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

Model Number	M00570540
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Liver Damage/Dysfunction (1954); Discomfort (2330)
Date of Event	06/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed 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 june 05, 2020 that a wallflex biliary rx covered stent was implanted in the common bile duct during a biliary stent implantation procedure performed on (b)(6), 2020.According to the complainant, post procedure, the patient experienced discomfort and increased bilirubin which prompted the physician to check the stent placement.On (b)(6), 2020, imaging was performed and confirmed that the stent migrated.The stent naturally passed out of the patient.Reportedly, the stricture had not yet resolved when the stent migrated.In the physician's assessment, the patient's bilirubin was too high to accept a second procedure at this time and the patient will be re-scheduled for a second procedure for stent implantation.The patient received drug therapy treatment for the discomfort and increased bilirubin.In the physician's assessment, the stent migration may have caused the discomfort and the stent migration caused the increased bilirubin.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10206733
• Report Number: 3005099803-2020-02407
• Device Sequence Number: 2273174
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/29/2020

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: 09/02/2021
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0024369723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/05/2020
• Initial Report FDA Received Date: 06/29/2020
• 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
• Patient Age: 85 YR
• Patient Weight: 67