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

Model Number	26280
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent positioning difficulties were encountered.The patient was to undergo iliac vein stent implantation.The target lesion was located in the severely tortuous iliac vein.After the lesion was pre-dilated with a 12.6 non-boston scientific balloon catheter, a 14x90/9fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during the procedure, it was noticed that the stent was shrinking badly, and it could not reach the position after multiple attempts.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).Device evaluated by mfr: the device 14x90/9fr uni plus 75cm was returned with the stent in the correct position on the delivery system.A visual and tactile examination identified no issues with the tip of the device.A visual and tactile inspection identified no kinks or damage to the sheath or shaft of the device.
Event or Problem Description
It was reported that stent positioning difficulties were encountered.The patient was to undergo iliac vein stent implantation.The target lesion was located in the severely tortuous iliac vein.After the lesion was pre-dilated with a 12.6 non-boston scientific balloon catheter, a 14x90/9fr uni plus 75cm wallstent endoprosthesis stent was advanced for treatment.However, during the procedure, it was noticed that the stent was shrinking badly, and it could not reach the position after multiple attempts.The procedure was completed with another of the same device.No patient complications were reported and the patient was stable.

• 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: 18136165
• Report Number: 2124215-2023-63954
• Device Sequence Number: 7999205
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2023

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: 04/25/2024
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0029286379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 11/14/2023
• Supplement Report FDA Received Date: 12/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 55 KG