ORISE GEL

Additional Manufacturer Narrative

BLOCK B3: THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE DATE THAT THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D4 AND H4: THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. BLOCK G3: LITERATURE SOURCE JOURNAL ARTICLE: REX DK, LAHR RE. THE DEMISE OF ORISE, A SUBMUCOSAL LIFTING AGENT FOR ENDOSCOPIC RESECTION. AME CASE REP 2023;7:11. DOI: 10.21037/ACR-23-15 BLOCK H6: IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION.

Description of Event or Problem

BOSTON SCIENTIFIC CORPORATION BECAME AWARE OF AN EVENT RELATED TO ORISE GEL FROM AN EDITORIAL ''THE DEMISE OF ORISE, A SUBMUCOSAL LIFTING AGENT FOR ENDOSCOPIC RESECTION'' WRITTEN BY DOUGLAS REX., MD AND RACHEL LAHR. THE ARTICLE MENTIONS A MONTHLY LIVE WEB-BASED COURSE ON ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURES BROADCASTED FROM THE AUTHOR'S CENTER, WHERE AN UNKNOWN PHYSICIAN DESCRIBES A RELATED STORY FROM THEIR HOME INSTITUTION. THE CASE INVOLVED SUBMUCOSAL DISTORTION OBSERVED IN A RECTAL EMR SCAR FOLLOWING THE USE OF ORISE INJECTION. THIS DISTORTION RAISED CONCERNS ABOUT POTENTIAL SUBMUCOSAL TUMOR GROWTH, LEADING TO SURGICAL RESECTION. HOWEVER, THE RESECTED SPECIMEN DID NOT SHOW ANY CANCEROUS GROWTH, BUT RATHER EXHIBITED AN ACCUMULATION OF EOSINOPHILIC MATERIAL AND MULTI-NUCLEATED GIANT CELLS, INDICATIVE OF AN ORISE REACTION. THESE CHANGES, KNOWN AS ''LIFTING GRANULOMA,'' HIGHLIGHT THE SIGNIFICANCE OF SUBMUCOSAL DISTORTION IN EMR SCARS, AS IT CAN HAVE IMPORTANT ADVERSE CLINICAL OUTCOMES.