ORISE GEL

Additional Manufacturer Narrative

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. THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. REPORT SOURCE: LITERATURE. THE CITATION IS BELOW. S. WASSIMI, A. CLEMENTS AND M. L. GUERRY-FOCE. CASE REPORT: A DIAGNOSTIC DILEMMA CAUSED BY THE PRESENCE OF ORISE GEL, WHEN NOT REMOVED WITH INITIAL ENDOSCOPIC EN-BLOC RESECTION [MEETING ABSTRACT]. FASEB JOURNAL. 2021; 35:SUPPL 1. (B)(4).

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON AN UNKNOWN DATE. ORISE GEL WAS REPORTED TO NOT BE RESECTED IN THE INITIAL POLYPECTOMY. IT IS UNKNOWN IF RESECTION WAS NOT ATTEMPTED AT ALL OR IF RESECTION OF THE LESION WAS PERFORMED WITH REMNANT ORISE GEL MATERIAL REMAINING POST-PROCEDURE. A GRANULOMA FORMATION WAS PRESENT BENEATH AN UNDERLYING TUBULAR ADENOMA ALONG WITH ORISE GEL. THIS APPEARED AS A MASS TO THE CLINICIAN. THE PATIENT UNDERWENT A SEGMENTAL TRANSVERSE COLON RESECTION. IT WAS REPORTED THAT THE PRESENCE OF ORISE GEL IN TISSUE, WHEN NOT FULLY RESECTED, SOMETIMES PRESENTS A DIAGNOSTIC DILEMMA TO THE CLINICIAN AS WELL AS THE PATHOLOGIST. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

Description of Event or Problem

IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT ORISE GEL WAS USED AS A LIFTING AGENT IN THE COLON DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE PERFORMED ON (B)(6) 2019. ORISE GEL WAS REPORTED TO NOT BE RESECTED IN THE INITIAL POLYPECTOMY. IT IS UNKNOWN IF RESECTION WAS NOT ATTEMPTED AT ALL OR IF RESECTION OF THE LESION WAS PERFORMED WITH REMNANT ORISE GEL MATERIAL REMAINING POST-PROCEDURE. A GRANULOMA FORMATION WAS PRESENT BENEATH AN UNDERLYING TUBULAR ADENOMA ALONG WITH ORISE GEL. THIS APPEARED AS A MASS TO THE CLINICIAN. THE PATIENT UNDERWENT A SEGMENTAL TRANSVERSE COLON RESECTION. IT WAS REPORTED THAT THE PRESENCE OF ORISE GEL IN TISSUE, WHEN NOT FULLY RESECTED, SOMETIMES PRESENTS A DIAGNOSTIC DILEMMA TO THE CLINICIAN AS WELL AS THE PATHOLOGIST. IT WAS CONFIRMED THAT AN INITIAL POLYPECTOMY WAS ATTEMPTED AFTER INJECTION OF ORISE, HOWEVER IT WAS NOT RESECTABLE. THE INITIAL PROCEDURE DATE WAS (B)(6) 2019.

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 E1, G2: REPORT SOURCE: LITERATURE. THE CITATION IS BELOW. S. WASSIMI, A. CLEMENTS AND M. L. GUERRY-FOCE. CASE REPORT: A DIAGNOSTIC DILEMMA CAUSED BY THE PRESENCE OF ORISE GEL, WHEN NOT REMOVED WITH INITIAL ENDOSCOPIC EN-BLOC RESECTION [MEETING ABSTRACT]. FASEB JOURNAL. 2021; 35:SUPPL 1. BLOCK H2: BLOCK E1, BLOCK B3 AND BLOCK B5 WERE UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON OCTOBER 31, 2022. BLOCK H6: IMPACT CODE F19 CAPTURES THE REPORTABLE EVENT OF SURGICAL INTERVENTION.