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

Model Number	26280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	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 the stent foreshortened.The 50% stenosed lower extremity vein was treated with balloon expansion and venous stenting.A 14mm x 90m wallstent uni stent was implanted.Another 14mm x 90m wallstent uni stent was planned.While delivering the second stent normally, half of the stent overlapped the previously placed one, and it was deployed slowly.When the stent was fully deployed, it appeared that the stent was severely shortened.The overlapped portion of the two stents was less than 1cm.A balloon was used, and the two stents detached from each other.The procedure was completed with a different device.No patient complications were reported, and the patient was stable following the procedure.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A visual examination found the stent had been deployed.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination found the shaft to be kinked at approximately 13mm proximal from the distal tip.This type of damage is consistent with excessive force being applied to the device.
Event or Problem Description
It was reported that the stent foreshortened.The 50% stenosed lower extremity vein was treated with balloon expansion and venous stenting.A 14mm x 90m wallstent uni stent was implanted.Another 14mm x 90m wallstent uni stent was planned.While delivering the second stent normally, half of the stent overlapped the previously placed one, and it was deployed slowly.When the stent was fully deployed, it appeared that the stent was severely shortened.The overlapped portion of the two stents was less than 1cm.A balloon was used, and the two stents detached from each other.The procedure was completed with a different device.No patient complications were reported, and the patient was stable following the procedure.

• 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: 13172721
• Report Number: 2134265-2021-16467
• Device Sequence Number: 14592841
• Product Code: MAF
• UDI-Device Identifier: 08714729204015
• UDI-Public: 08714729204015
• 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
• Report Date (Section B): 01/28/2022

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: 07/20/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0027696966
• 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: 12/13/2021
• Supplement Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 60 KG