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

Model Number	M00570530
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a1: the patient identifier is (b)(6).Block e1: the initial reporter's address is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex biliary rx covered stent was to be implanted in the bile duct to treat a benign.05 cm obstruction of the biliary tract during a metal biliary stent implantation under percutaneous transhepatic biliary drainage procedure performed on (b)(6) 2023.The patient's anatomy was not tight and was not dilated prior to stent placement.During the procedure, the wallflex biliary stent could not be deployed properly.The stent was removed from the patient and the stent's wire was found to be broken.Another wallflex biliary stent was used to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex biliary rx covered stent was to be implanted to treat a benign 0.5 cm tumor.Per the instructions for use (ifu), the device is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery, and it is contraindicated for placement in biliary strictures caused by benign tumors, as the long-term effects of the stent in the bile duct is unknown.The stent is not indicated to treat a benign 0.5 cm tumor.
Additional Manufacturer Narrative
Block a1: the patient identifier is (b)(6).Block b5 has been updated with additional information received on august 22, 2023.Block e1: the initial reporter's address is (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation on june 27, 2023, that a wallflex biliary rx covered stent was to be implanted in the bile duct to treat a benign.05 cm obstruction of the biliary tract during a metal biliary stent implantation under percutaneous transhepatic biliary drainage procedure performed on (b)(6) 2023.The patient's anatomy was not tight and was not dilated prior to stent placement.During the procedure, the wallflex biliary stent could not be deployed properly.The stent was removed from the patient and the stent's wire was found to be broken.Another wallflex biliary stent was used to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex biliary rx covered stent was to be implanted to treat a benign 0.5 cm tumor.Per the instructions for use (ifu), the device is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery, and it is contraindicated for placement in biliary strictures caused by benign tumors, as the long-term effects of the stent in the bile duct is unknown.The stent is not indicated to treat a benign 0.5 cm tumor.Additionally, it was reported that the stent was implanted under percutaneous transhepatic biliary drainage procedure.However, per the instructions for use (ifu), "endoscopic and fluoroscopic placement of the guidewire is recommended.Ensure that the rx locking device (supplied separately) is firmly seated on the endoscope against the side of the working channel port as outlined in its directions for use.Place the 0.035 in (0.89 mm) guidewire through the endoscope, into the ampulla and across the biliary stricture.Lock the guidewire in place with the locking device." the stent should be implanted endoscopically and should not be placed percutaneously.Additional information received on august 22, 2023: it was reported that the wallflex biliary stent was implanted under the guidance of ultrasound, the puncture needle reached the common bile duct through the liver.The guide wire reached the intestine through the common bile duct and duodenal papilla through the puncture needle working channel.The puncture needle was withdrawn, and the guide wire was retained.With the help of the guide wire, the metal stent of the fully coated biliary tract was passed through the common bile duct and duodenal papilla through the liver.
Additional Manufacturer Narrative
Block a1: the patient identifier is (b)(6).Block e1: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h10: the wallflex biliary rx fully covered stent and delivery system were received for analysis.Visual inspection found that the stent was fully covered by the outer sheath and undeployed from the delivery system.A visual and microscopic inspection of the outer sheath found that it was stretched out in the guidewire access sleeve (gas) section.The guidewire access sleeve (gas) ramp was lifted.Microscopic inspection also identified that there was no damage found to the stent.Destructive analysis was also performed to verify the integrity of the stent.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported event of stent failure to deploy; however, the reported event of stent break was not confirmed as the stent was returned fully covered, undeployed, and in good condition.The investigation concluded that the reported events and the additional investigation findings were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied), which could have resulted in the damages noted on the device and prevented the stent from deploying during the procedure.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use (ifu)/product label.It was reported that the stent was to be implanted to treat a benign 0.5 cm tumor during a percutaneous transhepatic biliary drainage.The ifu states, "the device is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery, and it is contraindicated for placement in biliary strictures caused by benign tumors, as the long-term effects of the stent in the bile duct is unknown." additionally, the ifu further states that "the wallflex biliary rx fully covered stent system is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery." therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex biliary rx covered stent was to be implanted in the bile duct to treat a benign.05 cm obstruction of the biliary tract during a metal biliary stent implantation under percutaneous transhepatic biliary drainage procedure performed on (b)(6) 2023.The patient's anatomy was not tight and was not dilated prior to stent placement.During the procedure, the wallflex biliary stent could not be deployed properly.The stent was removed from the patient and the stent's wire was found to be broken.Another wallflex biliary stent was used to complete the procedure.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Note: it was reported that the wallflex biliary rx covered stent was to be implanted to treat a benign 0.5 cm tumor.Per the instructions for use (ifu), the device is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery, and it is contraindicated for placement in biliary strictures caused by benign tumors, as the long-term effects of the stent in the bile duct is unknown.The stent is not indicated to treat a benign 0.5 cm tumor.Additionally, it was reported that the stent was implanted under percutaneous transhepatic biliary drainage procedure.However, per the instructions for use (ifu), "endoscopic and fluoroscopic placement of the guidewire is recommended.Ensure that the rx locking device (supplied separately) is firmly seated on the endoscope against the side of the working channel port as outlined in its directions for use.Place the 0.035 in (0.89 mm) guidewire through the endoscope, into the ampulla and across the biliary stricture.Lock the guidewire in place with the locking device." the stent should be implanted endoscopically and should not be placed percutaneously.Additional information received on august 22, 2023: it was reported that the wallflex biliary stent was implanted under the guidance of ultrasound, the puncture needle reached the common bile duct through the liver.The guide wire reached the intestine through the common bile duct and duodenal papilla through the puncture needle working channel.The puncture needle was withdrawn, and the guide wire was retained.With the help of the guide wire, the metal stent of the fully coated biliary tract was passed through the common bile duct and duodenal papilla through the liver.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17350730
• Report Number: 3005099803-2023-03907
• Device Sequence Number: 5466933
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2023

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: 06/01/2024
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0029515744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 07/31/2023; 10/02/2023
• Initial Report FDA Received Date: 07/19/2023
• Supplement Report FDA Received Date: 08/23/2023; 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 42 KG