MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX SOFT ENTERAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE

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

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Exact date unknown, event occurred between (b)(6) 2015 to (b)(6) 2021.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Literature source: roy l.J.V.W., giuseppe v., michiel b., et al.Endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for malignant gastric outlet obstruction: an international, multicenter, propensity score-matched comparison.Endoscopy; 2022; 54: 1023-1031.(b)(4).

Event Description

Boston scientific corporation became aware of the following event from referenced literature article endoscopic ultrasound-guided gastroenterostomy versus duodenal stenting for malignant gastric outlet obstruction: an international, multicenter, propensity score-matched comparison." according to the literature, a wallflex duodenal stent was implanted to treat a gastric outlet obstruction (goo) during a duodenal stenting procedure performed on an unknown date.It was reported that the patient experienced cholangitis, bleeding and post procedural pain.

• Brand Name: WALLFLEX SOFT ENTERAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16126973
• MDR Text Key: 306981468
• Report Number: 3005099803-2022-07944
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention