MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE

Device Problem Device Stenosis (4066)

Patient Problems Erosion (1750); Diarrhea (1811); Fistula (1862); Nausea (1970); Restenosis (4576); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/19/2014

Event Type  Death  

Manufacturer Narrative

Block b3: the exact date of event was not reported.The article published date is used for the estimated date of event.Block d4, h4: the literature article did not provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source: ross, p., et al." enterocolic fistula due to a rectal stent: case report and literature review".Annals of medicine and surgery 3 (2014) 123-125.Doi: http://dx.Doi.Org/10.1016/j.Amsu.2014.07.002 block h6: imdrf device code a0106 captures the reportable event of stent obstruction within device.Imdrf patient code e2006 captures the reportable event of stent had eroded through the medial wall of the descending colon.Imdrf patient code e1008 captures the reportable event of diarrhea.Imdrf patient code e233701 captures the reportable event of restenosis.Imdrf patient code e1020 captures the reportable event of nausea.Imdrf patient code e2314 captures the reportable event of fistula.Imdrf patient code e2402 captures the reportable event of distention.Imdrf impact code f2202 captures the reportable event of endoscopy showed tumor growing into and around the upper end of the stent.Imdrf impact code f2203 captures the reportable event of abdominal x-ray and ct revealed a high-grade obstruction.Imdrf impact code f19 captures the reportable event of multiple sharp protruding ends were trimmed and the remaining ends were curled back into the lumen with a needle driver.Imdrf impact code f2301 captures the reportable event of the stent was mobilized from the colon wall for 2 cm and was divided circumferentially with a large metal cutter.Imdrf impact code f02 captures the reportable event of the patient died in hospice 22 months after diagnosis of his recurrence.Imdrf impact code f08 captures the reportable event of warranted admission.Imdrf impact code f1901 captures the reportable event of the defect was repaired with lembert sutures and covered with omentum.A loop ileostomy was created.Attempts to reposition the stent across the tract.

Event Description

Boston scientific corporation became aware of the following event through the article, "enterocolic fistula due to a rectal stent: case report and literature review", by ross, p., et al.According to the literature, a case of a 73-year-old, male, with near obstructing sigmoid carcinoma, was successfully implanted with a wallflex colonic stent.However, two months post stent placement, the patient experienced diarrhea, nausea, and abdominal distention that warranted admission.Abdominal x-ray was performed, and results revealed a high-grade obstruction with distention of both small bowel and colon.Endoscopy was performed, and results showed a tumor growing into and around the upper end of the stent.Laparotomy procedure was performed, and it revealed a large pelvic mass bulging upward out of the pelvis.Two loops of small bowel were observed adherent to the pelvis wall.Upon further exploration, the second loop of bowel was found to be adherent to the upper end of the metallic stent.The stent had eroded through the medial wall of the descending colon just superior to the pelvic mass and into the distal ileum, creating an enterocolic fistula.The stent was mobilized from the colon wall for 2 cm and was divided circumferentially with a large metal cutter.Multiple sharp protruding ends were trimmed, and the remaining ends were curled back into the lumen with a needle driver.The colon defect was now well above the remaining stent which was solidly incorporated into the colorectal wall and tumor.The defect was repaired with lembert sutures and covered with omentum, and a loop ileostomy was then created.The patient recovered well.However, the patient died in hospice 22 months after diagnosis of his recurrence.

• Brand Name: WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18610740
• MDR Text Key: 334138876
• Report Number: 3005099803-2024-00131
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• 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): Hospitalization; Death; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male