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

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/16/2023

Event Type  Injury  

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: walayat, s., et al."outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature".World j gastrointest endosc 2023; 15(4): 309-318.Doi: 10.4253/wjge.V15.I4.309.Block h6: imdrf device code a010402 captures the reportable event of stent migration.

Event Description

Boston scientific corporation became aware of the following event through the article, "outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature", by walayat, s., et al.Per the literature, a retrospective reviewed was performed to all patient who underwent colonic self-expanding metal stent placement from (b)(6) 2004 through (b)(6) 2022 at university of wisconsin.There were sixty-three patients over the age of 18 who underwent colonic stent placement.Fifty-five cases were for malignant indication, and eight were for benign conditions.The benign strictures included diverticular disease stricturing (n = 4), fistula closure (n = 2), extrinsic fibroid compression (n = 1), and ischemic stricture (n = 1).Forty-three of the malignant cases were due to intrinsic obstruction from primary or recurrent colon cancer; 12 were from extrinsic compression.Fifty-four strictures occurred on the left side, 3 occurred on the right and the rest in transverse colon.According to the literature, a case of a 55-year-old, female, was successfully implanted with a wallflex colonic stent for fistula closure at the sigmoid colon.However, post stent placement, the stent had migrated.

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: walayat, s., et al."outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature".World j gastrointest endosc 2023; 15(4): 309-318.Doi: 10.4253/wjge.V15.I4.309 block h6: imdrf device code a010402 captures the reportable event of stent migration.Block h11: correction to the initial mdr in blocks b5 and h6 (device code).

Event Description

Boston scientific corporation became aware of the following event through the article, "outcomes of colon self-expandable metal stents for malignant vs benign indications at a tertiary care center and review of literature", by walayat, s., et al.Per the literature, a retrospective reviewed was performed to all patient who underwent colonic self-expanding metal stent placement from august 2004 through august 2022 at university of wisconsin.There were sixty-three patients over the age of 18 who underwent colonic stent placement.Fifty-five cases were for malignant indication, and eight were for benign conditions.The benign strictures included diverticular disease stricturing (n = 4), fistula closure (n = 2), extrinsic fibroid compression (n = 1), and ischemic stricture (n = 1).Forty-three of the malignant cases were due to intrinsic obstruction from primary or recurrent colon cancer; 12 were from extrinsic compression.Fifty-four strictures occurred on the left side, 3 occurred on the right and the rest in transverse colon.According to the literature, a case of a 55-year-old, female, was successfully implanted with a wallflex colonic stent for fistula closure at the sigmoid colon.However, post stent placement, the stent had migrated.Note: it was reported that the wallflex colonic stent was implanted for a benign indication of treating a fistula.However, per the wallflex colonic soft stent system with anchor lock delivery system instructions for use, the stent is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.

• 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: 18603201
• MDR Text Key: 334036409
• Report Number: 3005099803-2024-00190
• 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,Followup
• Report Date: 03/29/2024

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: 03/08/2024
• 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
• Patient Age: 55 YR
• Patient Sex: Female