MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	26265
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: a 8x60x75/ 6f unistep plus was received for analysis.The device was received with the stent partially deployed in position on the inner shaft.The stent wires at the distal end of the stent were noted to be damaged.The stent was successfully deployed with a little resistance encountered due to shaft damage.A visual and tactile inspection identified no issues with the tip of the device.The distal edge of the outer shaft was found to be damaged.The shaft was also found to have accordion damage beginning approximately 165mm proximal of the distal edge and extending approximately 50mm proximally.The shaft was also noted to be kinked at approximately 135mm distal of the main valve of the device.This type of damage is consistent with the excessive force being applied to the device, possible during the attempt to cross the lesion.No other issues were noted with the delivery system that could potentially contributed to the complaint incident.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2022.It was reported that stent partial deployment and shaft damage occurred.The target lesion was severely stenosed.A 8x60x75/ 6f wallstent rp endoprosthesis stent was advanced for treatment.However, during the procedure, it was noticed that the stent could not be push when pushed for a half.After several attempts, the sheath was noted to be wrinkled after removal.The device was removed fully reconstrained and the procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.However, returned device analysis revealed that the stent was partially deployed and was damaged.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• 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: 15852502
• Report Number: 2124215-2022-46292
• Device Sequence Number: 5225986
• Product Code: FGE
• UDI-Device Identifier: 08714729406396
• UDI-Public: 08714729406396
• 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
• Report Date (Section B): 11/23/2022

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: 02/04/2024
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0028810743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2022
• Initial Report FDA Received Date: 11/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 72 KG