MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. ENDOMAXX ESOPHAGEAL STENT

Catalog Number MAXX-2315/C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) of Esophagus (2398)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The medwatch alleges that a patient had a laparoscopic sleeve gastrectomy procedure and developed a gastric stricture.The patient underwent balloon dilatation and when symptoms didn't resolve, the patient then underwent an endoscopic stent placement.Approximately 4 weeks later the patient underwent an elective removal of the esophageal stent.Upon inspection of the covered stent it was noted that the clear covering on the stent was damaged.The physician states that there was approximately a 2cm "rip" in the stent that covered approximately 30-40% of the stent in circumference.An esophagogastroduodenoscopy [edg] was performed and verified the patient suffered an esophageal mucosal injury described by the physician as a "circumferential mucosal degloving" involving the distal esophagus and extending proximately 7cm in length.No perforation or extravasation was noted during a fluoroscopy study utilizing contrast.The patient's mucosa remained attached to the esophagus.The physician was successful in simply folding the mucosa back in place within the esophagus.The patient was admitted to the hospital post-stent removal and was treated with antibiotics and an antifungal medication.Extension in hospitalization was anticipated to be 2-3 days without further complications.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed and no exception documents were found.

• Brand Name: ENDOMAXX ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 14646 kirby drive; houston TX 77047
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 8951603
• MDR Text Key: 156166965
• Report Number: 3010665433-2019-00054
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111611
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: MAXX-2315/C
• Device Lot Number: E1368420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 10/01/2019
• Supplement Dates FDA Received: 10/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2018
• 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): Hospitalization; Required Intervention