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

Model Number M00565030

Device Problem Activation Failure (3270)

Patient Problems Death (1802); Perforation (2001); Peritonitis (2252)

Event Date 02/03/2014

Event Type  Death  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the descending part of the duodenum during a stent deployment procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a 2cm malignant stricture due to stage 4 pancreatic head cancer.Reportedly, before the procedure, the progression of cancer was very fast.The patient had chemotherapy before and after the procedure, but the physician reported no good effect of the chemotherapy.The stent was implanted as palliative care.During the procedure, the proximal end of stent was implanted in the stomach by 2cm and the distal end was in the inferior flexure of the duodenum by 2cm.After deployment, it was noted that the stent did not fully expand.On (b)(6) 2014, an abdominal plain film was done and confirmed that the stent was expanding.It was noted that the stent became shortened due to the expansion and the distal end of it was near the inferior flexure of duodenum.Approximately around 10 a.M on (b)(6) 2014, the patient complained of stomach pain.An abdominal plain film was performed and the physician noted free air near the proximal tumor site confirming a perforation.According to the physician, the stent caused the perforation during the slow expansion of the stent.Furthermore, it was reported that the patient had developed peritonitis as a complication of the perforation.No treatment was given to the patient for the perforation or peritonitis because of the patient¿s poor prognosis.In the physician¿s assessment, the patient¿s condition got worse after stenting procedure.On (b)(6) 2014, sedation therapy was given to the patient and the patient was conscious but groggy.On (b)(6) 2014, it was reported that the patient died.In the physician¿s assessment, the cause of death was peritonitis due to the perforation.

Manufacturer Narrative

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 reported event of stent failure to expand.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: 3644050
• MDR Text Key: 16451464
• Report Number: 3005099803-2014-01213
• 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: 02/04/2014

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 Model Number: M00565030
• Device Catalogue Number: 6503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 02/25/2014
• 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: 60 YR