RIGIFLEX II

Description of Event or Problem

BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF MULTIPLE EVENTS THROUGH THE ARTICLE "OUTCOME OF SEQUENTIAL DILATATION IN ACHALASIA CARDIA PATIENTS: A PROSPECTIVE COHORT STUDY" WRITTEN BY DEBASHIS MISRA, ET AL. ACCORDING TO THE LITERATURE, BETWEEN SEPTEMBER 2019 AND JUNE 2020, 30 MM RIGIFLEX II BALLOONS WERE USED UNDER FLOUROSCOPIC GUIDANCE ACROSS THE GASTRO-ESOPHAGEAL JUNCTION AND INFLATED TO 20 PSI FOR 60 SECONDS IN 72 PATIENTS. THERE WERE 44 MALE AND 28 FEMALE PATIENTS, WITH A MEDIAN AGE OF 41.5 YEARS (RANGE, 18-70). ALL PATIENTS WERE MONITORED CLINICALLY FOR ANY MAJOR ADVERSE EVENTS AFTER EACH DILATION PROCEDURE. CLINICAL FOLLOW-UP WAS PERFORMED FOUR WEEKS AFTER THE INITIAL DILATION AND ADDITIONAL PNEUMATIC DILATIONS WERE PERFORMED, IF NECESSARY, WITH 35 OR 40 MM RIGIFLEX II BALLOONS. SOME PATIENTS CONTINUED FOLLOW-UP UNTIL THE END OF THE STUDY PERIOD (JUNE 2021). BALLOON RELATED ADVERSE EVENTS WERE OBSERVED IN THREE PATIENTS. IATROGENIC PERFORATION WAS NOTED IN TWO PATIENTS. ONE EACH EPISODE OCCURRED WITH 30 MM AND 35 MM BALLOON. BOTH WERE MANAGED SURGICALLY. ANOTHER PATIENT REQUIRED HOSPITAL ADMISSION FOR CHEST PAIN AFTER DILATATION WITH A 30 MM BALLOON. SUBSEQUENTLY, PERFORATION WAS RULED OUT.

Additional Manufacturer Narrative

BLOCK D4, H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE UPN AND LOT NUMBER. THEREFORE, THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. BLOCK E1: INITIAL REPORTER FACILITY NAME: THE INITIAL REPORTER FACILITY NAME IS INSTITUTE OF POSTGRADUATE MEDICAL EDUCATION AND RESEARCH (IPGMER). BLOCK G2: LITERATURE: MISRA, D, BANERJEE, A, DAS, KAUSIK, DAS, KSHAUNISH AND DHALI, KD (2022), OUTCOME OF SEQUENTIAL DILATATION IN ACHALASIA CARDIA PATIENTS: A PROSPECTIVE COHORT STUDY (2022) 19:508-515. DOI: 10.1007/S10388-021-00902-5. BLOCK H6: IMDRF PATIENT CODE E233001CAPTURES THE REPORTABLE EVENT OF CHEST PAIN.