MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ¿ DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565030

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

Patient Problem Death (1802)

Event Date 05/05/2017

Event Type  Death  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant reported that the device was not expired.The complainant indicated that the device has been disposed of 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was to be implanted in the duodenum to treat gastric outlet obstruction during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.Reportedly, the patient had ampullary cancer and the stent was being placed as a palliative treatment.According to the complainant, during the procedure, the wallflex enteral duodenal stent was successfully implanted without issue.After the physician left the room, the patient was stable for a few minutes; however, the patient then coded and died ten minutes later.The physician reported that there was no relationship between the patient's death and the wallflex enteral duodenal stent.The patient's cause of death remains unknown.

• Brand Name: WALLFLEX ¿ DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 6596311
• MDR Text Key: 76123387
• Report Number: 3005099803-2017-01641
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062750
• 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: 05/05/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2017
• Initial Date FDA Received: 05/28/2017
• 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): Death
• Patient Age: 80