GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM
Report
- Report Number
- 2024168-2021-11636
- Event Type
- Malfunction
- Date Received
- December 15, 2021
- Date of Event
- November 25, 2021
- Report Date
- January 20, 2022
- Manufacturer
- ABBOTT VASCULAR
- Product Code
- MAF
- UDI-DI
- 08717648176418
- PMA / PMN Number
- H000001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED MATERIAL SEPARATION AND DEFORMATION DUE TO COMPRESSIVE STRESS WAS CONFIRMED. 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 IDENTIFIED NO SIMILAR INCIDENTS FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.D1;D4; REPORTED DEVICE: RX GRAFTMASTER, 3.50MM X 26MM, PART# 1012581-26, LOT# 0083141 ACTUAL RETURNED DEVICE: GRAFTMASTER RX 2.80 X 26 AND LOT# 1012541.
PATIENT INFORMATION UPDATED.
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PERFORATION. THE 3.50X26MM RX GRAFTMASTER STENT DELIVERY SYSTEM (SDS) WAS ADVANCED HOWEVER BEFORE EXITING THE GUIDE, THE PROXIMAL SHAFT KINKED AND SEPARATED. THE SDS WAS SIMPLY REMOVED FROM THE GUIDE WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH A NON-ABBOTT DEVICE HOWEVER THE PATIENT EXPIRED. PER THE PHYSICIAN, THE PATIENT DEATH WAS NOT RELATED TO THE GRAFTMASTER DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.
SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED. THE 2.80X26MM GRAFTMASTER KINKED AND SEPARATED. A 3.50X26MM GRAFTMASTER WAS USED WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1912290 | GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM | CORONARY STENT DELIVERY SYSTEM | MAF | ABBOTT VASCULAR | 1012581-26 | 1012541 | 08717648176418 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Male |