GRAFTMASTER
Received Mar 20, 2025 · Event occurred Feb 24, 2025
Report 2024168-2025-02897 · MDR key 21653316
Device
Generic name
Coronary Stent Delivery System
Manufacturer
Abbott Vascular Inc.Model number
1012818-19Catalog number
1012818-19
Lot number
3032441
Product problems
- Failure to Advance
- Failure to Advance
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO OPERATIONAL CONTEXT. IT WAS REPORTED THAT THE GRAFTMASTER WAS ATTEMPTED TO BE USED; HOWEVER, FAILED TO CROSS THE LESION. IT IS LIKELY THAT THE INTERACTION WITH THE HEAVILY CALCIFIED AND TORTUOUS LESION CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.
Description of Event or Problem
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 3.5X19MM GRAFTMASTER WAS ATTEMPTED TO BE USED; HOWEVER, THE GRAFMASTER FAILED TO CROSS THE LESION. THEREFORE, THE DEVICE WAS SIMPLY REMOVED AND THE LESION WAS TREATED VIA SURGERY INSTEAD OF STENTING. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
H11: SUBSEQUENT TO FILING INITIAL REPORT, UPDATE TO B5 - EVENT DETAILS, TO REFLECT USE OF THE GRAFTMASTER WAS FOR TREATMENT OF THE PERFORATION.
Description of Event or Problem
SUBSEQUENT TO FILING THE INITIAL REPORT, UPDATE TO EVENT DETAILS: IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT CIRCUMFLEX CORONARY ARTERY. A 3.5X19MM GRAFTMASTER WAS ATTEMPTED TO BE USED; HOWEVER, THE GRAFTMASTER FAILED TO CROSS THE LESION TO TREAT A PERFORATION. THEREFORE, THE DEVICE WAS SIMPLY REMOVED AND THE LESION WAS TREATED VIA SURGERY INSTEAD OF STENTING. THERE WERE NO ADVERSE PATIENT SEQUELA NOR CLINICAL DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.