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

Model Number	M00570530
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's address 1: (b)(6).(b)(4).A wallflex biliary rx covered stent and delivery system were received for analysis.The stent was returned partially deployed.Visual inspection of the returned device found the stent cover was damaged.Functional examination was performed by actuating the delivery system, and the stent was deployed with no resistance.However, the retrieval loop was found loaded at the distal section of the stent.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.The investigation concluded that the reported event and the observed failures were likely due to procedural factors.It may be that handling and manipulation of the device during attempted deployment, limited the performance of the device and contributed to stent partial deployment and stent cover damaged.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A trial was conducted to recreate the observed failure of the retrieval loop loaded at the distal section of the stent.The defect could not be recreated in process; when the stent was loaded in the incorrect orientation on the delivery system, the stent orientation machine would not cycle and an error message appeared on the screen.The operator could not complete the stent loading task.All units in the batch were conforming when they were released from the manufacturing site.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted to treat a malignant choledochal stenosis after liver transplant in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.Reportedly, the patient stenosis was severe and the anatomy was not dilated prior to stent placement.During the procedure, the stent could not be completely deployed.The stent was removed from the patient partially deployed on the delivery system.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.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the stent cover was damaged.

• 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: 12519032
• Report Number: 3005099803-2021-04945
• Device Sequence Number: 4460061
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/23/2021

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 Expiration Date: 11/18/2022
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0026382139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 65