MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570540
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(4) 2017 that a wallflex biliary rx covered stent was implanted to treat a stenosis in the common bile duct during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during an imaging recheck of the stent on (b)(6) 2017, the stent was found to have slightly migrated.On the same date, the migrated stent was removed using forceps and the procedure was completed with another wallflex biliary stent.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.
Additional Manufacturer Narrative
A fully deployed wallflex biliary rx covered stent was received for analysis.The delivery system was not returned.The stent was measured to be within specifications.No issues noted with the stent.The investigation concluded that the reported event was likely due to anatomical or procedural factors which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.A review of the device history record (dhr) and no deviation was found.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex biliary rx covered stent was implanted to treat a stenosis in the common bile duct during a stent placement procedure performed on (b)(6) 2017.According to the complainant, during an imaging recheck of the stent on (b)(6) 2017, the stent was found to have slightly migrated.On the same date, the migrated stent was removed using forceps and the procedure was completed with another wallflex biliary stent.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: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7178355
• Report Number: 3005099803-2017-04006
• Device Sequence Number: 13788748
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2017

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: 07/22/2018
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 19508215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 12/19/2017
• Supplement Date Received by Manufacturer: 01/17/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 02/12/2018
• 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