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

Device Problems Migration (4003); Device Stenosis (4066)

Patient Problems Abdominal Pain (1685); Bowel Perforation (2668)

Event Date 12/23/2022

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the following event through the article, "outcomes of palliative colonic stent placement in malignant colonic obstruction: experience from a tertiary care oncology center in india", by patil, p., et al.The study aims to analyze the outcomes of patients who underwent colonic self-expanding metal stent (sems) placement for palliation at a tertiary care oncology center in western india.A retrospective review of the endoscopy database was done for patients who underwent colonic sems placement between january 2013 and september 2021.Demographic details, including age, sex, and comorbidities, with an american society of anesthesiologists (asa) grade were recorded.Disease characteristics like primary malignancy, degree of obstruction, site of obstruction, stage of disease, imaging details, and presence or absence of peritoneal disease were also recorded.According to the article, sixty-one patients underwent colonic sems placement for malignant large bowel obstruction during the study period.The mean age of patients was 53.61 + 13.96 years (range 19-85 years), with 50.8% (31/61) patients being male.On pre-procedure assessment, 52.4% (32/61) were asa i, 31.1% (19/61) were asa ii, 14.7% (9/61) were asa iii, and 2 patients were asa iv.Subacute intestinal obstruction (saio) was the presenting complaint in 45 (73.7%) patients, while 15 (24.6%) patients had acute obstruction and 1 (1.6%) patient had a gastrocolic fistula with partially obstructing colonic growth.All 61 patients had clinical and radiological evidence of obstruction.Primary colonic malignancy causing obstruction was seen in 43 (70.5%) patients, whereas extracolonic malignancy was seen in 18 (29.5%) patients.Among the 18 patients with extracolonic malignancy causing bowel obstruction, gallbladder cancer was the most common cause, seen in 8 (43%) patients.The most common site of obstruction was in the sigmoid colon in 18 (29.5%) patients and the descending colon in 12 (19.7%) patients.Proximal colonic obstruction (right and transverse) was seen in 17 (27.9%) patients.Peritoneal metastases were present in 26 (42.6%) patients.The intent of stenting was palliative in all patients.The procedure was performed under conscious sedation and monitored with anesthesia care.The median length of the stricture delineated on fluoroscopy during the procedure was 5 cm (range 2-9 cm).An uncovered colonic wallflex stent was used in 59 (98.3%) patients, and a partially covered sems (non-boston scientific device) was used in a single patient with a gastrocolic fistula.Per the article, two (3.4%) patients had colonic perforation post-stent placement.The first patient, who presented with pain in the left iliac fossa on day 3 of stenting and was diagnosed as having perforation at the proximal end, underwent exploratory laparotomy with hartmann's procedure.The second patient had abdominal pain 25 days after stent placement, with a ct scan showing extravasation of contrast at the mid-stent level.The patient underwent exploratory laparotomy with a diversion stoma.Stent migration was seen in 3 (5.9%) patients.All three underwent surgical retrieval of sems, with surgery for the colonic obstruction as well.The median follow-up period was 9 months (0-21 months).Colonic stent block with recurrent features of obstruction was noted in 13.7% (7/51) patients.Stent block developed after a median period of 6 months.While six cases of stent block were seen in left-sided stent placements, one was seen in proximal colonic obstruction.Of these patients, three underwent sems placement within the sems, and four underwent transverse colostomies.Mortality within 3 months after stent placement was seen in 7 (11.4%) patients; however, there were no deaths related to recurrent bowel obstruction or complications of stent placement.

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: sundaram, s., et al."outcomes of palliative colonic stent placement in malignant colonic obstruction: experience from a tertiary care oncology center in india" journal of digestive endoscopy 2023;14:8-13; doi 10.1055/s-0042-1749073.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a0106 captures the reportable event of stent obstruction within device.Imdrf patient code e1006 captures the reportable patient complication of bowel perforation.Imdrf patient code e1002 captures the reportable patient complication of abdominal pain.Imdrf impact code f19 captures the surgical procedure.Imdrf impact code f2202 captures the additional endoscopic procedure.Imdrf impact code f2301 captures the additional device required to complete the procedure.Imdrf impact code f2203 captures the additional imaging procedure.

• 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: 18599132
• MDR Text Key: 334031090
• Report Number: 3005099803-2024-00132
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• 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): Required Intervention