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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clip, aneurysm
Product CodeHCH
Regulation Number 882.5200
Device Class 2


Premarket Reviews
ManufacturerDecision
MIZUHO AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PETER LAZIC GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 9 9
2020 9 9
2021 13 13
2022 1 1
2023 10 10
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Seal 15 15
Mechanical Problem 6 6
Improper or Incorrect Procedure or Method 4 4
Material Integrity Problem 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Patient Device Interaction Problem 3 3
Difficult to Open or Close 3 3
Break 2 2
Material Twisted/Bent 2 2
Positioning Problem 2 2
Defective Component 2 2
Migration or Expulsion of Device 2 2
Device Difficult to Setup or Prepare 1 1
Product Quality Problem 1 1
Failure to Align 1 1
Failure to Form Staple 1 1
Component or Accessory Incompatibility 1 1
Insufficient Information 1 1
Difficult to Fold, Unfold or Collapse 1 1
Fracture 1 1
Material Deformation 1 1
Firing Problem 1 1
Activation Problem 1 1
Wrong Label 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
Insufficient Information 8 8
No Consequences Or Impact To Patient 8 8
No Known Impact Or Consequence To Patient 5 5
Aneurysm 5 5
Failure of Implant 2 2
Patient Problem/Medical Problem 2 2
Swelling 1 1
Foreign Body Reaction 1 1
Hemorrhage/Bleeding 1 1
No Code Available 1 1
Ruptured Aneurysm 1 1
Brain Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Peter Lazic Gmbh II Mar-12-2024
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