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); Device Stenosis (4066)

Patient Problems Erosion (1750); Cardiac Arrest (1762); Fistula (1862); Hemorrhage/Bleeding (1888); Inflammation (1932); Pain (1994); Ulcer (2274); Obstruction/Occlusion (2422); Constipation (3274)

Event Date 01/10/2023

Event Type  Death  

Event Description

Boston scientific corporation became aware of the following event through the article "case report arterial-colonic fistula secondary to colonic stent erosion into the left external iliac artery" by pawloski, k., et al.According to the literature, a 74-year-old woman with a malignant colonic obstruction secondary to a pelvic mass was treated with a 12 cm x 25 mm uncovered wallflex colonic stent.One year later, the patient experienced recurrent pain, obstipation and intermittent, self-limited episodes of hematochezia.Colonoscopy revealed ulcerated mucosa within and just proximal to the stent with luminal narrowing; pathology showed mildly active, nonspecific colitis.The patient elected to undergo surgical intervention to treat her obstruction.Because of extensive adhesions precluding safe dissection, an end colostomy was matured, and the stent was left in place within long a hartmann's stump.Five years later, patient continued to experience intermittent lower gi bleeding requiring transfusion, leading to her current presentation.Flexible sigmoidoscopy demonstrated partial stent erosion into the mucosa with tissue ingrowth and severe friability within the hartmann's stump.The wallflex colonic stent could not be removed endoscopically.The patient desired additional intervention and was taken to the operating room following optimization with a plan to excise the rectal stump and the stent.Upon exploration, an inflamed hartmann's stump was found to be densely adherent to the pelvic sidewall.Arterial hemorrhage was encountered soon after careful attempt to bluntly dissect the stump.Temporary control was achieved with pressure and vascular surgery was consulted.Brisk hemorrhage from the left external iliac artery (eia) was noted upon further mobilization of the stump.The vessel was dissected proximally in an effort to ligate the left eia and perform a femoral-femoral bypass despite resuscitative efforts, the patient went into cardiac arrest and expired after multiple rounds of advanced cardiovascular life support (acls).An autopsy revealed full thickness erosion of the stent with metallic mesh wires embedded throughout the exposed colonic mucosa and transmural erosion of the stent into the left eia with hemorrhage.Note: no further information has been obtained despite good faith efforts.

Manufacturer Narrative

Block b3: the date of event is unknown; however, the literature article published date was used as the event date.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 d6a: although the exact date of the implant is unknown, the wallflex colonic uncovered stent has been in place for 78 months according to published data.Block g2: literature source: pawloski, k., et al."case report arterial-colonic fistula secondary to colonic stent erosion into the left external iliac artery" journal of surgical case reports, 2023, 1, 1-3; doi 10.1093/jscr/rjac615.Block h6: imdrf impact code f02 captures the reportable event of patient's death.Imdrf impact code f2302 captures the reportable event of patient requiring blood transfusion due to extensive lower gi bleeding.Imdrf impact code f19 captures the surgical procedure performed to excise the stent.Imdrf impact code f2202 captures the endoscopic procedure.Imdrf patient code e0602 captures the reportable event of patient went into a cardiac arrest.Imdrf patient code e0506 captures the reportable event of patient experienced lower gi bleeding that required blood transfusion.Imdrf patient code e2006 captures the reportable event of stent erosion into the left external iliac artery.Imdrf device code a0106 captures the reportable device malfunction of stent ingrowth (stent obstruction within device).

