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

Model Number	26280
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent could not be deployed, so it was cut and removed.A 12mm x 90mm wallstent uni was selected for use in a stenting procedure in the severely stenosed iliac vein.After advancing the device to the lesion, the stent could not be fully deployed.The physician cut and removed the device.The procedure was completed with a different device.No patient complications were reported, and the patient was stable following the procedure.
Event or Problem Description
It was reported that stent could not be deployed, so it was cut and removed.A 12mm x 90mm wallstent uni was selected for use in a stenting procedure in the severely stenosed iliac vein.After advancing the device to the lesion, the stent could not be fully deployed.The physician cut and removed the device.The procedure was completed with a different device.No patient complications were reported, and the patient was stable following the procedure.It was further reported that the stent failed to completely deploy and could not be retrieved so the physician had to cut the puncture point to remove the device.It was noted that stent interaction with other devices occurred during the procedure.Furthermore, the patient experienced pain during removal.
Additional Manufacturer Narrative
B5.Event description; h6.Patient codes, impact codes, and device codes were all updated, per the additional information.Device evaluated by mfr.: a wallstent uni was returned for analysis,.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was received with the stent deployed from the delivery system.The deployed stent was not returned for analysis.This concludes the product analysis.
Event or Problem Description
It was reported that stent could not be deployed, so it was cut and removed.A 12mm x 90mm wallstent uni was selected for use in a stenting procedure in the severely stenosed iliac vein.After advancing the device to the lesion, the stent could not be fully deployed.The physician cut and removed the device.The procedure was completed with a different device.No patient complications were reported, and the patient was stable following the procedure.It was further reported that the stent failed to completely deploy and could not be retrieved so the physician had to cut the puncture point to remove the device.It was noted that stent interaction with other devices occurred during the procedure.Furthermore, the patient experienced pain during removal.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13067503
• Report Number: 2134265-2021-16157
• Device Sequence Number: 20241480
• Product Code: MAF
• UDI-Device Identifier: 08714729203971
• UDI-Public: 08714729203971
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2022

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: 05/27/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0027396424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/20/2021; 01/27/2022
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 01/14/2022; 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/27/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 57 KG