MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565650

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

Device code relates to problem code for the reported event of stent positioning problem.Device component code relates to the device problem code for the reported event of stent retrieval loop broke.The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2017 that a wallstent enteral uncovered stent was implanted in the duodenum to treat a 4 cm malignant stricture of the pylorus due to compression by a pancreatic mass during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, the physician was able to successfully deploy the stent in the front portion of the duodenum.However, the stent migrated into the duodenum and away from the stomach.The physician used biopsy forceps and rat tooth forceps to try to reposition the stent but the ends of the stent became undone.The stent migrated further into the duodenum and the physician used forceps to pull the stent back up into the stomach, which caused more stent wires to break.The stent remains implanted and the procedure was completed with this device.It is unknown if the physician plans to remove the broken stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: WALLSTENT¿ ENTERAL ENDOPROSTHESIS
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6963398
• MDR Text Key: 89796175
• Report Number: 3005099803-2017-03083
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729285144
• UDI-Public: 08714729285144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000281
• 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: 09/29/2017

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: 11/04/2018
• Device Model Number: M00565650
• Device Catalogue Number: 6565
• Device Lot Number: 19926034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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