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

Model Number M00565030

Device Problem Partial Blockage (1065)

Patient Problems Dysphagia/ Odynophagia (1815); Vomiting (2144)

Event Date 07/23/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the pylorus during a duodenal stenting procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a gastric outlet obstruction.Reportedly, the patient anatomy was not tortuous.During the procedure, a scope was passed through the patient anatomy and the physician noted gastric residue suggesting a gastric outlet obstruction.A guidewire was passed across the stricture, a cannula was passed over the wire and contrast was injected to determine the length of the stricture.The physician chose a 12cm wallflex enteral duodenal stent to cover the stricture.There were no issues during stent placement and the luminal patency was achieved.On (b)(6) 2014, the patient complained of vomiting and dysphagia.Diagnostic endoscopy was performed and ingrowth of tissue was noted within the stent.The stricture was dilated and another wallflex duodenal stent was implanted within the initially placed stent.Following the placement of the second stent, the patient¿s vomiting and dysphagia abated and the patient is in stable condition.

Manufacturer Narrative

(b)(4) for the reported event of stent blocked.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.

• Brand Name: WALLFLEX ? DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4006632
• MDR Text Key: 17993724
• Report Number: 3005099803-2014-02795
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/23/2014

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: 01/30/2016
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 16701167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2014
• Initial Date FDA Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2014
• 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
• Patient Age: 50 YR