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

Device Problems Material Deformation (2976); Activation Failure (3270); Migration (4003); Device Stenosis (4066)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pneumonia (2011); Vomiting (2144); Obstruction/Occlusion (2422); Bowel Perforation (2668); Constipation (3274); Fecal Incontinence (4571); Insufficient Information (4580)

Event Date 08/05/2023

Event Type  Injury  

Manufacturer Narrative

The exact date of event was not reported.The article published date is used for the estimated date of event.The literature article did not provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Literature source: ishibashi, r.; sasaki, t.; isayama, h.; matsuzawa, t.; kuwai, t.; yamada, t.; saito, s.; tomita, m.; shiratori, t.; ikeda, s.; et al."a japanese prospective, multicenter study of colonic stenting for palliation using a high axial force self-expandable metal stent for malignant large bowel obstruction in 200 patients".J.Clin.Med.2023, 12, 5134.Https://doi.Org/10.3390/jcm12155134.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 device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a0406 captures the reportable event of stent kinked.Imdrf patient code e0506 captures the reportable patient complication of hemorrhage, major.Imdrf patient code e2328 captures the reportable patient complication of proximal gastrointestinal obstruction.Imdrf patient code e1006 captures the reportable patient complication of bowel perforation.Imdrf impact code f2305 captures the additional intervention of chemotherapy.Imdrf impact code f19 captures the surgical procedures.Imdrf impact code f23 captures the additional intervention of ablation with argon plasma coagulation (apc).Imdrf impact code f2301 captures the additional stents implanted.

Event Description

Boston scientific corporation became aware of the following event through the article, "a japanese prospective, multicenter study of colonic stenting for palliation using a high axial force self-expandable metal stent for malignant large bowel obstruction in 200 patients" by dr.(b)(6).Per the literature, a multicenter study was conducted to evaluate short- and long-term efficacy and safety of colorectal stenting using an uncovered wallflex enteral colonic stent.Patients with malignant large bowel obstruction were included in this study.Large bowel obstruction was diagnosed using abdominal radiography, colonoscopy, or computed tomography.Patients with a history of colonic stenting were excluded.Other exclusion criteria included enteral ischemia, suspected or impending perforation, intra-abdominal abscess, severe inflammatory changes around the obstruction, and contraindication to endoscopic treatment.Each patient was registered before or immediately after self-expanding metal stent (sems) placement.All clinical data were collected prospectively.Patients who were scheduled for surgical resection were classified as bts, and patients who were not scheduled for surgical resection were classified as pal.A total of 517 patients were enrolled in this study from (b)(6) 2012 to (b)(6) 2013.After excluding ineligible and bts cases, 200 patients were included in the pal cohort.The median age was 74.5 years, and 55.5% of the patients were male.The most common etiology was colorectal cancer (72.5%), followed by gastric (15.5%) and pancreatic cancer (5.5%).Most patients (97.5%) had symptoms of obstruction.Four cases exhibited two obstruction sites.Therefore, 204 obstruction sites were managed using colorectal stenting.Extracolonic obstruction accounted for 31.5% of the obstructions.There were 54 (27.0%) patients with stenosis with peritoneal dissemination.Median obstruction length was 4.0 cm.Most obstructions were located on the left side of the colon (69.6%), with sigmoid colon stenting being the most common.According to the literature, the technical and clinical success rates were 98.5% and 94.5%, respectively for short-term outcomes.Technical failures resulted from failure of guidewire cannulation (n = 2) and perforation by a catheter (n = 1).Among the patients with technical success, clinical failure occurred in only eight cases, due to insufficient stent expansion (n = 3), stent kinking (n = 1), stent migration (n = 1), perforation by stent injury (n = 1), perforation due to delayed decompression (n = 1), and proximal small bowel obstruction (n = 1).Early-onset (less than 7 days) complications occurred in 28 (14.0%) patients.There were four (2.0%) cases of perforation, of which one case was perforated during the procedure and did not achieve technical success, two cases were perforated within 24 hour and did not achieve clinical success, and the remaining case was perforated by stent-edge injury 4 days after stent placement.Of these, two patients underwent surgery: one underwent primary resection and colostomy, the other underwent stoma construction, and both recovered after surgery.Perforations were caused by the catheter during procedure (n = 1), stent-edge injury (n = 2), and delayed decompression (n = 1).There were two cases of perforation involving the stent and its surroundings.Stent migration occurred in one case, and the stent was discharged from the anus.Tenesmus occurred in 3 patients; ileus associated with poor peristalsis occurred in 1 patient.Other minor complications, such as bleeding (n = 4), infection or fever (n = 8), and abdominal pain (n = 9), improved upon conservative treatment.For long-term outcomes, late-onset (greater than 7 days) complications occurred in 66 (33.0%) patients.There were 10 (5.0%) cases of perforation.Only two patients underwent surgery, and the other patients were considered to have a poor prognosis and were treated conservatively.Although most perforations were thought to be related to the stent and its surroundings (n = 5), there were cases with unclear causes (n = 4) or perforation of the tumor at another site (n = 1).Stent obstruction occurred in 24 (12.0%) patients, of which four were treated surgically, nine underwent additional stenting, six underwent stent cleaning, one underwent ablation with argon plasma coagulation (apc), and four received conservative treatment.Regarding the surgical procedures, all four patients underwent colostomy and were found to be alive for more than two months.Proximal gastrointestinal obstruction was observed in 12 (6%) patients.Fifty-six (28.0%) patients underwent chemotherapy after stent placement.Stent migration was observed in 5 (13.2%) of the 38 chemotherapy cases, 2 of which received molecular targeted drugs (panitumumab and bevacizumab).Perforation was observed in two (3.6%) patients, both with colon cancer.One received 5-fluorouracil plus folinic acid plus irinotecan (folfiri) with bevacizumab until just before perforation, which occurred 145 days after stent placement.Other late onset complications also include vomiting without obstructions and interstitial pneumonitis.

• 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: 18607429
• MDR Text Key: 334141484
• Report Number: 3005099803-2024-00219
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/30/2024

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): Required Intervention