MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565060

Device Problem Positioning Problem (3009)

Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Date 11/01/2016

Event Type  Injury  

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 on (b)(6) 2016 that a wallflex enteral colonic stent was to be used implanted in the sigmoid colon to treat a malignant stricture due to stage 4 adenocarcinoma of the colon during a colonoscopy with stent placement procedure performed on (b)(6) 2016.Reportedly, the patient¿s cancer has metastasized to the liver and breasts.According to the complainant, during the initial stent placement procedure, the physician inserted a wallstent superstiff guidewire in to the colonic stricture.However, the physician noted that the wrong end of the guidewire was used.The physician removed the wallstent superstiff guidewire and used a 0.035 in jagwire guidewire.The wallflex colonic stent was placed over the guidewire and was implanted successfully.On (b)(6) 2016, the patient presented with a mild abdominal pain.The physician performed a kidneys, ureters, bladder (kub) x-ray and a perforation of the sigmoid colon which was approximately 20cm from the anal verge was noted.Additionally, it was noted that the stent was implanted in an unintended location and was placed in the perforated site.According to the physician, the wallstent superstiff guidewire created a false track and the stiff end of the guidewire caused the perforation.In the physician¿s assessment, the stent was implanted in the perforated site due to the false track created by the guidewire.The physician performed a hartsman surgery and removed the stent together with the tumor and the perforated bowel.There were no other patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Updated with the additional information received on december 28, 2016 from medwatch report mw5066623.

Event Description

It was reported to boston scientific corporation on november 3, 2016 that a wallflex enteral colonic stent was to be used implanted in the sigmoid colon to treat a malignant stricture due to stage 4 adenocarcinoma of the colon during a colonoscopy with stent placement procedure performed on (b)(6) 2016.Reportedly, the patient¿s cancer has metastasized to the liver and breasts.According to the complainant, during the initial stent placement procedure, the physician inserted a wallstent superstiff guidewire in to the colonic stricture.However, the physician noted that the wrong end of the guidewire was used.The physician removed the wallstent superstiff guidewire and used a 0.035 in jagwire guidewire.The wallflex colonic stent was placed over the guidewire and was implanted successfully.On (b)(6) 2016, the patient presented with a mild abdominal pain.The physician performed a kidneys, ureters, bladder (kub) x-ray and a perforation of the sigmoid colon which was approximately 20cm from the anal verge was noted.Additionally, it was noted that the stent was implanted in an unintended location and was placed in the perforated site.According to the physician, the wallstent superstiff guidwire created a false track and the stiff end of the guidewire caused the perforation.In the physician¿s assessment, the stent was implanted in the perforated site due to the false track created by the guidwire.The physician performed a hartsman surgery and removed the stent together with the tumor and the perforated bowel.There were no other patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on december 28, 2016: the indication for stent placement was for a sigmoid colon adenocarcinoma and the procedure was flexible sigmoidoscopy under general anesthesia.During the procedure, the physician noted a 30 cm luminal narrowing stricture, passed a guidewire through the stricture under fluoroscopy, and dilated the stricture with a balloon.The physician noted some difficulty during the procedure with the kinking of the balloon/guidewire.Reportedly, post-procedure, the patient complained of nausea and periumbilical pain.The physician noted that the patient had a firm and distended abdomen.Radiological findings were ¿consistent with a large pneumoperitoneum with associated dilated loops of large and possibly small bowel to the level of a partially collapsed stent is concerning for a large bowel obstruction with bowel perforation¿.The patient was sent to the operating room and underwent an exploratory laparotomy with sigmoid resection of the perforated rectosigmoid mass.Additionally, the stent was noted to have perforated through and through the mass.Reportedly, the patient was discharged.

• Brand Name: WALLFLEX¿ COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 6124921
• MDR Text Key: 60845719
• Report Number: 3005099803-2016-03606
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2016

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: M00565060
• Device Catalogue Number: 6506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• 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): Required Intervention
• Patient Age: 84 YR