MAUDE Adverse Event Report: WILY RUSCH GMBH POLYFLEX ESOPHAGEAL STENT

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Bowel Perforation (2668)

Event Date 06/18/2014

Event Type  Injury  

Event Description

Dr (b)(6), an endoscopist on staff at (b)(6) medical center, informed the gi staff on (b)(6) 2014 of a hospital admission on a recent gi pt.The pt had an esophageal stent placed on (b)(6) 2014 for dysphagia.The stent migrated to the bowel with an eventual perforation and colon resection on (b)(6) 2014 and further repair on (b)(6) 2014.On (b)(6) 2014 an esophageal stent was placed in the operating room under fluoroscopy at (b)(6) medical center by dr (b)(6), an on staff endoscopist.A boston scientific vendor was present during the procedure to address any mfr questions about the medical device.The pt tolerated the procedure well and was discharged home.On (b)(6) 2014 the pt was instructed by dr (b)(6) following a repeat egd performed at another facility to come to the er.The egd findings noted the stent was not visualized in the esophagus.Dr (b)(6) initiated a surgical consult.Dr (b)(6), an on staff general surgeon, reviewed the ordered x-rays and labs from the er admission and scheduled an exploratory laparotomy the same day.A small bowel resection was performed.Per the dictated operative report, the stent was wedged in the distal ileum adhered to the interior abdominal wall in the right upper quadrant.The specimen was labeled and sent to pathology for examination.The medical device was removed, labeled, and secured.Following this procedure, this (b)(6) pt, was admitted to icu for care.On (b)(6) 2014 the pt returned to the operating room for a re-exploratory laparotomy with repair of a small bowel tear/fistula with placement of a feeding jejunostomy.Following the procedure, he returned to icu for care.The quality and risk mgmt dept was notified in addition to the vp of nursing services.An inservice on medical device reporting was conducted for surgery dept staff on (b)(6) 2014.

• Brand Name: POLYFLEX ESOPHAGEAL STENT
• Type of Device: ESOPHAGEAL STENT
• Manufacturer (Section D): WILY RUSCH GMBH; kernen D-713 94; GM D-71394
• MDR Report Key: 4014006
• MDR Text Key: 4880184
• Report Number: 4014006
• Device Sequence Number: 1
• Product Code: ESW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR