GRAFTMASTER
Received Jan 27, 2025 · Event occurred Apr 2, 2024
Report 2024168-2025-00855 · MDR key 21241058
Device
Generic name
Coronary Stent Delivery System
Manufacturer
Abbott Vascular Inc.Model number
1012817-19Catalog number
1012817-19
Lot number
2111441
Product problems
- Failure to Advance
- Failure to Advance
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY. THE 2.80X19MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO COVER A PERFORATION HOWEVER FAILED TO CROSS THE LESION AFTER SEVERAL ATTEMPTS. THE SDS WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER GRAFTMASTER. THERE WERE NO ADVERSE PATIENT EFFECTS 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.
Additional Manufacturer Narrative
VISUAL INSPECTION AND FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. 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, A DEFINITIVE CAUSE FOR THE REPORTED ISSUE COULD NOT BE DETERMINED. 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.
Description of Event or Problem
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT CIRCUMFLEX ARTERY. THE 2.80X19MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO COVER A PERFORATION HOWEVER FAILED TO CROSS THE LESION AFTER SEVERAL ATTEMPTS. THE SDS WAS REMOVED AND THE PROCEDURE COMPLETED WITH ANOTHER GRAFTMASTER. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS NOTED THE STENT WAS DISLODGED. FOLLOW UP CONFIRMED THE DISLODGEMENT WAS DUE TO HANDLING POST PROCEDURE.