PROMUS PREMIER
Report
- Report Number
- 2124215-2024-56071
- Event Type
- Death
- Date Received
- September 11, 2024
- Date of Event
- December 22, 2022
- Report Date
- November 14, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
E1: INITIAL REPORTER ADDRESS 1: (B)(6).
E1: INITIAL REPORTER ADDRESS 1: (B)(6).
E1: INITIAL REPORTER ADDRESS 1: (B)(6). E1 INITIAL REPORTER PHONE: (B)(6).
PROMUS PREMIER CHINA REGISTRY IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2019, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION #1 WAS LOCATED IN THE MIDDLE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80 % STENOSIS AND WAS 64 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 3.50 MM X 38 MM AND 4.00 MM X 32 MM PROMUS PREMIER STENT SYSTEMS. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE TARGET LESION #2 WAS LOCATED IN PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 70 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 4.00 MM X 16 MM PROMUS PREMIER STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE TARGET LESION #3 WAS LOCATED IN LMCA WITH 70 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #3 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 4.00 MM X 16 MM PROMUS PREMIER STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. FOUR DAYS POST PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2022, THE SUBJECT DIED. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ACTION WAS TAKEN TO TREAT THE EVENT AND IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED.
PROMUS PREMIER CHINA REGISTRY: IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2019, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION #1 WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) EXTENDING UP TO MIDDLE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80 % STENOSIS AND WAS 64 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 3.50 MM X 38 MM AND 4.00 MM X 32 MM PROMUS PREMIER STENT SYSTEMS. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE TARGET LESION #2 WAS LOCATED IN PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 70 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 4.00 MM X 16 MM PROMUS PREMIER STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE TARGET LESION #3 WAS LOCATED IN LMCA WITH 70 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #3 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 4.00 MM X 16 MM PROMUS PREMIER STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. FOUR DAYS POST PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2022, THE SUBJECT DIED. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ACTION WAS TAKEN TO TREAT THE EVENT AND IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS FURTHER REPORTER THAT TARGET LESION #1 WAS LOCATED IN THE MID LAD. IT WAS FURTHER REPORTED THAT THE TARGET LESION #3 WAS LOCATED IN LMCA EXTENDING UP TO PROXIMAL LAD AND WAS 32MM LONG. THE TARGET LESION# 3 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 4.00 MM X 32 MM PROMUS PREMIER STENT SYSTEM AND NOT 4.00 X16 MM PROMUS PREMIER STENT SYSTEM AS WHAT WAS PREVIOUSLY REPORTED. IT WAS FURTHER REPORTED THAT THE DIAMETER OF THE TARGET LESION #1 (MID LAD) WAS 38 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION# 1 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 3.50 MM X 38 MM. A 4.00 MM X 32 MM STENT WAS NOT IMPLANTED AS PREVIOUSLY REPORTED; THE SUBJECT ONLY HAD THREE STENTS IMPLANTED AT THE INDEX PROCEDURE.
PROMUS PREMIER CHINA REGISTRY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2019, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION #1 WAS LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) EXTENDING UP TO MIDDLE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80 % STENOSIS AND WAS 64 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 3.50 MM X 38 MM AND 4.00 MM X 32 MM PROMUS PREMIER STENT SYSTEMS. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE TARGET LESION #2 WAS LOCATED IN PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 70 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 4.00 MM X 16 MM PROMUS PREMIER STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. THE TARGET LESION #3 WAS LOCATED IN LMCA WITH 70 % STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4.0 MM. THE TARGET LESION #3 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 4.00 MM X 16 MM PROMUS PREMIER STENT SYSTEM. FOLLOWING POST DILATION, THE RESIDUAL STENOSIS WAS NOTED TO BE 10%. FOUR DAYS POST PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2022, THE SUBJECT DIED. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ACTION WAS TAKEN TO TREAT THE EVENT AND IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED. IT WAS FURTHER REPORTER THAT TARGET LESION #1 WAS LOCATED IN THE MID LAD. IT WAS FURTHER REPORTED THAT THE TARGET LESION #3 WAS LOCATED IN LMCA EXTENDING UP TO PROXIMAL LAD AND WAS 32MM LONG. THE TARGET LESION# 3 WAS TREATED WITH PRE-DILATION AND FOLLOWED BY THE PLACEMENT OF A 4.00 MM X 32 MM PROMUS PREMIER STENT SYSTEM AND NOT 4.00 X16 MM PROMUS PREMIER STENT SYSTEM AS WHAT WAS PREVIOUSLY REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 557565 | PROMUS PREMIER | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC CORPORATION | 9554 | 0022544421 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Male | Death |