MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570380
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's exact age was not reported, however, the patient was reported to be over the age of 18.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on august 04, 2020 that a wallflex biliary rx fully covered rmv stent was implanted in the common bile duct during a stent placement procedure performed sometime in february or early march.According to the complainant, on (b)(6) 2020, during a scheduled stent removal procedure, it was noted that the stent slightly migrated, the stent was deformed, and the middle of the stent was kinked.There was difficulty in removing the stent.A foreign body hood protector was used to help remove the stent without damage to the patient or scope.The physician attempted to straighten the stent using a hurricane balloon via dilation and the stent was able to be removed with raptor forceps.Reportedly, the stricture was resolved at the time of the migration.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Photographs provided by the complainant of the device after removal show the stent struts at the proximal end of the stent bent and stretched.The stent was kinked in the middle of the stent.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10457043
• Report Number: 3005099803-2020-03538
• Device Sequence Number: 17025331
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: 08714729953197
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00570380
• Device Catalogue Number: 7038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1