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

Model Number	M00570730
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/01/2022
Type of Reportable Event	Death
Event or Problem Description
It was reported to boston scientific corporation on july 05, 2022 that a wallflex biliary rx partially covered stent was implanted to treat a pancreatic cancer during a stent placement procedure performed in (b)(6) 2021.Post stent placement, on an unknown date, a whipple procedure was to be performed; however, it was found that the wallflex biliary stent had eroded to the inferior vena cava.The wallflex biliary stent was unable to be removed and surgery was also unable to be performed to remove the tumors due to the migrated stent.The patient died in (b)(6) 2022 (exact date unknown).
Additional Manufacturer Narrative
Patient's death is reported to be on (b)(6) 2022.Date of event: approximated based on the date the wallflex biliary stent was implanted.Initial reporter: the name of the second physician is: dr.(b)(6).(b)(4).The patient expired, the stent remained implanted and will not be returned for evaluation; therefore, a device analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block b2: patient's death is reported to be on (b)(6) 2022.Block e1: the name of the second physician is: dr.(b)(6).Block h6: medical device problem code a010402 captures the reportable event of stent migration.Medical device problem code a150207 captures the reportable event of stent difficult to remove.Block h11: correction on block b3 statement: approximated based on the date the patient died post wallflex biliary stent placement.Block d6a has been corrected.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex biliary rx partially covered stent was implanted to treat a pancreatic cancer during a stent placement procedure performed in (b)(6) 2021.Post stent placement, on an unknown date, a whipple procedure was to be performed; however, it was found that the wallflex biliary stent had eroded to the inferior vena cava.The wallflex biliary stent was unable to be removed and surgery was also unable to be performed to remove the tumors due to the migrated stent.The patient died in (b)(6) 2022 (exact date unknown).

• 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: 15137737
• Report Number: 3005099803-2022-04106
• Device Sequence Number: 7295911
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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: 02/27/2022
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 0025280527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 08/01/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Sex: Male