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

Model Number	H965430500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the stent remains implanted and only the delivery system will be returned for evaluation, however, 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on september 11, 2020 that a wallstent biliary uncovered stent has been implanted to treat a malignant stricture in the common bile duct during a metal stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was deployed successfully.The stent was inspected after placement via endoscopic imaging and the physician noted that the stent wires were broken.Reportedly, the stent remains implanted and the procedure was completed with this device.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.A photo of the device was provided by the complainant of the implanted stent in the patient and it shows that the stent wires were damaged.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) , 2020 that a wallstent biliary uncovered stent has been implanted to treat a malignant stricture in the common bile duct during a metal stenting procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the stent was deployed successfully.The stent was inspected after placement via endoscopic imaging and the physician noted that the stent wires were broken.Reportedly, the stent remains implanted and the procedure was completed with this device.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.A photo of the device was provided by the complainant of the implanted stent in the patient and it shows that the stent wires were damaged.***additional information received on (b)(6) 2020*** according to the complainant, a plastic stent was implanted inside the wallstent biliary uncovered stent to correct the broken stent and the procedure was completed.Reportedly, the patient will be brought in for a follow-up to check whether the stent has caused any damage or ulcer to the duodenum wall.
Additional Manufacturer Narrative
Blocks b1, b2 (outcomes attrib to adv event) b5 and h1 have been updated with the additional information received on (b)(6), 2020.Block h6: problem code 1069 captures the reportable event of damaged stent wires.Block h10: the complainant indicated that the stent remains implanted and only the delivery system will be returned for evaluation; however, 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 medwatch will be filed.
Additional Manufacturer Narrative
Block h6: problem code 1069 captures the reportable event of damaged stent wires.Block h10: a wallstent biliary endoscopic stent delivery system was received for analysis; the stent was not returned.However, a media inspection was performed of photos provided by the complainant and noted that the wires of the stent were damaged inside the anatomy.Visual inspection of the returned delivery system found the outer blue sheath, the inner sheath and the clear sheath were kinked in two different sections.No other issues was noted to the delivery system.During media analysis it was observed the wires of the stent damage inside the anatomy; therefore, the reported event of stent break was confirmed.The investigation concluded that the reported event and observed failures may likely be due to procedural factors.It may be that how the device was manipulated and/or the patient anatomy could have caused the physician to feel resistance contributing to the kinks in the inner and outer sheath.The patient's anatomy may have contributed to the stent break.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to 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 september 11, 2020 that a wallstent biliary uncovered stent has been implanted to treat a malignant stricture in the common bile duct during a metal stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was deployed successfully.The stent was inspected after placement via endoscopic imaging and the physician noted that the stent wires were broken.Reportedly, the stent remains implanted and the procedure was completed with this device.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.A photo of the device was provided by the complainant of the implanted stent in the patient and it shows that the stent wires were damaged.According to the complainant, a plastic stent was implanted inside the wallstent biliary uncovered stent to correct the broken stent and the procedure was completed.Reportedly, the patient will be brought in for a follow-up to check whether the stent has caused any damage or ulcer to the duodenum wall.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10617086
• Report Number: 3005099803-2020-04360
• Device Sequence Number: 16778201
• Product Code: JCT
• UDI-Device Identifier: 08714729204671
• UDI-Public: 08714729204671
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• 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,Followup,Followup
• Report Date (Section B): 12/09/2020

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: 04/17/2021
• Device Model Number: H965430500
• Device Catalogue Number: 3050
• Device Lot Number: 0023664095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 10/09/2020; 11/20/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 10/29/2020; 12/09/2020
• 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