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	08/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent foreshortening occurred.The target lesion was located in iliac vein.After the guidewire was inserted and pre-dilation was performed, a 16x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, during deployment, the proximal of the stent was shrinked at 1-1.5cm.The lesion was overlapped with another 16x90 stent and pre-dilated again with balloon catheter.The vessel monorlogy was good but the proximal part of second stent was also shrinked at about 2cm, which affected the positioning.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
Event or Problem Description
It was reported that stent foreshortening occurred.The target lesion was located in iliac vein.After the guidewire was inserted and pre-dilation was performed, a 16x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, during deployment, the proximal of the stent was shrinked at 1-1.5cm.The lesion was overlapped with another 16x90 stent and pre-dilated again with balloon catheter.The vessel monorlogy was good but the proximal part of second stent was also shrinked at about 2cm, which affected the positioning.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was severely stenosed and was 30-40mm in length.The first stent which shrank at 1-1.5cm was a 14x90/9fr wallstent endoprosthesis.Additionally, a balloon was used to push the second stent ahead at the opening to correct the shrinkage which had affected the positioning.
Additional Manufacturer Narrative
E1: initial reporter city: corrected from (b)(6).
Event or Problem Description
It was reported that stent foreshortening occurred.The target lesion was located in iliac vein.After the guidewire was inserted and pre-dilation was performed, a 16x90/9fr uni plus 75cm wallstent endoprosthesis was advanced for treatment.However, during deployment, the proximal of the stent was shrinked at 1-1.5cm.The lesion was overlapped with another 16x90 stent and pre-dilated again with balloon catheter.The vessel monorlogy was good but the proximal part of second stent was also shrinked at about 2cm, which affected the positioning.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.It was further reported that the target lesion was severely stenosed and was 30-40mm in length.The first stent which shrank at 1-1.5cm was a 14x90/9fr wallstent endoprosthesis.Additionally, a balloon was used to push the second stent ahead at the opening to correct the shrinkage which had affected the positioning.

• 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: 15540157
• Report Number: 2124215-2022-36866
• Device Sequence Number: 6073841
• Product Code: MAF
• UDI-Device Identifier: 08714729204053
• UDI-Public: 08714729204053
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K152842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 12/06/2022

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: 11/04/2023
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0028328278
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 10/08/2022; 11/16/2022
• Initial Report FDA Received Date: 10/04/2022
• Supplement Report FDA Received Date: 10/20/2022; 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2021
• 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: 52 YR
• Patient Sex: Female
• Patient Weight: 46 KG