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 Bowel Perforation (2668)

Event Date 02/05/2015

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6), 2015 that a wallflex enteral duodenal stent had been implanted in the duodenum during a gastroduodenal stenting procedure performed on (b)(6), 2015.According to the complainant, the stent was implanted to treat a malignant stricture between the duodenum bulb to the descending limb of the duodenum due to infiltration of pancreatic cancer.The proximal portion of the stent was positioned in the stomach and the distal portion was positioned near the papilla vater.Reportedly, the patient¿s anatomy was noted to have minor tortuosity.No issues were noted during the stent implantation procedure.Following the procedure, the patient was in good condition and was able to eat.On (b)(6), 2015, the patient had a stomachache.A ct scan was performed and revealed free air in the abdominal cavity confirming a perforation.The perforation was located on the proximal side of the stent around the duodenum bulb.In the physician¿s assessment, the radial expansion force of the stent might have contributed to the perforation.He also thought there was no alternative other than to place the stent to improve the patient¿s quality of life, and perforation couldn¿t be avoided.The patient is being monitored conservatively, the stent remains implanted and the physician does not plan to remove it.

Manufacturer Narrative

(b)(4): the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.Investigation results a visual and functional examination of the complaint device could not be performed since the device was not returned for analysis.From the information available this device was used per the directions for use (dfu) / product label.Perforation is listed in the dfu for this product as a potential post stent placement complication related to the use of this device.Therefore, the most probable root cause is anticipated procedural complication.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4548139
• MDR Text Key: 5528061
• Report Number: 3005099803-2015-00452
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• 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: 02/05/2015

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: 02/05/2015
• Initial Date FDA Received: 02/26/2015
• 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): Other