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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device syringe, balloon inflation
Product CodeMAV
Regulation Number 870.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
MEDTRONIC VASCULAR
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 199 199
2020 101 101
2021 186 186
2022 437 437
2023 220 220
2024 412 413

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 1070 1070
Loose or Intermittent Connection 209 209
Display or Visual Feedback Problem 171 171
Break 113 113
Physical Resistance/Sticking 48 48
Incorrect, Inadequate or Imprecise Result or Readings 47 48
Device Contamination with Chemical or Other Material 43 43
Inflation Problem 24 24
Material Separation 20 20
Unsealed Device Packaging 17 17
Tear, Rip or Hole in Device Packaging 15 15
Improper or Incorrect Procedure or Method 14 14
Packaging Problem 11 11
Appropriate Term/Code Not Available 10 10
Deflation Problem 9 9
Noise, Audible 8 8
Product Quality Problem 8 8
Material Integrity Problem 8 8
Device Contaminated During Manufacture or Shipping 7 7
Defective Device 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Shipping Damage or Problem 6 6
Crack 6 6
Mechanical Problem 6 6
Contamination 5 5
Pressure Problem 5 5
Detachment of Device or Device Component 4 4
Suction Problem 4 4
Obstruction of Flow 3 3
Failure to Zero 3 3
Unstable 3 3
Contamination /Decontamination Problem 2 2
Difficult to Remove 2 2
Insufficient Information 2 2
Device Sensing Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Connection Problem 2 2
Mechanical Jam 2 2
No Pressure 1 1
Use of Device Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Material Rupture 1 1
Device Damaged Prior to Use 1 1
Output Problem 1 1
Retraction Problem 1 1
Low Readings 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1
Material Split, Cut or Torn 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1227 1228
No Consequences Or Impact To Patient 267 267
No Patient Involvement 18 18
Insufficient Information 14 14
No Known Impact Or Consequence To Patient 13 13
Air Embolism 7 7
Arrhythmia 3 3
Vascular Dissection 3 3
Cardiac Arrest 3 3
Laceration(s) 3 3
Hemorrhage/Bleeding 3 3
Low Blood Pressure/ Hypotension 3 3
Death 2 2
Bradycardia 2 2
Perforation 1 1
Ventricular Fibrillation 1 1
Thrombosis/Thrombus 1 1
Perforation of Vessels 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Apr-13-2022
2 Abbott Vascular II Feb-27-2019
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