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

Model Number M00565020

Device Problems Partial Blockage (1065); Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the duodenum during a stent placement for duodenum procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a 3cm stricture from the pylorus to duodenal bulb due to malignancy.Reportedly, the patient's anatomy was tortuous.During the procedure, the stent was implanted without issue.The patient was stable and able to have meals.The physician checked the stent on (b)(6) 2014 and confirmed the stent location was fine.The anticancer drug ts1 was prescribed to the patient on (b)(6) 2014.On (b)(6) 2014, the patient complained of loss of appetite and a computed tomography was performed.The physician confirmed that the stent had migration to the jejunum.The stent was left in place at this time because the physician was concerned about the patient¿s poor nutrition and possible complications from the surgery.The physician planned to perform surgery to remove the stent when the stent has migrated closer to the anus and the patient¿s nutrient state is improved.The patient was hospitalized after the stent migration was noted.In the physician¿s assessment peristalsis could have led to the stent migration.On (b)(6) 2014, computed tomography showed that the stent had moved to the anus side of the ileum and there were no complications to the patient.The physician opted to do follow-up without surgery because the patient¿s nutrition still had not improved due to stopping eating and accumulation of ascitic fluid due to decreased plasma albumin.On (b)(6) 2014, stent removal procedure was attempted colonoscopically.The stent was located 5 cm on the anus side of the ileum, only one loop of the stent was visible and the other loops were hidden in a fold.The flare at the distal end of the stent was slightly buried in the epidermis.At this time the physician gave up removing the stent from the patient based on the stent condition, and the procedure was aborted and the stent remained implanted.The physician planned continue to do follow-up without surgery as the patient still has poor nutrition.

Manufacturer Narrative

(b)(4).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.

Manufacturer Narrative

Investigation results: a visual and functional examination of the complaint device could not be performed since the device was not returned for analysis.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.Stent migration and obstruction are listed within the dfu as a potential adverse events.Therefore, the most probable root cause is anticipated procedural complication.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no other complaints exist for the specified batch.

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the duodenum during a stent placement for duodenum procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a 3cm stricture from the pylorus to duodenal bulb due to malignancy.Reportedly, the patient's anatomy was tortuous.During the procedure, the stent was implanted without issue.The patient was stable and able to have meals.The physician checked the stent on (b)(6) 2014 and confirmed the stent location was fine.The anticancer drug ts1 was prescribed to the patient on (b)(6) 2014.On (b)(6) 2014, the patient complained of loss of appetite and a computed tomography was performed.The physician confirmed that the stent had migration to the jejunum.The stent was left in place at this time because the physician was concerned about the patient¿s poor nutrition and possible complications from the surgery.The physician planned to perform surgery to remove the stent when the stent has migrated closer to the anus and the patient¿s nutrient state is improved.The patient was hospitalized after the stent migration was noted.In the physician¿s assessment peristalsis could have led to the stent migration.On (b)(6) 2014, computed tomography showed that the stent had moved to the anus side of the ileum and there were no complications to the patient.The physician opted to do follow-up without surgery because the patient¿s nutrition still had not improved due to stopping eating and accumulation of ascitic fluid due to decreased plasma albumin.On (b)(6) 2014, stent removal procedure was attempted colonoscopically.The stent was located 5 cm on the anus side of the ileum, only one loop of the stent was visible and the other loops were hidden in a fold.The flare at the distal end of the stent was slightly buried in the epidermis.At this time the physician gave up removing the stent from the patient based on the stent condition, and the procedure was aborted and the stent remained implanted.The physician planned continue to do follow-up without surgery as the patient still has poor nutrition.Additional information received december 6, 2014.In early (b)(6) , endoscopy was performed and found that the original stenosis where the stent was placed was not a severe stenosis.In the physician¿s assessment, the possible cause of stent migration was the mildness of the stenosis.The physician reported that the patient had started eating rice gruel.

• 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: 4247638
• MDR Text Key: 18542243
• Report Number: 3005099803-2014-03614
• 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,Followup
• Report Date: 10/22/2014

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: 06/24/2016
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0017074637
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 11/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2014
• 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): Hospitalization; Required Intervention