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

Model Number	M00570530
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex biliary rx covered stent was to be implanted in the biliary tract to treat a malignant biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was able to be deployed inside the patient; however, the physician noted a hole on the stent cover.The stent was removed from the patient using forceps and another walflex biliary stent 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.
Additional Manufacturer Narrative
Block h6: medical device problem code a04 captures the reportable event of stent cover damaged.Block h10: a wallflex biliary rx covered stent and delivery system were returned for analysis.The stent was returned completely deployed.Visual examination of the returned device found the stent cover was damaged (ripped) near to the proximal section.No other issues with the stent and delivery system were noted.The reported event of stent cover damaged/defective was confirmed.The investigation concluded that the reported event was likely due to factors encountered during the procedure and/or due to the patient's tight anatomy.It might be that during removal of the delivery system, the stent cover was damaged with the reconstrainment band, limited the performance of the device and contributed to the rip noted in the stent cover.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.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 on march 19, 2021 that a wallflex biliary rx covered stent was to be implanted in the biliary tract to treat a malignant biliary stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on march 17, 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was able to be deployed inside the patient; however, the physician noted a hole on the stent cover.The stent was removed from the patient using forceps and another walflex biliary stent 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: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11655352
• Report Number: 3005099803-2021-01485
• Device Sequence Number: 3610055
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2021

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: 10/30/2022
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0026277774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/20/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 05/10/2021
• 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
• Patient Age: 56 YR
• Patient Weight: 60