RIGIFLEX II

Description of Event or Problem

BOSTON SCIENTIFIC BECAME AWARE OF AN EVENTS INVOLVING RIGIFLEX II BALLOONS THROUGH THE ARTICLE, THE EFFICACY OF PERORAL ENDOSCOPIC MYOTOMY VS PNEUMATIC DILATION AS TREATMENT FOR PATIENTS WITH ACHALASIA SUFFERING FROM PERSISTENT OR RECURRENT SYMPTOMS AFTER LAPAROSCOPIC HELLER MYOTOMY: A RANDOMIZED CLINICAL TRIAL, BY CAROLINE M. G. SALEH, ET AL. PER THE ARTICLE, BETWEEN JANUARY 2014 AND JUNE 2020, A STUDY OF 90 PATIENTS SUFFERING FROM SYMPTOMS AFTER LAPAROSCOPIC HELLER MYOTOMY UNDERWENT PNEUMATIC DILATIONS OR PER-ORAL ENDOSCOPIC MYOTOMY. THE RIGIFLEX II BALLOONS WERE USED IN THE PNEUMATIC DILATATION PROCEDURES AND THE FOLLOWING OCCURRED: CHRONIC SEVERE REFLUX SYMPTOMS TREATED WITH A TOUPET FUNDOPLICATION, RETROSTERNAL PAIN, PNEUMOPERITONEUM, SUBCUTANEOUS EMPHYSEMA, ALLERGIC REACTION, MILD BLEEDING MANAGED CONSERVATIVELY, AND OTHER NON-UPPER-GASTROINTESTINAL RELATED ADVERSE EVENTS. PLEASE SEE THE REFERENCE ARTICLE FOR FULL DETAILS.

Additional Manufacturer Narrative

BLOCK B3: THE EXACT DATE OF EVENT WAS NOT REPORTED. THE RETROSPECTIVE STUDY DATE JANUARY 1, 2014, IS USED FOR THE ESTIMATED DATE OF EVENT BETWEEN JANUARY 2014 AND JUNE 2020. BLOCK D4, H4: THE SUSPECT DEVICE LOT NUMBER AND UPN WERE NOT REPORTED. THEREFORE, THE UNIQUE IDENTIFIER (UDI) NUMBER, MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. BLOCK G2: LITERATURE SOURCE: CAROLINE SALEH, ET AL., "THE EFFICACY OF PERORAL ENDOSCOPIC MYOTOMY VS PNEUMATIC DILATION AS TREATMENT FOR PATIENTS WITH ACHALASIA SUFFERING FROM PERSISTENT OR RECURRENT SYMPTOMS AFTER LAPAROSCOPIC HELLER MYOTOMY: A RANDOMIZED CLINICAL TRIAL" DEPARTMENT OF GASTROENTEROLOGY AND HEPATOLOGY, AMSTERDAM UMC, UNIVERSITY OF AMSTERDAM, AMSTERDAM, THE NETHERLANDS, HTTPS://DOI.ORG/10.1053/J.GASTRO.2023.02.048. BLOCK H6: IMDRF PATIENT CODE E1025 CAPTURES THE REPORTABLE EVENT OF A CHRONIC ACID REFLUX. IMDRF PATIENT CODE E233001 CAPTURES THE REPORTABLE EVENT OF RETROSTERNAL PAIN. IMDRF PATIENT CODE E2114 CAPTURES THE REPORTABLE EVENT OF PNUEMOPERITONEUM. IMDRF PATIENT CODE E0743 CAPTURES THE REPORTABLE EVENT OF SUBCUTANEOUS EMPHYSEMA. IMDRF PATIENT CODE E0402 CAPTURES THE REPORTABLE EVENT OF ALLERGIC REACTION. IMDRF PATIENT CODE E2401 CAPTURES THE REPORTABLE EVENT OF NON-UPPER GASTROINTESTINAL ADVERSE EVENTS. IMDRF IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF RETREATMENT WITH PER-ORAL ENDOSCOPIC MYOTOMY. IMDRF IMPACT CODE F12 CAPTURES THE REPORTABLE EVENT OF SERIOUS INJURY/ILLNESS/IMPAIRMENT.