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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device endovascular suturing system
Regulation Description Endovascular Suturing System.
Definition Provides fixation and sealing between and endovascular graft and the native artery.
Product CodeOTD
Regulation Number 870.3460
Device Class 2


Premarket Reviews
ManufacturerDecision
APTUS ENDOSYSTEMS, INC.
  GRANTED 1
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Leak 65
No Known Device Problem 33
Break 13
Dislodged or dislocated 12
Device Difficult to Setup or Prepare 6
Material deformation 3
Packaging issue 2
Positioning Issue 2
Deployment issue 2
Device operates differently than expected 2
Device or device component damaged by another device 1
Device expiration issue 1
Difficult to insert 1
Inability to irrigate 1
Air leak 1
Foreign material present in device 1
Delivered as unsterile product 1
Total Device Problems 147

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