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 Problems Abdominal Pain (1685); Fistula (1862); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Sepsis (2067); Vomiting (2144); No Code Available (3191)

Event Date 09/08/2019

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the suspect device upn and lot number; therefore, the manufacture and expiration dates are unknown.(b)(6).(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on december 23, 2019 that two overlapping wallflex colonic stents were implanted in the sigmoid colon and rectum during a colonoscopic stent placement procedure performed on (b)(6) 2019.The patient was admitted to the hospital on (b)(6) 2019.On (b)(6) 2019, a colonoscopy procedure was performed and found polypoid lesions with edema at 7cm from anal verge causing obstruction to passage of colonoscope.Abdominal x-ray was taken and showed midline surgical staples.On (b)(6) 2019, during colonoscopic stent placement, a guidewire was placed into the descending colon and two overlapping wallflex colonic stent size 12cm and 9cm were placed into the sigmoid colon and rectum.Reportedly, the patient was managed with i/v fluids, i/v antibiotics, i/v proton pump inhibitors (ppi) and supportive measures.An x-ray was performed post stent placement and showed both stents in situ.The patient was discharged on (b)(6) 2019.On (b)(6) 2019, the patient was admitted with complaints of fecal discharges from vagina, a recto-vaginal fistula, with pain in abdomen associated with vomiting for 1 day.Vital signs were taken with the following results: pulse rate of 80/min, respiratory rate of 20/min and blood pressure of 100/60 mmhg.Gastroenterology consultation was taken for pain in abdomen.Gynecology consultation was taken and advise for diversion colostomy.On (b)(6) 2019, the patient was discharged in stable condition with further follow up advice.On (b)(6) 2019, the patient underwent adhesiolysis and diversion ileostomy.On (b)(6) 2019, non-contrast volume scanning through kidneys, ureters and bladder (ncct kub) was performed.Review of the scan noted bilateral ileostomies seen in lower abdomen.A subcentimeter sized open defect was seen in the anterior abdominal wall in infra-umbilical region with an air channel continuous intra-abdominally.Tubular hyperdense stents are seen in rectum and sigmoid colon.There is evidence of air channel continuous with the intra-abdominal free air.Also a suspicious hypodense fluid is seen in pelvis anterior to rectal stent and at the left lateral aspect of sigmoid colon stent measuring 4.2 x 2.7 cm.On (b)(6) 2019, a pet ct scan was performed due to pain at ileostomy site with mucous discharge with vomiting and bleeding per vaginum for past 2-3 days.Reportedly, pet scan was being done for subsequent treatment planning.According to the complainant, the patient has not improved following stent placement but has become weaker.The complainant alleges that the stents are causing infection, bleeding and sepsis and plans to remove the stents.

• 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: 9602255
• MDR Text Key: 176835858
• Report Number: 3005099803-2020-00053
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• 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
• Date Manufacturer Received: 12/23/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 30 YR