MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570360
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: approximated based on the month and year the stent was implanted.Report source: medwatch# (b)(4).(b)(4).It is unknown if the device will be returned for evaluation; therefore a problem analysis of the complaint device could not be completed.If any further relevant information is identified, 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 fully covered rmv stent was implanted during a procedure performed in (b)(6) 2021.Reportedly, the stent was scheduled to be removed during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During the stent removal procedure, the stent began to unravel and was difficult to remove.Reportedly, the stent was able to be removed except for a broken stent wire that was left in the duct.The patient was then transferred to a different facility for removal of the unretrieved wire.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• 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: 12824139
• Report Number: 3005099803-2021-05898
• Device Sequence Number: 13797352
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: 08714729953173
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/16/2021

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: 08/26/2022
• Device Model Number: M00570360
• Device Catalogue Number: 7036
• Device Lot Number: 0025918669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 35 KG
• Patient Race: White