MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BONASTENT ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Device Problems Break (1069); Difficult to Remove (1528); Migration (4003)

Patient Problems Abdominal Pain (1685); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

The upn and lot number is not known per the complainant; therefore, model# has been left blank and the device manufacture and expiration dates cannot be determined.(b)(4).The complainant indicated that the device has been disposed of 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a bonastent was implanted in the gastroesophageal junction to treat an esophageal adenocarcinoma during a procedure performed on (b)(6) 2017.According to the complainant, approximately 4-6 months later, the patient presented to the hospital with abdominal pain.It was then noted that the stent had migrated into the sigmoid colon, "dissolved apart" and caused an occlusion of the large colon.The patient underwent a colonoscopy on (b)(6) 2018, during which an attempt was made to remove the stent using clips.Reportedly, the stent wire was stuck in the mucosa and the stent broke apart into multiple pieces during the removal attempt.The stent removal string also broke off during the removal attempt.The middle section of the stent, which was the section occluding the colon, was able to be removed.The distal end of the stent, which was still patent, was unable to be retrieved and was left implanted.Colorectal surgery got involved, but no surgical intervention was conducted as the patient's prognosis was very poor due to their cancer.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: BONASTENT ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752 1242
• Manufacturer (Section G): STANDARD SCI TECH INCORPORATED; 7 yongdu dong - dongdaemun gu; suite 202 236,130-070; seoul ; KS
• Manufacturer Contact: carole morley ; 100 boston scientific way; ,; marlborough, MA 01752-1242 ; 5086834015
• MDR Report Key: 7882704
• MDR Text Key: 120467992
• Report Number: 3005099803-2018-60484
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/17/2018

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: 08/20/2018
• Initial Date FDA Received: 09/17/2018
• 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