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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temporary coil embolization assist device
Regulation Description Temporary coil embolization assist device.
Definition A temporary coil embolization assist device is a prescription device intended for temporary use in the neurovasculature to mechanically assist in the embolization of intracranial aneurysms with embolic coils. The device is delivered into the neurovasculature with an endovascular approach. This device is not intended to be permanently implanted and is removed from the body when the procedure is completed.
Product CodePUU
Regulation Number 882.5955
Device Class 2

MDR Year MDR Reports MDR Events
2021 5 5
2022 6 6
2023 7 7
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Mechanical Problem 1 1
Separation Failure 1 1
Unintended Movement 1 1
Obstruction of Flow 1 1
Device Damaged by Another Device 1 1
Migration 1 1
Unintended Collision 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aneurysm 9 9
Thrombosis/Thrombus 3 3
Stroke/CVA 2 2
Obstruction/Occlusion 2 2
Laceration(s) 2 2
Hemorrhage/Bleeding 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Foreign Body In Patient 1 1
Failure to Anastomose 1 1
Device Embedded In Tissue or Plaque 1 1

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