PROMUS PREMIER
Report
- Report Number
- 2134265-2019-10445
- Event Type
- Death
- Date Received
- August 30, 2019
- Date of Event
- August 17, 2019
- Report Date
- May 19, 2020
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE IS A COMBINATION PRODUCT. DESCRIBE EVENT OR PROBLEM UPDATED.
DEVICE IS A COMBINATION PRODUCT.
PROMUS PREMIER CHINA REGISTRY CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION, HEART FAILURE OCCURRED AND PATIENT DIED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED THE TARGET LESION #1 LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 80% STENOSIS AND WAS 10MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50X12 MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS, AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75X16MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. TEN DAYS AFTER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2019, 93 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION WHICH LED TO THE PROLONGATION OF EXISTING HOSPITALIZATION. IT WAS NOTED THE EVENT LED TO THE SERIOUSNESS CRITERIA OF LIFE THREATENING ILLNESS/INJURY BUT WAS NOT MEDICALLY TREATED. FIVE DAYS LATER, THE SUBJECT PASSED AWAY. DEATH CERTIFICATE AND AUTOPSY REPORTS ARE NOT AVAILABLE FOR THE EVENT AT THE MOMENT. IT WAS FURTHER REPORTED TARGET LESION 1 EXTENDED FROM THE LMCA TO THE MID LAD, WHICH WAS ALSO TREATED WITH THE IMPLANTATION OF 2.75X16MM PROMUS PREMIER STENT.
PROMUS PREMIER CHINA REGISTRY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION, HEART FAILURE OCCURRED AND PATIENT DIED. ON (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED THE TARGET LESION #1 LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 80% STENOSIS AND WAS 10MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50X12 MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS, AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75X16MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. TEN DAYS AFTER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2019, 93 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION WHICH LED TO THE PROLONGATION OF EXISTING HOSPITALIZATION. IT WAS NOTED THE EVENT LED TO THE SERIOUSNESS CRITERIA OF LIFE THREATENING ILLNESS/INJURY BUT WAS NOT MEDICALLY TREATED. FIVE DAYS LATER, THE SUBJECT PASSED AWAY. DEATH CERTIFICATE AND AUTOPSY REPORTS ARE NOT AVAILABLE FOR THE EVENT AT THE MOMENT. IT WAS FURTHER REPORTED TARGET LESION 1 EXTENDED FROM THE LMCA TO THE MID LAD, WHICH WAS ALSO TREATED WITH THE IMPLANTATION OF 2.75X16MM PROMUS PREMIER STENT. IT WAS PREVIOUSLY REPORTED THAT TWO STENTS WERE IMPLANTED IN THE LMCA TO MID-LAD, BUT NOW IT IS REPORTED THE TARGET LESION WAS ONLY LOCATED IN THE LMCA AND WAS 10MM LONG. THE TARGET LESION WAS TREATED WITH ONE STENT, A 3.50X12MM PROMUS PREMIER STENT. AT THE TIME OF THE INDEX PROCEDURE, THE SUBJECT WAS ON PRIOR REGIMEN OF ASPIRIN AND P2Y12 AND RECEIVED HEPARIN AND ANTI-THROMBIN MEDICATION. ON (B)(6) 2019, DURING HOSPITALIZATION, THE PATIENT WAS NOTED WITH ELEVATION OF CARDIAC ENZYMES AND WAS DIAGNOSED WITH ACUTE NON-ST SEGMENT ELEVATION MYOCARDIAL INFARCTION (NSTEMI) WHICH WAS THE CAUSE OF DEATH.
DEVICE IS A COMBINATION PRODUCT.
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION, HEART FAILURE OCCURRED AND PATIENT DIED. IN (B)(6) 2019, THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED WHICH REVEALED THE TARGET LESION #1 LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 80% STENOSIS AND WAS 10MM LONG, WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50X12 MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. THE TARGET LESION #2 WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS, AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50MM. THE TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75X16MM STUDY STENT. FOLLOWING POST-DILATATION, THE RESIDUAL STENOSIS WAS 0%. TEN DAYS AFTER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2019, 93 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION WHICH LED TO THE PROLONGATION OF EXISTING HOSPITALIZATION. IT WAS NOTED THE EVENT LED TO THE SERIOUSNESS CRITERIA OF LIFE THREATENING ILLNESS/INJURY BUT WAS NOT MEDICALLY TREATED. FIVE DAYS LATER, THE SUBJECT PASSED AWAY. DEATH CERTIFICATE AND AUTOPSY REPORTS ARE NOT AVAILABLE FOR THE EVENT AT THE MOMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 742698 | PROMUS PREMIER | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC CORPORATION | 9548 | 0022149585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Death |