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

Model Number	20232
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: patient is 18 years or older.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the bile duct.A 10mmx60mm wallflex biliary transhepatic stent was advanced for treatment.After the stent was placed and the delivery system was removed, resistance was felt on the stent and delivery and the stent jumped.The procedure was completed with a different device.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the bile duct.A 10mmx60mm wallflex biliary transhepatic stent was advanced for treatment.After the stent was placed and the delivery system was removed, resistance was felt on the stent and delivery and the stent jumped.The procedure was completed with a different device.It was further reported that stent migrated from the target location after release.The stent remained implanted and an additional stent was implanted to cover the lesion.No patient complications were noted.
Additional Manufacturer Narrative
A2: age at time of event: patient is 18 years or older.Updated b5: describe event or problem.
Additional Manufacturer Narrative
A2 - age at time of event: patient is 18 years or older.Device evaluated by manufacturer: the stent was not returned for this complaint, only the delivery system was received.The outer clear sheath was inspected and it was found twisted, the twisted section was located approximately at 10cm from the tip.The outer light blue sheath was inspected and it was found kinked, the kinked section was located approximately at 5cm from the luer.No more damages were found in the returned device.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the bile duct.A 10mmx60mm wallflex biliary transhepatic stent was advanced for treatment.After the stent was placed and the delivery system was removed, resistance was felt on the stent and delivery and the stent jumped.The procedure was completed with a different device.It was further reported that stent migrated from the target location after release.The stent remained implanted and an additional stent was implanted to cover the lesion.No patient complications were noted.

• Brand Name: WALLFLEX BILIARY TRANSHEPATIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11020138
• Report Number: 2134265-2020-17776
• Device Sequence Number: 17208487
• Product Code: FGE
• UDI-Device Identifier: 08714729799344
• UDI-Public: 08714729799344
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/19/2021

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: 02/02/2022
• Device Model Number: 20232
• Device Catalogue Number: 20232
• Device Lot Number: 0025147167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 12/26/2020; 01/08/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/06/2021; 01/19/2021
• 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: Other; Required Intervention