MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965430600
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the stent remained 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 or Problem Description
It was reported to boston scientific corporation on january 28, 2021 that a wallstent biliary uncovered stent was implanted to treat a large periampullary carcinoma in the ampulla during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.According to the complainant, a routine follow up was performed on (b)(6) 2020.During the oesophago-gastro deuodenoscopy (ogd) procedure, it was noted that the stent migrated proximally into the common bile duct.Reportedly, the stent remains implanted and the physician is comfortable leaving the stent in place.However, a different device was implanted to complete the procedure.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.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11340251
• Report Number: 3005099803-2021-00580
• Device Sequence Number: 19676059
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/17/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0025654935
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention