MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM); HEMOSTATIC METAL CLIP FOR THE GI TRACT

Model Number	XTACK-160-H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: impact code f2303 captures the reportable event of medication required.Impact code f2202 captures the reportable event of additional endoscopic procedure.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.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system was used in the esophagus on (b)(6) ,2022 during a stent fixation procedure for esophageal stricture.After the initial procedure, the patient experienced epigastric pain requiring medication.On june 1, 2022 it was determined that the stent migrated.A follow up endoscopy procedure was performed on (b)(6), 2022.The patient was discharged to home with no restrictions.Note: there is no allegation against the x-tack endoscopic helix tacking system and to note the stent was not manufactured by boston scientific.

• Brand Name: X-TACK ENDOSCOPIC HELIX TACKING SYSTEM (160CM)
• Common Device Name: HEMOSTATIC METAL CLIP FOR THE GI TRACT
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s capital of texas hwy; bldg 1 suite 300; austin TX 78746
• Manufacturer (Section G): APOLLO ENDOSURGERY COSTA RICA S.R.L; alajuela, 02 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18275295
• Report Number: 3005099803-2023-06546
• Device Sequence Number: 3226146
• Product Code: PKL
• UDI-Device Identifier: 20811955020760
• UDI-Public: 20811955020760
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201808
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: XTACK-160-H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic