ESOFLIP

Additional Manufacturer Narrative

UF/IMPORTER RPT NUM: (B)(4). MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ACCORDING TO THE REPORTER, A 63-YEAR OLD HAS HAD DYSPHAGIA. SHE HAD PREVIOUS ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION. THE PATIENT WAS INFORMED OF THE HIGHER RISK, INCLUDING PERFORATION FOR THIS PROCEDURE. THE PROCEDURE WAS PERFORMED WITH 30MM DILATING BALLOON UNDER ENDOSCOPIC GUIDANCE. THE MAXIMUM DILATION DIAMETER OF THE FUNDOPLICATION REACHED 27MM. UPON DEFLATING THE BALLOON, THERE WAS A LARGE MUCOSAL TEAR OF THE MUCOSA IN THE DISTAL ESOPHAGUS. THE PATIENT REQUIRED ADMISSION FOR 12 DAYS AND AN ESOPHAGEAL STENT REPLACEMENT.

Additional Manufacturer Narrative

CORRECTED (H11): PLEASE NOTE THAT THE H11 NARRATIVE SUBMITTED PREVIOUSLY CONTAINED AN INVALID USER FACILITY REFERENCE # ((B)(4)). IT WAS DETERMINED THAT THIS REFERENCE WAS IMPROPERLY CONSTRUCTED BY THE USER FACILITY AND USED ERRONEOUSLY ON A VOLUNTARY 3500 FORM SENT TO THE MANUFACTURER. PLEASE DISREGARD THIS NUMBER AS A VALID CROSS-REFERENCE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

ACCORDING TO THE REPORTER, A 63-YEAR-OLD HAS HAD DYSPHAGIA. SHE HAD PREVIOUS ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH DILATION. THE PATIENT WAS INFORMED OF THE HIGHER RISK, INCLUDING PERFORATION FOR THIS PROCEDURE. THE PROCEDURE WAS PERFORMED WITH 30MM DILATING BALLOON UNDER ENDOSCOPIC GUIDANCE. THE MAXIMUM DILATION DIAMETER OF THE FUNDOPLICATION REACHED 27MM. UPON DEFLATING THE BALLOON, WHEN BALLOON WAS REMOVED THERE WAS A LARGE MUCOSAL TEAR OF THE MUCOSA IN THE DISTAL ESOPHAGUS. THE PATIENT REQUIRED ADMISSION FOR 12 DAYS AND AN ESOPHAGEAL STENT REPLACEMENT. ON (B)(6) 2024, AN ESOPHAGOGASTRODUODENOSCOPY WITH FLUOROSCOPY WITH STENT PLACEMENT WAS PERFORMED. THE STENT PLACED WAS A WALLFLEX STENT 18 MM X103. ON (B)(6) 2024, ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED DUE TO THE STENT HAD MIGRATED ABOUT 2 CM. STENT WAS PULLED BACK. AND ON (B)(6) 2024 ESOPHAGOGASTRODUODENOSCOPY WAS PERFORMED TO REMOVE STENT.