MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. STENT ESPH 23MM 24FR 90CM 150 - SMAXX-2315; PROSTHESIS, ESOPHAGEAL

Model Number MAXX - 2315

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Injury (2348)

Event Date 07/10/2019

Event Type  Injury  

Event Description

Pt had laparoscopic sleeve gastrectomy and developed a gastric stricture.Pt underwent balloon dilatation and when symptoms didn't resolve, pt underwent endoscopic stent placement.Approx 4 weeks later, pt had elective removal of stent without difficulty during removal process.Immediately post stent removal, during completion egd, it was visualized that the pt had an esophageal mucosal injury.It was described by md as a "circumferential mucosal degloving type of injury" involving the distal esophagus and extending approx 7 cm in length.No leak or extravasation was noted during fluoroscopy study utilizing dye.Mucosa remained attached to the esophagus and was able to be folded back into place.Upon inspection of the covered stent, it was noted that the clear covering over the metal "teeth" of the stent was not intact and that there was an approx 2cm 'rip' in the stent that went around approx 30%-50% of the stent circumference.Pt was admitted to the hosp postop and treated with antibiotics and antifungals.Expected length of stay is anticipated to be 2-3 days barring further complications.Fda safety report id# (b)(4).

• Brand Name: STENT ESPH 23MM 24FR 90CM 150 - SMAXX-2315
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC. ; jordan UT 84095
• MDR Report Key: 8793345
• MDR Text Key: 151263708
• Report Number: MW5088122
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: MAXX - 2315
• Device Lot Number: E1368420
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR
• Patient Weight: 68