Manufacturer Narrative

Block b3: the date of event is unknown; however, the literature article published date was used as the event date.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 d6a: although the exact date of the implant is unknown, the wallflex colonic uncovered stent has been in place for 78 months according to published data.Block g2: literature source: pawloski, k., et al."case report arterial-colonic fistula secondary to colonic stent erosion into the left external iliac artery" journal of surgical case reports, 2023, 1, 1-3; doi 10.1093/jscr/rjac615.Block h6: imdrf impact code f02 captures the reportable event of patient's death.Imdrf impact code f2302 captures the reportable event of patient requiring blood transfusion due to extensive lower gi bleeding.Imdrf impact code f19 captures the surgical procedure performed to excise the stent.Imdrf impact code f2202 captures the endoscopic procedure.Imdrf patient code e0602 captures the reportable event of patient went into a cardiac arrest.Imdrf patient code e0506 captures the reportable event of patient experienced lower gi bleeding that required blood transfusion.Imdrf patient code e2006 captures the reportable event of stent erosion into the left external iliac artery.Imdrf device code a0106 captures the reportable device malfunction of stent ingrowth (stent obstruction within device).Block h11: correction to the initial mdr in blocks b5 and h6 (device codes).

Event Description

Boston scientific corporation became aware of the following event through the article "case report arterial-colonic fistula secondary to colonic stent erosion into the left external iliac artery" by pawloski, k., et al.According to the literature, a 74-year-old woman with a malignant colonic obstruction secondary to a pelvic mass was treated with a self-expanding metal stent and radiotherapy with a stent in-situ time of 78 months, who developed a colonic -arterial fistula to the left external iliac artery.Based on the case report, the patient presented to the emergency department with multiple self-limited episodes of hematochezia.Six years prior to presentation, she had undergone placement of a left colonic wallflex stent for a large bowel obstruction.Two years later, she developed a high-grade large bowel obstruction secondary to a benign stricture at the colorectal anastomosis.A 12 cm x 25 mm uncovered wallflex colonic stent provided temporary relief of her obstructive symptoms.One year later, the patient experienced recurrent pain, obstipation and intermittent, self-limited episodes of hematochezia.Colonoscopy revealed ulcerated mucosa within and just proximal to the stent with luminal narrowing; pathology showed mildly active, nonspecific colitis.The patient elected to undergo surgical intervention to treat her obstruction.Because of extensive adhesions precluding safe dissection, an end colostomy was matured, and the stent was left in place within long a hartmann's stump.Five years later, patient continued to experience intermittent lower gi bleeding requiring transfusion, leading to her current presentation.Flexible sigmoidoscopy demonstrated partial stent erosion into the mucosa with tissue ingrowth and severe friability within the hartmann's stump.The wallflex colonic stent could not be removed endoscopically.The patient desired additional intervention and was taken to the operating room following optimization with a plan to excise the rectal stump and the stent.Upon exploration, an inflamed hartmann's stump was found to be densely adherent to the pelvic sidewall.Arterial hemorrhage was encountered soon after careful attempt to bluntly dissect the stump.Temporary control was achieved with pressure and vascular surgery was consulted.Brisk hemorrhage from the left external iliac artery (eia) was noted upon further mobilization of the stump.The vessel was dissected proximally in an effort to ligate the left eia and perform a femoral-femoral bypass despite resuscitative efforts, the patient went into cardiac arrest and expired after multiple rounds of advanced cardiovascular life support (acls).An autopsy revealed full thickness erosion of the stent with metallic mesh wires embedded throughout the exposed colonic mucosa and transmural erosion of the stent into the left eia with hemorrhage.Note: it was reported that a 12cm x 25mm uncovered wallflex colonic stent was implanted to treat a high-grade large bowel obstruction secondary to a benign stricture at the colorectal anastomosis.However, the wallflex enteral colonic stent with anchor lock delivery system and the wallflex soft enteral colonic stent with anchor lock delivery system are indicated to palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowl obstruction prior to colectomy in patients with malignant strictures.The wallflex colonic stent is not intended to treat large bowel obstructions secondary to a benign stricture.Note: no further information has been obtained despite good faith efforts.

• 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: 18602153
• MDR Text Key: 334023346
• Report Number: 3005099803-2024-00103
• 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: 03/13/2024

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: 02/16/2024
• 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; Other; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female