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 11/18/2022

Event Type  Death  

Event Description

Boston scientific corporation became aware of the following event through the article " outcome of self expandable metal stents placement for obstructive colorectal cancer: 7 years' experience from a swedish tertiary center", by papachrysos, n., et al.The study aims to review the outcomes of self-expanding metal stent (sems) treatment in a tertiary center and to find predictors for the clinical outcome.The data were analyzed from sems insertion at sahlgrenska university hospital, between 2014 and 2020.Patients were identified through an administrative database that continuously registered all the sems insertions.The inclusion criteria were computed tomography (ct) scan verified acute colonic obstruction or progressive obstructive symptoms in patients already diagnosed with colorectal cancer.The obstruction was located from the right colon to the rectum.The purpose of stenting was either palliation or bridging to surgery.According to the literature, a total of 265 self-expanding metal stents (sems) insertions (mean age 72, female 49.4%) were identified.Most sems were used for palliation (90.2%).The malign obstruction was most often located in the left colon (71.7%).All procedures were performed using wallflex colonic and wallflex soft stents uncovered.Patients were placed under conscious sedation.Stent deployment was performed over the guidewire by the through-the-scope tts technique.Correct positioning was assured by fluoroscopy.According to the article adverse events, eleven patients (4.2%) had a perforation during the first 48 postoperative hours and were immediately evaluated by a colorectal surgeon.Three of the perforations caused the patients' death within few weeks after the sems insertion of whom one in the bridge to surgery group.At the end of the study, the sems related mortality was calculated at 1.1% (3/265), the 30-days mortality rate was 11.7% and the 90-day was 31.7%.Most of the deaths were due to colorectal cancer progress.

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: papachrysos, n., et al."outcome of self-expandable metal stents placement for obstructive colorectal cancer: 7 years' experience from a swedish tertiary center" surgical endoscopy (2023) 37:2653-2658; doi 10.1007/s00464-022-09761-2.Block h6: imdrf impact code f02 captures the reportable event of patient's death.Imdrf patient code e1006 captures the reportable patient complication of bowel perforation.

Event Description

Boston scientific corporation became aware of the following event through the article " outcome of self expandable metal stents placement for obstructive colorectal cancer: 7 years' experience from a swedish tertiary center", by papachrysos, n., et al.The study aims to review the outcomes of self-expanding metal stent (sems) treatment in a tertiary center and to find predictors for the clinical outcome.The data were analyzed from sems insertion at sahlgrenska university hospital, between 2014 and 2020.Patients were identified through an administrative database that continuously registered all the sems insertions.The inclusion criteria were computed tomography (ct) scan verified acute colonic obstruction or progressive obstructive symptoms in patients already diagnosed with colorectal cancer.The obstruction was located from the right colon to the rectum.The purpose of stenting was either palliation or bridging to surgery.According to the literature, a total of 265 self-expanding metal stents (sems) insertions (mean age 72, female 49.4%) were identified.Most sems were used for palliation (90.2%).The malign obstruction was most often located in the left colon (71.7%).All procedures were performed using wallflex colonic and wallflex soft stents uncovered.Patients were placed under conscious sedation.Stent deployment was performed over the guidewire by the through-the-scope tts technique.Correct positioning was assured by fluoroscopy.According to the article adverse events, eleven patients (4.2%) had a perforation during the first 48 postoperative hours and were immediately evaluated by a colorectal surgeon.Three of the perforations caused the patients' death within few weeks after the sems insertion of whom one in the bridge to surgery group.At the end of the study, the sems related mortality was calculated at 1.1% (3/265), the 30-days mortality rate was 11.7% and the 90-day was 31.7%.Most of the deaths were due to colorectal cancer progress.Additional information received on february 1, 2024: according to the physician, the perforation was located in the middle of the stent body where the tumor was located.The patient's bowel perforation was confirmed via ct scan and an emergency surgery was performed to treat the perforation.

Manufacturer Narrative

Block b3: the exact date of event was not reported.The article published date is used for the estimated date of event.Blocks b5 and h6 (impact codes) have been updated based on the additional information received on february 1, 2024.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: papachrysos, n., et al."outcome of self-expandable metal stents placement for obstructive colorectal cancer: 7 years' experience from a swedish tertiary center" surgical endoscopy (2023) 37:2653-2658; doi 10.1007/s00464-022-09761-2 block h6: imdrf impact code f02 captures the reportable event of patient's death.Imdrf impact code f19 captures the emergency surgery to resolve patient's bowel perforation.Imdrf patient code e1006 captures the reportable patient complication of bowel 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: 18580686
• MDR Text Key: 333737453
• Report Number: 3005099803-2024-00123
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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,Followup
• Report Date: 02/23/2024

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?: No
• 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: 01/25/2024
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/23/2024
• 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