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

Model Number M00565030

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Abdominal Pain (1685); Aspiration/Inhalation (1725); Death (1802); Inflammation (1932); Perforation (2001)

Event Date 08/15/2014

Event Type  Death  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the duodenum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a stricture in the descending part of the duodenum due to carcinoma of the pancreas.The patient was also noted to have a stricture in the lower bile duct caused by the malignancy.Reportedly, chemotherapy was performed before and after the procedure.During the procedure, there were no reported issues with the stent placement.Following stent placement the patient was again able to eat.On (b)(6) 2014, a biliary stent was deployed in the lower bile duct by placing it through the side(mesh) of the wallflex duodenal stent.No issues were noted during this procedure.On (b)(6) 2014, the patient complained of stomach pain.A ct scan was performed and the stent was noted to have migrated to the bottom of the pylorus and the ct also showed free air, confirming a perforation in the pylorus of the stomach or duodenal cap.No intervention was performed to address the perforation and the stent was left implanted.During follow up, the patient developed peritonitis and aspiration pneumonitis.The patient died on (b)(6) 2014.According to the physician, the cause of death was peritonitis caused by the perforation, and aspiration pneumonitis.The physician does not believe that there was a malfunction of the device.In the physician¿s assessment, the duodenal stent placement made it possible for the patient to eat; however, peristaltic movement following the stent placement could have led to the stent migration which resulted in the perforation.The physician also noted that tumor growth could distort the shape of the bile duct, and this could also lead to stent migration.According to the physician, the stent caused the perforation, which resulted in the peritonitis and the patient¿s death.

Manufacturer Narrative

Reported event of stent migrated.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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4081956
• MDR Text Key: 4824671
• Report Number: 3005099803-2014-03096
• 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: 08/20/2014

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: 04/17/2016
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 16907582
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2014
• Initial Date FDA Received: 09/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2014
• 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): Death
• Patient Age: 79 YR