SYNERGY
Report
- Report Number
- 2124215-2026-23109
- Event Type
- Death
- Date Received
- April 29, 2026
- Date of Event
- May 14, 2025
- Report Date
- May 21, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIQ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
D4 UNIQUE IDENTIFIER: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. G2 REPORT SOURCE: KWON W, CHOI KH, SONG YB, LEE JM, PARK TK, YANG JH, HAHN JY, CHOI SH, LEE JH, KIM MC, LEE HJ, GWON HC. EFFECT OF OPERATOR EXPERIENCE PERFORMING ROTATIONAL ATHERECTOMY ON CLINICAL OUTCOMES AFTER PERCUTANEOUS CORONARY INTERVENTION. KOREAN CIRC J. 2025 AUG;55(8):672-684. HTTPS://DOI.ORG/10.4070/KCJ.2024.0318.
D4 UNIQUE IDENTIFIER: DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. G2 REPORT SOURCE: KWON W, CHOI KH, SONG YB, LEE JM, PARK TK, YANG JH, HAHN JY, CHOI SH, LEE JH, KIM MC, LEE HJ, GWON HC. EFFECT OF OPERATOR EXPERIENCE PERFORMING ROTATIONAL ATHERECTOMY ON CLINICAL OUTCOMES AFTER PERCUTANEOUS CORONARY INTERVENTION. KOREAN CIRC J. 2025 AUG;55(8):672-684. HTTPS://DOI.ORG/10.4070/KCJ.2024.0318. INVESTIGATION RESULTS: LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. RISK REVIEW: A RISK REVIEW WAS PERFORMED, AND IT CONFIRMED THAT THE EVENT WAS DEFINED IN THE RISK DOCUMENTATION AND IS RECORDED ACCORDINGLY IN THE PRODUCT RECORD REVIEW (PRR) TABLE. THIS EVENT TYPE HAS BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: THIS PRODUCT INVESTIGATION IS ASSIGNED THE MOST PROBABLE CAUSE CLASSIFICATION OF KNOWN INHERENT RISK OF DEVICE. THIS CODE WAS SELECTED AS THE MOST PROBABLE COMPLAINT CAUSE BASED ON THE LIMITED INFORMATION AVAILABLE. IT IS NOTED THAT THE EVENT OF DEATH IS LISTED IN THE PRODUCT'S LABELLED INDICATIONS FOR USE, AS A KNOWN ADVERSE EVENT ASSOCIATED WITH DEVICE USE. THE COMPLAINT DID NOT REPORT ANY DEVICE MALFUNCTIONS WHICH COULD HAVE CONTRIBUTED TO THE COMPLAINT.
IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DEATH OCCURRED. A COMPARISON WAS MADE BETWEEN OUTCOMES OF (ROTATIONAL ATHERECTOMY) RAS PERFORMED BY MORE EXPERIENCED AND LESS EXPERIENCED OPERATORS, DEFINED BY THE CUMULATIVE NUMBER OF RA PROCEDURES EACH OPERATOR HAS PERFORMED, TO INVESTIGATE WHETHER OPERATOR DIFFERENCES AFFECT CLINICAL OUTCOMES. THE SMART-RACE (SMART ANGIOPLASTY RESEARCH TEAM: COMPARISON BETWEEN ELECTIVE AND BAIL-OUT ROTATIONAL ATHERECTOMY FOR CALCIFIED LESION IN KOREA) REGISTRY IS A PROSPECTIVE, OPEN-LABEL, MULTICENTER, OBSERVATIONAL STUDY EVALUATING AND COMPARING THE IN-HOSPITAL AND LONG-TERM EFFICACY AND SAFETY OF RA. ENROLLMENT OCCURRED BETWEEN DECEMBER 2015 AND APRIL 2020, AND DATA WERE GATHERED FROM PATIENTS AGED 19 YEARS OR OLDER WHO UNDERWENT PCI WITH RA IN ANY OF 27 MEDICAL CENTERS IN KOREA. THE INCLUSION CRITERIA WERE PATIENTS WITH SEVERELY CALCIFIED LESIONS IN THEIR NATIVE CORONARY ARTERIES, PRESENTING