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	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	12/31/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system was used on (b)(6) 2021, for a mucosal defect closure procedure.The procedure was deemed a technical success.The patient was discharged the same day with no restrictions.A follow up endoscopy procedure was performed on (b)(6) 2022, where it is noted that bleeding had reoccurred; they proceeded with a snare polypectomy and used a mantis clip during the procedure.Noted: the x-tack endoscopic helix tacking systeme did not contribute to the bleeding.
Additional Manufacturer Narrative
Block a4: the complainant reported that the patient weights 263.9lb.Block a2: the complainant reported that the patient age was (b)(6).Block h6 impact code of e0506 captures the reportable event of hemorrhage bleeding.
Event or Problem Description
It was reported to boston scientific corporation that an x-tack endoscopic helix tacking system was used on (b)(6) 2021, for a mucosal defect closure procedure.The procedure was deemed a technical success.The patient was discharged the same day with no restrictions.A follow up endoscopy procedure was performed on (b)(6) 2022, where it is noted that bleeding had reoccurred; they proceeded with a snare polypectomy and used a mantis clip during the procedure.Noted: the x-tack endoscopic helix tacking systeme did not contribute to the bleeding.Additional information the follow up endoscopy procedure was performed due to the polyp recurred, the polyp was removed with a snare and the treatment was not impacted by xtack.
Additional Manufacturer Narrative
Block a4: the complainant reported that the patient weights 263.9lb.Block a2: the complainant reported that the patient age was 81.6.Block h6 impact code of e0506 captures the reportable event of hemorrhage bleeding.Block b5 and block b7 have been updated based on additional information received on december.8, 2023.

• 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; alajuela, 02 ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18274588
• Report Number: 3005099803-2023-06555
• Device Sequence Number: 11569409
• 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,Followup
• Report Date (Section B): 01/03/2024

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
• Device Lot Number: AF04548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 12/06/2023
• Supplement Report FDA Received Date: 01/03/2024
• 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: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White