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

Model Number	26280
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1.Initial reporter phone:(b)(6).
Event or Problem Description
It was reported that stent partially deployed occurred.A balloon angioplasty was performed on the lower limb.The non-stenosed target lesion was located in the severely tortuous and non-calcified iliac vein.Pre-dilatation was performed with a non-boston scientific (bsc) balloon and a 14x60/9fr uni plus 75cm wallstent endoprosthesis was advanced but failed to cross the lesion.However, angiography showed the tip of the stent was exposed and partially deployed.In addition, the stent was completely reconstrained during withdrawal.The physician was afraid of damaging the blood vessels, so the procedure was completed with another of the same stent.There were no patient complications reported, and patient status was stable post-procedure.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).Device evaluated by mfr: 14x60/9fr uni plus 75cm was received for analysis.The device was returned with the stent fully constrained in the correct position on the delivery system.The investigator successfully deployed the stent without issue.No damage or issues were 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 found no kinks or damage to the sheath of the device.
Event or Problem Description
It was reported that stent partially deployed occurred.A balloon angioplasty was performed on the lower limb.The non-stenosed target lesion was located in the severely tortuous and non-calcified iliac vein.Pre-dilatation was performed with a non-boston scientific (bsc) balloon and a 14x60/9fr uni plus 75cm wallstent endoprosthesis was advanced but failed to cross the lesion.However, angiography showed the tip of the stent was exposed and partially deployed.In addition, the stent was completely reconstrained during withdrawal.The physician was afraid of damaging the blood vessels, so the procedure was completed with another of the same stent.There were no patient complications reported, and patient status was stable post-procedure.

• 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: 18144627
• Report Number: 2124215-2023-61922
• Device Sequence Number: 12640549
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: 10/23/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 12/12/2023
• 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: 57 YR
• Patient Sex: Female
• Patient Weight: 56 KG