WITH VISUALLY ESTIMATED DIAMETERS OF 2.25 TO 4.25 MM. A TOTAL OF 497 PATIENTS WERE ENROLLED IN THE STUDY. PATIENTS WERE SUBJECT TO FOLLOW-UP AT 1, 6, AND 12 MONTHS, WITH DOCUMENTATION OF THEIR FINAL STATUS AT THE 12-MONTH MARK. ADVERSE EVENTS THAT OCCURRED DURING THE INDEX PROCEDURE, HOSPITALIZATION, AND FOLLOW-UP WERE METICULOUSLY RECORDED. PATIENTS UNABLE TO ATTEND OUTPATIENT CLINICAL VISITS WERE CONTACTED VIA TELEPHONE OR EMAIL. MORTALITY DATA FOR PATIENTS LOST TO FOLLOW-UP WERE CONFIRMED BY NATIONAL DEATH RECORDS. PCI AND RA WERE CONDUCTED USING STANDARD TECHNIQUES ALIGNED WITH THE CLINICAL GUIDELINES OF THE TIME. ALL PATIENTS RECEIVED SECOND-GENERATION DRUG-ELUTING STENTS. THE USED DRUG-ELUTING STENTS WERE PLATINUM CHROMIUM EVEROLIMUS-ELUTING STENTS, PROMUS PREMIER OR SYNERGY. RA WAS CONDUCTED USING A ROTABLATOR AND THE BURR SIZE WAS RECOMMENDED TO ATTAIN A BURR-TO-VESSEL RATIO OF 0.5. THE ROTABLATION SPEED RANGED FROM 140,000 TO 180,000 ROTATIONS PER MINUTE, WITH HIGHER SPEEDS PERMITTED IF NECESSARY. THE BURR WAS POSITIONED IMMEDIATELY PROXIMAL TO THE LESION TO PREVENT INJURY TO THE HEALTHY VESSEL SEGMENT. AN INTRACORONARY INFUSION OF A MIXED SOLUTION OF HEPARIN, VERAPAMIL, AND NITROGLYCERIN WAS ADMINISTERED DURING EACH RA PROCEDURE. TEMPORARY PACEMAKER INSERTION DURING RA OF THE RIGHT CORONARY ARTERY AND THE LEFT CIRCUMFLEX ARTERY IN PATIENTS WITH A DOMINANT LEFT SYSTEM WAS PERFORMED AT THE OPERATOR'S DISCRETION. ALL OPERATORS HAD THEIR CERTIFICATION FROM THE KOREAN SOCIETY OF INTERVENTIONAL CARDIOLOGY AND HAD EXPERIENCE WITH AT LEAST 5 RA CASES AT THE BEGINNING OF THE STUDY. STANDARD PHARMACOLOGICAL THERAPY, BOTH BEFORE AND AFTER THE INDEX PROCEDURE, ADHERED TO CURRENT CLINICAL GUIDELINES.11)12) DUAL ANTIPLATELET THERAPY WAS RECOMMENDED FOR A MINIMUM OF 3 TO 6 MONTHS IN PATIENTS WITH STABLE ISCHEMIC HEART DISEASE AND 6 TO12 MONTHS IN THOSE WITH ACUTE CORONARY SYNDROME, REGARDLESS OF THE ALLOCATED ARMS. THE LOADING, MAINTENANCE DOSE, AND DURATION OF DUAL ANTIPLATELET THERAPY WERE ALL AT THE DISCRETION OF THE ATTENDING PHYSICIAN. THE PRIMARY ENDPOINT OF THE STUDY WAS MAJOR ADVERSE CARDIAC EVENTS (MACE), DEFINED AS A COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION, AND TARGET VESSEL REVASCULARIZATION WITHIN 1 YEAR. THE SECONDARY ENDPOINTS WERE THE INDIVIDUAL COMPONENTS OF MACE, ALL-CAUSE DEATH, STROKE, AND ANY REVASCULARIZATION AT THE 1-YEAR MARK. ALL DEATHS WERE PRESUMED TO BE CARDIAC RELATED UNLESS A DEFINITIVE NON-CARDIAC CAUSE WAS ESTABLISHED. IN PCI USING RA FOR CALCIFIED LESIONS, THE COMPOSITE OUTCOME OF CARDIAC DEATH, MYOCARDIAL INFARCTION, AND TARGET VESSEL REVASCULARIZATION AT 1 YEAR WAS NOT SIGNIFICANTLY DIFFERENT ACCORDING TO RA EXPERIENCE AMONG OPERATORS. BETWEEN THE TWO GROUPS THERE WAS 1 DEATH DURING THE PROCEDURE AND 25 DEATHS POST PROCEDURE.
