FDA Adverse Event Death Summary report: N

CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM

MDR report key: 10063511 · Received May 15, 2020

Report

Report Number
3004114958-2020-00002
Event Type
Death
Date Received
May 15, 2020
Date of Event
March 17, 2020
Report Date
May 15, 2020
Manufacturer
AESDEX, LLC
Product Code
FZP
UDI-DI
11814900000017
PMA / PMN Number
K091017
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
JA
Reporter Occupation
PHYSICIAN

Narratives

Description of Event or Problem · 1

THE PATIENT UNDERWENT AN OFF-PUMP CORONARY ARTERY BYPASS (OPCAB) DUE TO TRIPLE VESSEL CORONARY ARTERY DISEASE. AS PART OF THE PROCEDURE, THE SURGEON USED THE PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM (CLIP) WITH A SAPHENOUS VEIN GRAFT TO COMPLETE THE PROXIMAL ANASTOMOSIS OF A CORONARY ARTERY BYPASS. FOLLOWING DEPLOYMENT OF THE CLIP, THE SURGEON NOTED THE CLIP HAD PENETRATED THROUGH THE ANTERIOR WALL OF THE AORTA WHERE IT SHOULD HAVE BEEN AFFIXED, BUT RATHER WAS AFFIXED TO THE POSTERIOR WALL OF THE AORTA. BLEEDING WAS SEEN AT THE POSTERIOR WALL OF THE ASCENDING AORTA. THE SURGICAL STAFF MANUALLY STOPPED THE BLEEDING AND PLACED THE PATIENT ON CARDIOPULMONARY BYPASS TO REMOVE THE CLIP, REPAIR THE SITE OF BLEEDING, AND COMPLETE THE CORONARY ARTERY BYPASS SURGERY. SUBSEQUENTLY, BLEEDING WAS AGAIN NOTED FROM THE POSTERIOR WALL OF THE AORTA AND REQUIRED FURTHER REPAIR. THE PATIENT'S CONDITION BECAME UNSTABLE REQUIRING AN INTRA-AORTIC BALLOON PUMP AND PERCUTANEOUS CARDIOPULMONARY SUPPORT PRIOR TO COMPLETION OF THE SURGERY. ON (B)(6) 2020, THE PATIENT UNDERWENT FURTHER CHEST SURGERY FOR INCREASED BLEEDING FROM A SITE ASSOCIATED WITH USE OF A TEMPORARY PACEMAKER. NO BLEEDING WAS NOTED AT THE PREVIOUSLY REPAIRED AORTA. HOWEVER, THE PATIENT'S CONDITION DETERIORATED AND THE PATIENT SUBSEQUENTLY DIED DUE TO MULTI-ORGAN FAILURE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
525643 CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CLIP FZP AESDEX, LLC FG-000001 190614D 11814900000017

Patients

Seq Age Sex Outcome Treatment
1 68 YR Death| R