ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Report
- Report Number
- 2124215-2026-23800
- Event Type
- Death
- Date Received
- May 1, 2026
- Date of Event
- January 1, 2016
- Report Date
- May 27, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- MCX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B2 DATE OF DEATH: UNKNOWN. B3 DATE OF EVENT: EARLIEST POSSIBLE DATE OF EVENT AS THE PATIENTS UNDERWENT ROTATIONAL ATHERECTOMY JANUARY 2016 TO DECEMBER 2022. 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. ZHOU, TINGQUAN ET AL. CLINICAL OUTCOMES OF ROTATIONAL ATHERECTOMY FOLLOWED BY CUTTING BALLOON FOR CALCIFIED CORONARY LESIONS. CORONARY ARTERY DISEASE VOL. 36,6 (2025): 496-503. DOI:10.1097/MCA.0000000000001515. INVESTIGATION RESULTS: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS. 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: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT AND THE CORRESPONDING LABELING, THE REPORTED ALLEGATION IS A WELL-KNOWN RISK RELATED TO THE USE OF THE DEVICE OR THE PROCEDURE. THE INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE WAS SELECTED. THERE WERE NO DEVICE PERFORMANCE ALLEGATIONS MADE WITHIN THE REPORTED EVENTS.
B2 DATE OF DEATH: UNKNOWN. B3 DATE OF EVENT: EARLIEST POSSIBLE DATE OF EVENT AS THE PATIENTS UNDERWENT ROTATIONAL ATHERECTOMY JANUARY 2016 TO DECEMBER 2022. 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. ZHOU, TINGQUAN ET AL. CLINICAL OUTCOMES OF ROTATIONAL ATHERECTOMY FOLLOWED BY CUTTING BALLOON FOR CALCIFIED CORONARY LESIONS. CORONARY ARTERY DISEASE VOL. 36,6 (2025): 496-503. DOI:10.1097/MCA.0000000000001515.
IT WAS REPORTED VIA LITERATURE THAT DEATH OCCURRED. THIS SINGLE-CENTER, RETROSPECTIVE COHORT STUDY INCLUDED 326 PATIENTS WITH SEVERE CORONARY ARTERY CALCIFICATION WHO UNDERWENT ROTATIONAL ATHERECTOMY WITH BURR SIZES OF 1.25, 1.5, OR 1.75 MM, AND A ROTATION SPEED OF 140 000 TO 210 000 RPM FOLLOWED BY PCI BETWEEN JANUARY 2016 AND DECEMBER 2022. PATIENTS WERE DIVIDED INTO TWO GROUPS ON THE BASIS OF PROCEDURAL CHARACTERISTICS: THE RACB GROUP, WHICH RECEIVED ROTATIONAL ATHERECTOMY AND CUTTING BALLOON PRETREATMENT OF SEVERELY CALCIFIED PLAQUES, AND THE RAPB GROUP, WHICH RECEIVED ROTATIONAL ATHERECTOMY AND PLAIN BALLOON (NONCOMPLIANT BALLOON) PRETREATMENT. AMONG THESE PATIENTS, 135 PATIENTS RECEIVED RACB, AND 191 RECEIVED RAPB. PROCEDURAL SUCCESS WAS DEFINED AS THE SUCCESSFUL USE OF THE ROTATIONAL ATHERECTOMY TO TREAT THE VESSEL AND ACHIEVE STENT IMPLANTATION. STENTS WERE IMPLANTED SUCCESSFULLY IN ALL PATIENTS. THE FOLLOW-UP DATA INCLUDED POSTPROCEDURAL OUTCOMES, SURVIVAL, AND THE INCIDENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE). THIS ENABLED THE EVALUATION OF BOTH SHORT-TERM AND LONG-TERM CLINICAL OUTCOMES IN THE TWO TREATMENT GROUPS. A MACE WAS DEFINED AS A COMPOSITE OF CARDIAC DEATH, MI, AND TARGET VESSEL REVASCULARIZATION (TVR). PROCEDURAL COMPLICATIONS WERE COMPARABLE BETWEEN THE TWO GROUPS. NO CASES OF EMERGENT CORONARY ARTERY BYPASS GRAFTING OR IN-HOSPITAL DEATHS OCCURRED IN EITHER GROUP. IN THE RACB GROUP, THERE WERE 2 OCCURRENCES OF NO/SLOW FLOW, 1 PERICARDIAL EFFUSION, 2 PERFORATIONS AND 3 MYOCARDIAL INFARCTIONS. IN THE RAPB GROUP, THERE WERE 3 OCCURRENCES OF NO/SLOW FLOW, 2 PERICARDIAL EFFUSION, 2 PERFORATIONS AND 6 MYOCARDIAL INFARCTIONS. THE 1 YEAR-FOLLOW UP CLINICAL OUTCOMES REVEALED 9 MACE, 1 CARDIAC DEATH, 1 MYOCARDIAL INFARCTION AND 1 TVR IN THE RACB GROUP. IN THE RAPB GROUP 31 MACE, 2 CARDIAC DEATH, 9 MYOCARDIAL INFARCTION AND 24 TVR OCCURRED. THE MAIN FINDINGS CAN BE SUMMARIZED AS FOLLOWS: FIRST, IN THE DES ERA, TREATING SEVERE CALCIFICATION WITH RACB IS BOTH SAFE AND EFFECTIVE. SECOND, IN TERMS OF CLINICAL OUTCOMES, THE MACE RATE FOR PATIENTS TREATED WITH RACB WAS LOWER THAN THAT FOR THOSE TREATED WITH RAPB AT THE 1-YEAR FOLLOW-UP. THESE FINDINGS SUGGEST THAT RACB MAY FACILITATE OPTIMAL STENT DEPLOYMENT AND IMPROVE CLINICAL OUTCOMES.
