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

Model Number	26280
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 14x90/9fr uni plus 75cm was received for analysis.The device was received with the stent in the correct position on the device.The stent was successfully deployed with a little resistance due to kinking to the shaft of the device.A visual examination identified damaged to the centre of the deployed stent.The stent damage noted is located at the same location as the shaft kinking when the stent was mounted on the delivery system.Both the inner and outer shaft of the device were found to be kinked at more than one location and at the same location.This type of damage is consistent with excessive force being applied to the device.A visual examination identified no damage or issues with the stent holder, stent cups or tip of the device that could potentially have contributed to the complaint incident.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that stent failure to deploy occurred.The stenosed target lesion was located in the iliac vein.A 75cm wallstent endoprosthesis selected for use.Prior to the procedure, the stent could not be deployed upon flushing.The procedure was completed with another of the same device.There were no complications reported and the patient was stable.However, returned device analysis revealed stent damage.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15881774
• Report Number: 2124215-2022-47621
• Device Sequence Number: 2532174
• 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
• Report Date (Section B): 11/29/2022

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: 11/10/2022
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0026332797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 11/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/10/2020
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 74 KG