IT WAS REPORTED VIA A JOURNAL ARTICLE THAT DEATH OCCURRED. A COMPARISON WAS MADE BETWEEN OUTCOMES OF (ROTATIONAL ATHERECTOMY) RAS PERFORMED BY MORE EXPERIENCED AND LESS EXPERIENCED OPERATORS, DEFINED BY THE CUMULATIVE NUMBER OF RA PROCEDURES EACH OPERATOR HAS PERFORMED, TO INVESTIGATE WHETHER OPERATOR DIFFERENCES AFFECT CLINICAL OUTCOMES. THE SMART-RACE (SMART ANGIOPLASTY RESEARCH TEAM: COMPARISON BETWEEN ELECTIVE AND BAIL-OUT ROTATIONAL ATHERECTOMY FOR CALCIFIED LESION IN KOREA) REGISTRY IS A PROSPECTIVE, OPEN-LABEL, MULTICENTER, OBSERVATIONAL STUDY EVALUATING AND COMPARING THE IN-HOSPITAL AND LONG-TERM EFFICACY AND SAFETY OF RA. ENROLLMENT OCCURRED BETWEEN DECEMBER 2015 AND APRIL 2020, AND DATA WERE GATHERED FROM PATIENTS AGED 19 YEARS OR OLDER WHO UNDERWENT PCI WITH RA IN ANY OF 27 MEDICAL CENTERS IN KOREA. THE INCLUSION CRITERIA WERE PATIENTS WITH SEVERELY CALCIFIED LESIONS IN THEIR NATIVE CORONARY ARTERIES, PRESENTING WITH VISUALLY ESTIMATED DIAMETERS OF 2.25-4.25 MM. A TOTAL OF 497 PATIENTS WERE ENROLLED IN THE STUDY. PATIENTS WERE SUBJECT TO FOLLOW-UP AT 1, 6, AND 12 MONTHS, WITH DOCUMENTATION OF THEIR FINAL STATUS AT THE 12-MONTH MARK. ADVERSE EVENTS THAT OCCURRED DURING THE INDEX PROCEDURE, HOSPITALIZATION, AND FOLLOW-UP WERE METICULOUSLY RECORDED. PATIENTS UNABLE TO ATTEND OUTPATIENT CLINICAL VISITS WERE CONTACTED VIA TELEPHONE OR EMAIL. MORTALITY DATA FOR PATIENTS LOST TO FOLLOW-UP WERE CONFIRMED BY NATIONAL DEATH RECORDS. PCI AND RA WERE CONDUCTED USING STANDARD TECHNIQUES ALIGNED WITH THE CLINICAL GUIDELINES OF THE TIME. ALL PATIENTS RECEIVED SECOND-GENERATION DRUG-ELUTING STENTS. THE USED DRUG-ELUTING STENTS WERE PLATINUM CHROMIUM EVEROLIMUS-ELUTING STENTS, PROMUS PREMIER OR SYNERGY. RA WAS CONDUCTED USING A ROTABLATOR AND THE BURR SIZE WAS RECOMMENDED TO ATTAIN A BURR-TO-VESSEL RATIO OF 0.5. THE ROTABLATION SPEED RANGED FROM 140,000 TO 180,000 ROTATIONS PER MINUTE, WITH HIGHER SPEEDS PERMITTED IF NECESSARY. THE BURR WAS POSITIONED IMMEDIATELY PROXIMAL TO THE LESION TO PREVENT INJURY TO THE HEALTHY VESSEL SEGMENT. AN INTRACORONARY INFUSION OF A MIXED SOLUTION OF HEPARIN, VERAPAMIL, AND NITROGLYCERIN WAS ADMINISTERED DURING EACH RA PROCEDURE. TEMPORARY PACEMAKER INSERTION DURING RA OF THE RIGHT CORONARY ARTERY AND THE LEFT CIRCUMFLEX ARTERY IN PATIENTS WITH A DOMINANT LEFT SYSTEM WAS PERFORMED AT THE OPERATOR'S DISCRETION. ALL OPERATORS HAD THEIR CERTIFICATION FROM THE KOREAN SOCIETY OF INTERVENTIONAL CARDIOLOGY AND HAD EXPERIENCE WITH AT LEAST 5 RA CASES AT THE BEGINNING OF THE STUDY. STANDARD PHARMACOLOGICAL THERAPY, BOTH BEFORE AND AFTER THE INDEX PROCEDURE, ADHERED TO CURRENT CLINICAL GUIDELINES. DUAL ANTIPLATELET THERAPY WAS RECOMMENDED FOR A MINIMUM OF 3-6 MONTHS IN PATIENTS WITH STABLE ISCHEMIC HEART DISEASE AND 6-12 MONTHS IN THOSE WITH ACUTE CORONARY SYNDROME, REGARDLESS OF THE ALLOCATED ARMS. THE LOADING, MAINTENANCE DOSE, AND DURATION OF DUAL ANTIPLATELET THERAPY WERE ALL AT THE DISCRETION OF THE ATTENDING PHYSICIAN. THE PRIMARY ENDPOINT OF THE STUDY WAS MAJOR ADVERSE CARDIAC EVENTS (MACE), DEFINED AS A COMPOSITE OF CARDIAC DEATH, MYOCARDIAL INFARCTION, AND TARGET VESSEL REVASCULARIZATION WITHIN 1 YEAR. THE SECONDARY ENDPOINTS WERE THE INDIVIDUAL COMPONENTS OF MACE, ALL-CAUSE DEATH, STROKE, AND ANY REVASCULARIZATION AT THE 1-YEAR MARK. ALL DEATHS WERE PRESUMED TO BE CARDIAC-RELATED UNLESS A DEFINITIVE NON-CARDIAC CAUSE WAS ESTABLISHED. IN PCI USING RA FOR CALCIFIED LESIONS, THE COMPOSITE OUTCOME OF CARDIAC DEATH, MYOCARDIAL INFARCTION, AND TARGET VESSEL REVASCULARIZATION AT 1 YEAR WAS NOT SIGNIFICANTLY DIFFERENT ACCORDING TO RA EXPERIENCE AMONG OPERATORS. BETWEEN THE TWO GROUPS THERE WAS 1 DEATH DURING THE PROCEDURE AND 25 DEATHS POST PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 401809 | SYNERGY | BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM | NIQ | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |