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

Model Number M00565010

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

Patient Problems Death (1802); Perforation (2001)

Event Date 10/26/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).The complainant indicated that the device has been disposed 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.

Event Description

It was reported to boston scientific corporation that a wallflex duodenal stent was implanted to treat a 4cm malignant stricture in the duodenum during a stent placement procedure performed on (b)(6) 2015.Reportedly, the patient's anatomy was tortuous.The physician stated that the patient was not a good surgical candidate due to their condition and therefore they elected to do the stent placement procedure.According to the complainant, during the procedure, the physician confirmed the stricture from the duodenal bulb to the superior duodenal angle with an endoscope and inserted a guidewire.The physician then exchanged the scope to a jf-260v and inserted the wallflex duodenal stent delivery system via the guidewire.It was not possible to advance the delivery system at the proximal site of the stricture as the endoscope had waved in the stomach.The physician did not feel that he would be able to deploy the stent and so he removed the endoscope, guidewire, and wallflex duodenal stent and delivery system.He then inserted a large intestine endoscope and manipulated the guidewire toward the stricture.It was noted that the guidewire would not advance in the proper direction.The physician suspected a perforation and stopped the procedure.The physician confirmed a 1cm perforation at the posterior wall of the lesser curvature of the stomach by way of x-ray and ct imaging.An urgent surgical procedure was performed to repair the perforation and it was noted that the patient was in poor nutritional condition at this time.Therefore, the patient developed hypoalbuminemia and then hypouresis.It was reported that the patient died due to acute renal failure on (b)(6) 2015.It is unknown if the patient was treated for the acute renal failure prior to their death.In the physician's assessment, the wallflex duodenal stent delivery system may have contributed to the perforation.In the physician's assessment, there was a relationship between the operation to repair the perforation and acute renal failure.The physician stated that he feels there is a relationship between the patient's death and the procedure performed to repair the perforation.The patient was not undergoing any cancer treatment therapies and no other comorbidities were reported.

• Brand Name: WALLFLEX ¿ DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5245456
• MDR Text Key: 31973796
• Report Number: 3005099803-2015-03404
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/27/2015

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 Expiration Date: 07/08/2017
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0018177912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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; Required Intervention
• Patient Age: 96 YR