PRESSUREWIRE¿

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION RECEIVED, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE WHICH RESULTED IN VASCULAR DISSECTION AND UNEXPECTED MEDICAL INTERVENTION APPEARS TO BE RELATED TO OPERATIONAL CONTEXT. IN THIS CASE, IT IS LIKELY THAT THE USE TECHNIQUES EMPLOYED WITH GUIDEWIRE DELIVERY, OR THE PATIENT¿S ANATOMICAL CONDITIONS, CAUSED THE REPORTED FAILURE TO ADVANCE VASCULAR DISSECTION AND UNEXPECTED MEDICAL INTERVENTION. THE REPORTED PATIENT EFFECTS (DISSECTION AND UNEXPECTED MEDICAL INTERVENTION) AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF DISSECTION IS LISTED IN THE PRESSUREWIRE INSTRUCTION FOR USE AS POTENTIAL COMPLICATIONS WHICH MAY BE ENCOUNTERED DURING ALL CATHETERIZATION PROCEDURES. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D9: CORRECTED DEVICE AVAILABLE FOR EVALUATION FROM YES TO NO

Description of Event or Problem

IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PRESSUREWIRE X (PWX) WAS ADVANCED HOWEVER FAILED TO CROSS THE LESION AND A DISSECTION OCCURRED. THE PWX WAS REMOVED AND A NON-ABBOTT GUIDE WIRE WAS ADVANCED AND A XIENCE ALPINE STENT WAS IMPLANTED TO TREAT THE DISSECTION. THERE WERE NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.