MAUDE Adverse Event Report: APOLLO ENDOSURGERY, INC. OVERSTITCH ENDOSCOPIC SUTURING SYSTEM

Model Number ESS-G02-160

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Internal Organ Perforation (1987); Pain (1994)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

The physician indicated the device will not be returned to apollo for analysis.A review of the device labeling notes the following: warning: only physicians possessing sufficient skill and experience in similar or the same techniques should perform endoscopic procedures.Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing synthetic absorbable sutures for wound closure, as the risk of wound dehiscence may vary with the site of application and the suture material used.Ensure that there is sufficient space for the needle to open.Warning: do not introduce the device with the needle body in its open position.Adverse event: possible complications that may result from using the endoscopic suturing system include, but may not be limited to: abdominal pain and / or bloating.Pharyngeal, colonic and/or esophageal perforation.Esophageal, colonic and/or pharyngeal laceration.Intra-abdominal (hollow or solid) visceral injury.

Event Description

Reported as: a patient who underwent an endoscopic sleeve gastroplasty utilizing the overstitch endoscopic suturing system was noted to have a complication.A patient had a procedure and was doing well however they began to have pain while standing up.The patient went to the er and the trauma surgeon did laparotomy and found a gastric perforation.The physician took down the esg and repaired the defect.Notes from procedure indicate a "full thickness tear from a full thickness suture that pulled through." physician believes it was the reinforcement stitch and it was cinched too tightly.

• Brand Name: OVERSTITCH ENDOSCOPIC SUTURING SYSTEM
• Type of Device: SUTURING SYSTEM
• Manufacturer (Section D): APOLLO ENDOSURGERY, INC.; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin TX 78746
• Manufacturer (Section G): VIANT MEDICAL; 5079 33rd street se; grand rapids MI 49512
• Manufacturer Contact: laura leboeuf ; 1120 s. capital of texas hwy; bldg 1, ste. 300; austin, TX 78746
• MDR Report Key: 8670412
• MDR Text Key: 147051387
• Report Number: 3006722112-2019-00124
• Device Sequence Number: 1
• Product Code: OCW
• UDI-Device Identifier: 10811955020664
• UDI-Public: 10811955020664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081853
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS-G02-160
• Device Catalogue Number: ESS-G02-160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR