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

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

Patient Problem Injury (2348)

Event Date 06/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated to be (b)(6) 2019 as no specific event date was reported.The complainant was unable to report the suspect device upn and lot number; therefore, the manufacture and expiration dates are unknown.However, it was reported the device was not used past its expiry date.(b)(4).The reported event of "circumstance of the patient".According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplement mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex esophageal stent had been implanted to treat a malignant stricture in the esophagus during a procedure performed on an unknown date.According to the complainant, on an unknown date, the physician tried to remove the stent from the patient due to a circumstance with a patient which was not disclosed by the physician.During the stent removal procedure, the stent retention suture broke when the physician attempted to remove the stent with rat tooth forceps.Reportedly, an overtube was placed, and the stent was successfully removed.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8748751
• MDR Text Key: 149656626
• Report Number: 3005099803-2019-03232
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2019

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: 06/10/2019
• Initial Date FDA Received: 07/01/2019
• 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): Required Intervention