IT WAS REPORTED VIA LITERATURE THAT DEATH OCCURRED. THIS SINGLE-CENTER, RETROSPECTIVE COHORT STUDY INCLUDED 326 PATIENTS WITH SEVERE CORONARY ARTERY CALCIFICATION WHO UNDERWENT ROTATIONAL ATHERECTOMY WITH BURR SIZES OF 1.25, 1.5, OR 1.75 MM, AND A ROTATION SPEED OF 140 000 TO 210 000 RPM FOLLOWED BY PCI BETWEEN JANUARY 2016 AND DECEMBER 2022. PATIENTS WERE DIVIDED INTO TWO GROUPS ON THE BASIS OF PROCEDURAL CHARACTERISTICS: THE RACB GROUP, WHICH RECEIVED ROTATIONAL ATHERECTOMY AND CUTTING BALLOON PRETREATMENT OF SEVERELY CALCIFIED PLAQUES, AND THE RAPB GROUP, WHICH RECEIVED ROTATIONAL ATHERECTOMY AND PLAIN BALLOON (NONCOMPLIANT BALLOON) PRETREATMENT. AMONG THESE PATIENTS, 135 PATIENTS RECEIVED RACB, AND 191 RECEIVED RAPB. PROCEDURAL SUCCESS WAS DEFINED AS THE SUCCESSFUL USE OF THE ROTATIONAL ATHERECTOMY TO TREAT THE VESSEL AND ACHIEVE STENT IMPLANTATION. STENTS WERE IMPLANTED SUCCESSFULLY IN ALL PATIENTS. THE FOLLOW-UP DATA INCLUDED POSTPROCEDURAL OUTCOMES, SURVIVAL, AND THE INCIDENCE OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE). THIS ENABLED THE EVALUATION OF BOTH SHORT-TERM AND LONG-TERM CLINICAL OUTCOMES IN THE TWO TREATMENT GROUPS. A MACE WAS DEFINED AS A COMPOSITE OF CARDIAC DEATH, MI, AND TARGET VESSEL REVASCULARIZATION (TVR). PROCEDURAL COMPLICATIONS WERE COMPARABLE BETWEEN THE TWO GROUPS. NO CASES OF EMERGENT CORONARY ARTERY BYPASS GRAFTING OR IN-HOSPITAL DEATHS OCCURRED IN EITHER GROUP. IN THE RACB GROUP, THERE WERE 2 OCCURRENCES OF NO/SLOW FLOW, 1 PERICARDIAL EFFUSION, 2 PERFORATIONS AND 3 MYOCARDIAL INFARCTIONS. IN THE RAPB GROUP, THERE WERE 3 OCCURRENCES OF NO/SLOW FLOW, 2 PERICARDIAL EFFUSION, 2 PERFORATIONS AND 6 MYOCARDIAL INFARCTIONS. THE 1 YEAR-FOLLOW UP CLINICAL OUTCOMES REVEALED 9 MACE, 1 CARDIAC DEATH, 1 MYOCARDIAL INFARCTION AND 1 TVR IN THE RACB GROUP. IN THE RAPB GROUP 31 MACE, 2 CARDIAC DEATH, 9 MYOCARDIAL INFARCTION AND 24 TVR OCCURRED. THE MAIN FINDINGS CAN BE SUMMARIZED AS FOLLOWS: FIRST, IN THE DES ERA, TREATING SEVERE CALCIFICATION WITH RACB IS BOTH SAFE AND EFFECTIVE. SECOND, IN TERMS OF CLINICAL OUTCOMES, THE MACE RATE FOR PATIENTS TREATED WITH RACB WAS LOWER THAN THAT FOR THOSE TREATED WITH RAPB AT THE 1-YEAR FOLLOW-UP. THESE FINDINGS SUGGEST THAT RACB MAY FACILITATE OPTIMAL STENT DEPLOYMENT AND IMPROVE CLINICAL OUTCOMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 482223 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM | CATHETER, CORONARY, ATHERECTOMY | MCX | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |