AVEIR¿ RETRIEVAL SYSTEM CATHETER

Additional Manufacturer Narrative

FURTHER INFORMATION WAS REQUESTED BUT NOT RECEIVED. D4 - PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER CANNOT BE PROVIDED AS A PRODUCT IDENTIFIER COULD NOT BE OBTAINED.

Description of Event or Problem

IT WAS REPORTED THAT AFTER THE LEADLESS (LP) PACEMAKER IMPLANT WAS COMPLETED, THE PATIENT EXPERIENCED CARDIAC ARREST RESULTING IN PULSELESS HEART ACTIVITY. A THORACOTOMY AND CARDIAC MASSAGE WERE PERFORMED. DURING THE CARDIAC MASSAGE, THE LP DISLODGED AND MIGRATED TO THE PULMONARY ARTERY. THE LP WAS UNABLE TO BE RETRIEVED WITH A RETRIEVAL CATHETER DUE TO A STRETCHED HELIX. THE PACEMAKER WAS SURGICALLY REMOVED. THE PATIENT WAS ALERT WITH NORMAL VITAL SIGNS FOLLOWING THE PROCEDURE, HOWEVER, PASSED AWAY A FEW DAYS LATER. THE PHYSICIAN ALLEGED THE PATIENT PASSED AWAY DUE TO A PULMONARY EMBOLISM AND THE PROCEDURE TIME MAY HAVE CONTRIBUTED TO THE PATIENT'S PASSING. THE PHYSICIAN ALLEGED THAT THE ABBOTT PRODUCTS USED WERE NOT RELATED TO THE CARDIAC ARREST OR THE PATIENT DEATH. ADDITIONALLY, IT WAS STATED THAT THE PATIENT EXPERIENCED A PLEURAL EFFUSION. IT IS UNKNOWN IF THE PULMONARY EMBOLISM OR PLEURAL EFFUSION WAS RELATED TO THE ABBOTT PRODUCTS OR THE PROCEDURE.

Additional Manufacturer Narrative

A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.