GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
Report
- Report Number
- 2024168-2021-12154
- Event Type
- Injury
- Date Received
- December 24, 2021
- Date of Event
- December 7, 2021
- Report Date
- February 18, 2022
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MAF
- PMA / PMN Number
- H000001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
A VISUAL AND DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED FAILURE TO ADVANCE COULD NOT BE TESTED AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT SPECIFIC QUALITY ISSUE. THE INVESTIGATION DETERMINED THE REPORTED FAILURE TO ADVANCE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.NA.
THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN A HEAVILY CALCIFIED, MILDLY TORTUOUS DE NOVO LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 2.80X19MM RX GRAFTMASTER FAILED TO CROSS DUE TO ANATOMY. ANOTHER SAME SIZE GRAFTMASTER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION IN A HEAVILY CALCIFIED, MILDLY TORTUOUS DE NOVO LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. THE 2.80X19MM RX GRAFTMASTER FAILED TO CROSS DUE TO ANATOMY. ANOTHER SAME SIZE GRAFTMASTER WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1982230 | GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM | CORONARY STENT DELIVERY SYSTEM | MAF | ABBOTT VASCULAR | 1033041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |