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

Model Number	26280
Medical Device Problem Codes	Mechanical Problem (1384); Premature Activation (1484); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Event or Problem Description
It was reported that the stent was damaged during expansion and required an additional device.The approximately 70%-80% stenosed target lesion was located in the non-tortuous and non-calcified superior vena cava.A 22x70/10fr uni plus 75cm wallstent endoprosthesis was advanced to treat the lesion.However, after the stent entered the vascular sheath, the device failed to cover the lesion and was stuck on the outer sheath during deployment.This results in stent being damaged and changing of puncture point.The device was simply pulled out along with the outer sheath.The procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that the stent was damaged during expansion and required an additional device.The approximately 70%-80% stenosed target lesion was located in the non-tortuous and non-calcified superior vena cava.A 22x70/10fr uni plus 75cm wallstent endoprosthesis was advanced to treat the lesion.However, after the stent entered the vascular sheath, the device failed to cover the lesion and was stuck on the outer sheath during deployment.This results in stent being damaged and changing of puncture point.The device was simply pulled out along with the outer sheath.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the 80% stenosed target lesion was located in the mildly tortuous superior vena cava.However, during deployment, the sheath was punctured.The device was reconstrained after removal.
Additional Manufacturer Narrative
Device eval by mfr: a wallstent uni device was received for analysis.The device was returned with the stent deployed from the delivery system.No issues noted with the deployed stent.A visual examination identified no damage or issues with the stent cups or stent holder of the returned device.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile examination identified multiple sheath kinks.B5: describe event or problem: updated e1: initial reporter phone: (b)(6).

• Brand Name: WALLSTENT ENDOPROSTHESIS
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18141616
• Report Number: 2124215-2023-64110
• Device Sequence Number: 12762237
• Product Code: JCT
• UDI-Device Identifier: 08714729204145
• UDI-Public: 08714729204145
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: 06/08/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0029557694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2023
• Supplement Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 56 KG