 2 2
Activation, Positioning or Separation Problem 2 2
Device-Device Incompatibility 2 2
Difficult to Remove 2 2
Material Too Rigid or Stiff 2 2
Obstruction of Flow 2 2
Split 2 2
Device Packaging Compromised 1 1
Contamination of Device Ingredient or Reagent 1 1
Missing Value Reason 1 1
Activation Failure 1 1
Expulsion 1 1
Material Integrity Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Human-Device Interface Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Incomplete or Missing Packaging 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unstable 1 1
Use of Device Problem 1 1
Device Emits Odor 1 1
Unsealed Device Packaging 1 1
Disassembly 1 1
Contamination 1 1
Crack 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Mechanical Problem 1 1
Material Frayed 1 1
Hole In Material 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 1230 1230
Erosion 698 698
Incontinence 578 578
Injury 427 427
Urinary Tract Infection 289 289
Urinary Retention 275 275
Unspecified Infection 269 269
No Code Available 226 226
Micturition Urgency 196 196
Dysuria 159 159
Dyspareunia 151 151
Urinary Frequency 147 147
Urinary Incontinence 137 137
No Clinical Signs, Symptoms or Conditions 131 131
No Information 127 127
Hemorrhage/Bleeding 125 125
Prolapse 123 123
Surgical procedure 103 103
Insufficient Information 100 100
Death 99 99
Discomfort 96 96
Scar Tissue 92 92
Inflammation 89 89
Abnormal Vaginal Discharge 89 89
Scarring 86 86
Abdominal Pain 84 84
No Consequences Or Impact To Patient 84 84
Emotional Changes 81 81
No Known Impact Or Consequence To Patient 80 80
Not Applicable 77 77
Hematuria 76 76
Blood Loss 66 66
Constipation 62 62
Other (for use when an appropriate patient code cannot be identified) 61 61
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 54 54
Complaint, Ill-Defined 47 47
Foreign Body Reaction 47 47
Burning Sensation 46 46
Obstruction/Occlusion 41 41
Internal Organ Perforation 40 40
Perforation 38 38
Intermenstrual Bleeding 36 36
Bacterial Infection 34 34
Fistula 33 33
Tissue Damage 33 33
Nerve Damage 30 30
Laceration(s) 29 29
Cramp(s) /Muscle Spasm(s) 29 29
Foreign Body In Patient 29 29
Depression 28 28
Edema 27 27
Nausea 26 26
Genital Bleeding 26 26
Muscle Weakness 24 24
Adhesion(s) 24 24
Abscess 23 23
Disability 23 23
Unspecified Kidney or Urinary Problem 22 22
Wound Dehiscence 21 21
Hematoma 21 21
Muscle Spasm(s) 21 21
Failure of Implant 20 20
Fever 20 20
Device Embedded In Tissue or Plaque 20 20
Deformity/ Disfigurement 20 20
Anxiety 20 20
Fatigue 17 17
Bleeding 17 17
Itching Sensation 17 17
Pocket Erosion 17 17
Skin Erosion 17 17
Swelling 16 16
Unspecified Mental, Emotional or Behavioural Problem 16 16
Vomiting 15 15
Discharge 14 14
Numbness 14 14
Kidney Infection 13 13
Fibrosis 13 13
Sexual Dysfunction 13 13
Sepsis 13 13
Abrasion 13 13
Hypersensitivity/Allergic reaction 12 12
Swelling/ Edema 12 12
Patient Problem/Medical Problem 12 12
Fungal Infection 12 12
Neurological Deficit/Dysfunction 11 11
Irritation 10 10
Cyst(s) 10 10
Sleep Dysfunction 10 10
Fecal Incontinence 10 10
Distress 9 9
Diarrhea 9 9
Anemia 9 9
Calcium Deposits/Calcification 9 9
Therapeutic Response, Decreased 8 8
Abdominal Cramps 8 8
Skin Inflammation/ Irritation 8 8
Unspecified Tissue Injury 7 7
Granuloma 7 7
Headache 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Astora II Nov-16-2015
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