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	01/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that stent foreshortening occurred.The patient presented with lower limb embolism and underwent thrombectomy.The <50% stenosed target lesion was located in the mildly calcified and mildly tortuous lower limb vein.A 14x60/9fr uni plus 75cm wallstent uni endoprosthesis was advanced for treatment.During the procedure, the selected size was placed in the patient's body, however, the stent was shorter than the actual size.Before procedure, the length of the stent was 60 according to the external packaging.The actual measurement of stent propulsion in vivo was less than 60.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.
Additional Manufacturer Narrative
E1: initial reporter address 1: no.(b)(6).Device evaluated by mfr.: the device was received with the stent in the correct position on the delivery system.The stent was able to be successfully deployed without issue.A visual examination found no damage or issues with the deployed stent.The nominal length of the stent was measured at 62mm, which is within specification.A visual examination found no issues with the stent cups or stent holder.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual and tactile examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that stent foreshortening occurred.The patient presented with lower limb embolism and underwent thrombectomy.The <50% stenosed target lesion was located in the mildly calcified and mildly tortuous lower limb vein.A 14x60/9fr uni plus 75cm wallstent uni endoprosthesis was advanced for treatment.During the procedure, the selected size was placed in the patient's body, however, the stent was shorter than the actual size.Before procedure, the length of the stent was 60 according to the external packaging.The actual measurement of stent propulsion in vivo was less than 60.The procedure was completed with another of same device.No patient complications were reported and the patient status was stable.

• 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: 16247330
• Report Number: 2124215-2023-00951
• Device Sequence Number: 12413513
• Product Code: MAF
• UDI-Device Identifier: 08714729204008
• UDI-Public: 08714729204008
• 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): 03/15/2023

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: 0029286372
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/15/2023
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 60 KG