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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 08/05/2023

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: 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 block h6: imdrf patient code e1006 captures the reportable patient complication of bowel perforation.Imdrf impact code f02 captures the reportable event of patient's death.

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.Hiroyuki isayama.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 march 2012 to october 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, early-onset (less than 7 days) complications occurred in 28 (14.0%) patients.There were four (2.0%) cases of perforation.And two of those patients had poor prognoses and were treated conservatively but died.Late-onset (greater than 7 days) complications occurred in 66 (33.0%) patients.Perforation was observed in two (3.6%) patients, both with colon cancer.One of the two patients received 5-fluorouracil plus folinic acid plus oxaliplatin (folfox), and perforation occurred 85 days after stent placement.The patient died nine days after the perforation.

• 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: 18607432
• MDR Text Key: 334105605
• Report Number: 3005099803-2024-00223
• 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

• 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
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/30/2024
• 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): Death