GRAFTMASTER
Received Nov 11, 2024 · Event occurred Oct 10, 2024
Report 2024168-2024-13313 · MDR key 20658266
Device
Generic name
Coronary Stent Delivery System
Manufacturer
Abbott Vascular Inc.Model number
1012817-16CCatalog number
1012817-16C
Lot number
4021441
Product problems
- Material Separation
- Failure to Advance
- Material Separation
- Failure to Advance
Patient
71 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, PERFORATED LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. THE 2.80X16MM GRAFTMASTER STENT COVER FAILED TO CROSS DUE TO ANATOMY. ANOTHER GRAFTMASTER STENT COVER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENTLY, AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, IT WAS NOTED THAT THE TIP OF THE GRAFTMASTER SEPARATED DURING THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
VISUAL INSPECTION, FUNCTIONAL TESTING AND DIMENSIONAL ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE REPORTED TIP SEPARATION WAS CONFIRMED. THE REPORTED FAILURE TO ADVANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS RELATED TO OPERATIONAL CONTEXT OF THE PROCEDURE. 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 REPORTED INFORMATION AND THE OBSERVATIONS FROM THE RETURNED ANALYSIS, THE INVESTIGATION DETERMINED THAT THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED TIP SEPARATION. 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.
Additional Manufacturer Narrative
MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A MODERATELY CALCIFIED, MILDLY TORTUOUS, PERFORATED LEFT CIRCUMFLEX CORONARY ARTERY THAT IS 90% STENOSED. THE 2.80X16MM GRAFTMASTER STENT COVER FAILED TO CROSS DUE TO ANATOMY. ANOTHER GRAFTMASTER STENT COVER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.