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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
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Leak 84
No Known Device Problem 50
Break 22
Dislodged or dislocated 15
Device Difficult to Setup or Prepare 7
Deployment issue 5
Device operates differently than expected 3
Material deformation 3
Positioning Issue 3
Packaging issue 2
Air leak 1
Foreign material present in device 1
Incompatibility problem 1
Delivered as unsterile product 1
Device or device component damaged by another device 1
Device expiration issue 1
Difficult to insert 1
Inability to irrigate 1
Total Device Problems 202

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