PROMUS PREMIER
Report
- Report Number
- 2124215-2024-79103
- Event Type
- Malfunction
- Date Received
- December 20, 2024
- Date of Event
- November 29, 2024
- Report Date
- June 11, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5: DESCRIBE EVENT OR PROBLEM UPDATED. H6: DEVICE CODE CORRECTED FROM FRACTURE A040101 TO MATERIAL DEFORMATION A0406. E1: INITIAL REPORTER PHONE: (B)(6).
DEVICE EVALUATED BY MANUFACTURER: PROMUS PREMIER OUS MR 28 X 2.75MM STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. VISUAL, TACTILE AND MICROSCOPIC ANALYSIS WAS PERFORMED ON THE DEVICE. NO DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS. B5: DESCRIBE EVENT OR PROBLEM UPDATED. H6: DEVICE CODE CORRECTED FROM FRACTURE A040101 TO MATERIAL DEFORMATION A0406 E1: INITIAL REPORTER PHONE: (B)(6).
DEVICE EVALUATED BY MANUFACTURER: PROMUS PREMIER OUS MR 28 X 2.75MM STENT DELIVERY SYSTEM (SDS) WAS RETURNED FOR ANALYSIS. VISUAL, TACTILE AND MICROSCOPIC ANALYSIS WAS PERFORMED ON THE DEVICE. NO DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS. B5: DESCRIBE EVENT OR PROBLEM UPDATED. H6: DEVICE CODE CORRECTED FROM FRACTURE A040101 TO MATERIAL DEFORMATION A0406 E1: INITIAL REPORTER PHONE: (B)(6).
E1: INITIAL REPORTER PHONE: (B)(4).
IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF CIRCUMFLEX LIMB. A 28 X 2.75MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND DURING UNPACKING THAT THERE WAS DENATURATION AND DEVICE COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DEFORMED AND NOT FRACTURED AS WHAT WAS PREVIOUSLY REPORTED.
IT WAS REPORTED THAT STENT DEFORMATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF CIRCUMFLEX LIMB. A 28 X 2.75MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND DURING UNPACKING THAT THERE WAS DENATURATION AND DEVICE COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DEFORMED AND NOT FRACTURED AS WHAT WAS PREVIOUSLY REPORTED.
IT WAS REPORTED THAT STENT DEFORMATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF CIRCUMFLEX LIMB. A 28 X 2.75MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND DURING UNPACKING THAT THERE WAS DENATURATION AND DEVICE COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE DEVICE WAS DEFORMED AND NOT FRACTURED AS WHAT WAS PREVIOUSLY REPORTED. IT WAS FURTHER REPORTED THAT THE ACTUAL ISSUE WAS A FAILURE TO CROSS LESION.
IT WAS REPORTED THAT STENT FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE PROXIMAL SEGMENT OF CIRCUMFLEX LIMB. A 28 X 2.75MM PROMUS PREMIER DRUG-ELUTING STENT WAS SELECTED FOR USE. HOWEVER, IT WAS FOUND DURING UNPACKING THAT THERE WAS DENATURATION AND DEVICE COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2328661 | PROMUS PREMIER | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC CORPORATION | 9552 | 0033962345 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female |